Posted: 24 Jul 2015 03:52 AM PDT
By Kurt R. Karst –
Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016,” would give FDA a small increase over Fiscal Year 2015 funding. In addition to funding FDA, however, the bills (S. 1800 and H.R. 3049) and their accompanying reports (H. Rept. 114-205 and S. Rept. 114-82) heap on various recommendations and directives. We’ve extracted those items from each of the documents and added some links to background information. We’re not going to get into all of the appropriations funding numbers. Instead, we’ll leave that to the folks over at the Alliance for a Stronger FDA, who have provided initial break-outs of both the Senate and House appropriations bills (here and here).
House Fiscal Year 2016 FDA Appropriations Bill (H.R. 3049) & Report (H. Rept. 114-205)
The following provisions are included as “General Provisions” in Title VII of H.R. 3049:
Funding for Food Safety. – The Committee includes increases of $41,500,000 for the implementation of the FSMA. These increases consist of: $18,500,000 for Inspection Modernization and Training; $5,000,000 for the National Integrated Food Safety System; $11,500,000 for Education and Technical Assistance for Industry; $2,500,000 for Technical Staffing and Guidance Development; $3,000,000 for Import Safety; and $1,000,000 for Risk Analytics and Evaluation. The increases provided in this bill and the increases provided since fiscal year 2011 should assist the FDA in preparation for the implementation of FSMA prior to the effective dates of the seven foundational proposed rules. While the FDA has not implemented the final rules, the Committee understands that most businesses will not need to comply with the two rules for preventive controls for human food and for animal food until August 2016 and that the other five rules will not be effective until fiscal year 2017 and later.
The Committee notes that with these increases, the estimated total funding for food safety since FSMA was signed into law on January 4, 2011, would be over $230 million. In addition to the increases for FSMA, the FDA utilizes base resources for its comprehensive food safety efforts. Prior to the Committee's investment in food safety activities related to FSMA over the past five years, FDA reported that it spent $785 million for food safety in fiscal year 2009 and had an appropriation for food safety of $952.9 million in fiscal year 2010. While some of these base resources prior to the enactment of FSMA covered statutory responsibilities that are not directly linked to FSMA, a large majority of such funds do relate to FSMA and should be accounted for accordingly. The Committee continues to seek far more information on how the agency is spending its resources for FSMA related activities from increased funding and base resources. Therefore, the Committee directs the FDA to provide a detailed accounting of its food safety resources in the fiscal year 2017 budget request, including which pre-2011 base resources are now repurposed for activities in support of FSMA and which resources are the result of appropriated increases from fiscal years 2011 to 2016, a detailed explanation of what the FDA has accomplished with increased food safety resources since fiscal year 2011, and how the aggregate total of these base resources for food safety will be utilized in fiscal year 2017.
Medical Product Safety Funding. – The Committee provides an increase of $4,216,000 for medical product safety initiatives. Included in this amount is $2,500,000 for combating antibiotic resistant bacteria as part of the National Strategy for Combating Antibiotic Resistant Bacteria (CARB), $1,000,000 for the Precision Medicine initiative, and $716,000 for the evaluation of over the counter sunscreen products. According to the FDA's fiscal year 2016 budget request, the Agency is spending approximately $32.5 million on antimicrobial resistance activities in fiscal year 2015. With this increase, the FDA is expected to spend approximately $35 million on combating antibiotic resistance in fiscal year 2016.
Active Pharmaceutical Ingredients. – The Committee is concerned that the FDA has not yet approved a list of Active Pharmaceutical Ingredients (APIs) for use by compounding pharmacists pursuant to the Drug Quality and Security Act (Public Law [113-54], 127 Stat. 587) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a et seq.). Within 90 days of enactment of this Act, the FDA shall report to Congress on when its review of proposed APIs pursuant to Sec. 503A(1)(a)(iii) will be completed.
Antibiotics. – The Committee urges the FDA to work to foster the development of new antibiotics by supporting greater collaboration between industry and the FDA around adaptive clinical trials and labeling changes. The President’s Council of Advisors on Science and Technology has recommended this proposal to help support the type of robust drug development that will be needed to ensure patients are protected from bacterial resistance.
Bioethics. – The Committee notes that the FDA commissioned a consensus study from the Institute of Medicine (IOM) on “Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases.” The Committee further notes that the FDA has requested that the IOM produce a consensus report on the ethical and social policy issues related to genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease. The Committee directs the FDA to establish an independent panel of experts, including those from faith-based institutions with expertise on bioethics and faith-based medical associations, and to submit this consensus report to the independent panel of experts upon its completion by the IOM. The Committee urges the independent panel of experts to review the IOM report and report their evaluation of its conclusions, along with any recommendations based on this review, to the Committee within 30 days of the completion of the report by the IOM.
Biological Products. – The Committee commends the FDA for issuing draft guidance to address the mixing, diluting, or repackaging of biological products outside the scope of an approved biologics license application. The Committee urges the FDA to finalize the guidance without delay following the public comment period and continues to emphasize the need for close FDA inspection and supervision of large-scale compounding and repackaging of sterile injectable drugs and biological products, particularly products that are administered into areas of the human body where there is tempered immunity, such as the eye or spinal column, to ensure that they are processed in keeping with current good manufacturing practice for sterile products, in particular 21 CFR 200.50 regarding ophthalmic preparations.
Biosimilars–Naming and Interchangeability – Five years post-enactment of the Biologics Price Competition and Innovation Act (BPCIA), FDA has only released guidances on general issues like scientific considerations in demonstrating biosimilarity, how exclusivity for innovator products may be applied, and how FDA will conduct industry/applicant meetings. These guidances do not address in any way the key considerations affecting patients or providers, such as what biosimilars will be named so that patients and their providers know which specific therapy a patient receives, for which indications can a biosimilar or interchangeable product be used, and scientific considerations for determining interchangeability. Due to the absence of these guidances the FDA was forced to approve biosimilar Zarxio with a “placeholder” name. The Committee finds this unacceptable and directs the FDA to issue naming and interchangeability guidances no later than November 30, 2015.
Blood Plasma Products. – The Committee notes that the FDA has followed the Committee's advice from fiscal year 2015 and is addressing the issue of the use of plasma for post-collection manufacture into critical plasma derivatives, no matter the manner in which the blood is collected. The Committee urges the FDA to prioritize developing policies to allow for the more timely use of plasma from automated donations into other biologics and asks that the FDA update the Committee on its progress with a report no later than 60 days after enactment of this Act.
Blood Product Policies. – Last December, the FDA released draft guidance for industry entitled “Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.” As the agency is aware, the Committee issued report language in fiscal year 2012 expressing concern for the safety risks to transfusion patients from bacterially contaminated platelets. The Committee is pleased to see the agency take the step of releasing draft guidance. Unfortunately, when the FDA released its guidance agenda for 2015, the final version of this draft guidance was not listed among the agency’s priorities. This is an important safety issue, and it is essential that the agency complete the guidance process in a timely manner. The Committee urges the FDA to do so as quickly as possible.
Centers of Excellence – The Committee is aware of the important contribution of CFSAN’s Food Safety Centers of Excellencein supporting critical basic research as well as facilitating the implementation of the Food Safety Modernization Act. The Committee encourages the agency to continue to fully utilize the Centers of Excellence to accomplish these goals and to enhance its level of support for Food Safety Modernization Act activities and to increase funding for base work.
Cord Blood Regulation. – The Committee directs the FDA to undergo a review and seriously consider the potential need for revision of the current regulatory requirements for cord blood licensure, particularly those related to manufacturing and storage, to ensure the correct applicability to this industry since the current regulatory requirements are the same ones that apply to pharmaceutical products. In addition, the Committee directs the FDA to create an advisory task force, comprised at a minimum of public and private cord blood bankers, transplanters and patients, to provide recommendations to the agency about the current licensing requirements and changes that may be necessary.
Cosmetics and Colors. – The Committee directs the FDA to spend no less than the fiscal year 2015 level for cosmetics activities as well as for the Office of Colors and Cosmetics (OCAC). Funding provided for OCAC is for direct support of the operation, staffing, compliance, research and international activities performed by this office.
The Committee notes that, for the past five years, it has directed the FDA to respond to the Citizen Petition requesting that the FDA establish a safe level for lead as a nonfunctional constituent in lipstick. The Committee is aware that in 1975 the cosmetic industry asked the FDA to evaluate the safety of ingredients found in its products. Consistent with this commitment, in 1976 the cosmetic industry established the Cosmetic Ingredient Review (CIR) under which the safety of approximately 3,880 ingredients has been reviewed by an Expert Panel of independent scientists, and the FDA has participated through a nonvoting liaison at all meetings of the Expert Panel. The Committee directs the FDA to respond to the Citizen Petition on this lipstick ingredient by December 31, 2015.
Cosmetic Ingredient Review Panel. – As noted, the cosmetic industry established the CIR as a means to assure the safety of ingredients in cosmetic products. Given the breadth and volume of ingredients reviewed and the scientific expertise applied to its process, it is the Committee's belief CIR should be recognized and formalized as a public-private program. The Committee therefore directs that the FDA work with the cosmetic industry to transfer the CIR to the United States Pharmacopeia Convention (USP) or some other appropriate third body for the purpose of evaluating and determining the safety of ingredients found in cosmetics. USP is a widely respected independent scientific organization whose drug standards are explicitly incorporated under the Federal Food, Drug, and Cosmetic Act (FDCA). The Committee directs that the FDA, working cooperatively with the cosmetic industry, report back to the Committee no later than January 15, 2016, with a framework and a detailed plan.
Drug Compounding. – The Committee is concerned that, since passage of the Drug Quality and Security Act (DQSA) of 2013, the FDA has interpreted provisions of Section 503A of the FDCA in a manner inconsistent with its legislative intent and with the agency’s own previous positions. Specifically, the FDA has taken the position that under 503A, a pharmacist may not compound medications prior to receipt of a prescription and transfer the drugs to a requesting physician or other authorized agent of the prescriber for administration to his or her patients without a patient-specific prescription accompanying the medication. This practice, which is often referred to as “office-use” compounding [(see our previous post here)], is authorized in the vast majority of states and was intended to be allowable under DQSA. The Committee is aware that in 2012, prior to passage of the DQSA, FDA was working on a draft compliance policy guide for 503A of the FDCA that provided guidance on how “office-use” compounding could be done consistent with the provisions of 503A. The Committee understands the intent of the DQSA was not to prohibit compounding pharmacists from operation under existing 503A exemptions; therefore, the Committee directs the FDA to issue a guidance document on how compounding pharmacists can continue to engage in “office-use” compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A within 90 days after the enactment of this Act.
Drug Labeling Approval. – The Committee acknowledges FDA's actions over the past six months regarding the proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” to include a listening session on March 27, 2015, and a reopened comment period that closed on April 27, 2015. However, the Committee continues to be concerned with FDA actions from the beginning of this process and the subsequent failure to find closure on this issue. As things currently stand, the rule would allow a generic drug manufacturer to alter its safety labeling unilaterally without FDA’s prior approval, even if there is more than one generic manufacturer or an innovator manufacturer and generic manufacturer marketing the same bioequivalent drug (a “multisource” drug), and other companies are not required to make a corresponding labeling change.
The proposed rule has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for bioequivalent products. The Committee urges the FDA to finalize the rule based upon comments it received in the docket and during the March 27 public meeting to meet the stated objectives of ensuring that patients have the most complete and up-to-date information regarding their prescription drugs. The final rule should establish: (1) FDA as the final decision maker of whether or not a manufacturer should change its labeling in a multisource environment; (2) a process by which the FDA collects and utilizes all safety information to determine if a labeling change is required–from the new safety information from the manufacturer to sources such as the Sentinel System and other global databases; (3) a process by which the FDA has defined time parameters to take action on new safety information provided by innovator or generic application holders; and, (4) a process by which manufacturers should have a defined time period to make the corresponding labeling change. A final rule with these minimum requirements should be grounded in scientific evidence, and present no opportunity for mismatched dispensing or use information between the innovator drug and the generic version drug.
Drug Shortages. – The Committee is aware that shortages of critical drugs persist following the 2012 enactment of the Food and Drug [Administration] Safety and Innovation Act (FDASIA). Surveys conducted by the American Association of Nurse Anesthetists, the American Hospital Association, and the American Society of Health-System Pharmacists report persistent shortages of drugs used in anesthesia care, oncology, and other services, owing primarily to problems in manufacturing, which impair patient access to care and patient experiences in the healthcare system, delay surgical procedures, and possibly increase overall healthcare costs. Therefore, within the funding provided the Committee directs the Commissioner to continue to prioritize the public reporting of manufacturing shortages, and to work with industry to prevent conditions that might lead to drug shortages.
The Committee remains concerned about national shortages of drugs to test for and treat Tuberculosis (TB), and recognizes that shortages could lead to further TB transmission as well as the development of drug resistance. The FDA is encouraged to ensure that TB control partners are participating in the Drug Shortages Interagency Task Force, including representatives of the Centers for Disease Control and Prevention, the Office of Emergency Preparedness and Response, and the Federal TB Task Force. The Committee requests a report on steps the FDA can take to prevent TB drug shortages and help maintain an adequate supply.
Duchenne Muscular Dystrophy. – The Committee is aware that the FDA recently released draft guidance for the development of drugs to treat Duchenne Muscular Dystrophy and related issues. The Committee commends FDA for working with patient groups and urges them to continue this collaborative approach when evaluating the medical needs of a rare disease community.
FDA Partnerships Under FSMA. – The purpose of FSMA is to reform the nation's food safety laws to ensure a safe public food supply. As the FDA continues implementation of FSMA, the Committee encourages the FDA to work in partnership with existing government food safety programs, including the use of MOUs, to verify compliance with FSMA rules once they are finalized as a way to eliminate duplication of activities under the law. In addition, the Committee provides an increase of $2.5 million for the Food Safety Outreach Program under NIFA, and expects that, per the proposal in the President’s fiscal year 2016 budget request, NIFA will serve as the sole agency providing food safety training, education, outreach, and technical assistance at the farm level.
Food Contact Notification User Fees. – The funds made available by this Act include sufficient monies to fund the FDA’sFood Contact Notification Program and shall be deemed to satisfy the requirements of 21 U.S.C. 348(h)(5)(A). The Committee recommendation does not include proposed user fees.
Generic Drug User Fee Facility Fees. – When the FDA begins the process for GDUFA reauthorization negotiations on June 15, 2015, the Committee urges all stakeholders to carefully consider providing fee waivers, exemptions, or otherwise reduced fees for small generic drug manufacturers to minimize the disproportionate financial burden on these companies.
Genomic Editing. – The Committee understands the potential benefits to society in the genetic modification of living organisms. However, researchers do not yet fully understand all the possible side effects of editing the genes of a human embryo. Editing of the human germ line may involve serious and unquantifiable safety and ethical issues. Federal and non-Federal organizations such as the National Academy of Sciences and National Academy of Medicine will soon engage in more extensive scientific analysis of the potential risks of genome editing and a broader public discussion of the societal and ethical implications of this technique. In accordance with the current policy at the National Institutes of Health, the Committee includes bill language that places a prohibition on the FDA’s use of funds involving the genetic modification of a human embryo. The Committee continues to support a wide range of innovations in biomedical research, but will do so in a fashion that reflects well-established scientific and ethical principles.
Harm Reduction. – It is the Committee recommendation that the FDA consider the benefits of harm reduction as part of evaluations under the Deeming regulations for tobacco products.
Imported Pet Food Product Transparency. – As of May 15, 2015, the FDA had received approximately 5,200 reports of pet illness related to consumption of jerky pet treats, nearly all of which are imported from China. The reports involve more than 6,000 dogs, 26 cats, and 3 humans and include more than 1,100 canine deaths. These incidents date back to 2007. The Committee requests that the FDA provide it with a summary of all activities associated with the investigation into the pet illnesses associated these products, including any import alerts and import refusals, within 60 days of the enactment of this Act. In addition, the Committee requests that the agency provide it with semi-annual reports on the status of the investigation into these illnesses beginning in April 2016 until the issue has been resolved.
Late Reports. – The Committee reminds the Commissioner that the timelines specified by the Committees on Appropriations of the House and Senate for fiscal year 2015 reports are deadlines that must be met. While the Committee notes that the FDA has made progress in providing more timely information and updates, the FDA still has several outstanding reports that are delayed due to long reviews and clearances. The Committee directs the Commissioner to submit these overdue reports. [(See our previous post here.)]
Local Port Cooperation – The Committee directs FDA to work with local governments at high volume ports of entry to explore activities which reduce the risk of food borne llnesses and enhance the capacity of local officials in dealing with food borne threats.
Mammography Quality Assurance Advisory Committee. – More than three years ago, in November 2011, theNational Mammography Quality Assurance Advisory Committee approved a change to the mammogram patient report and physician report to include information regarding an individual’s breast density. This process has not been completed. The Committee urges the FDA to implement this change in an expedited manner and must report to Congress on the status of this change no more than 60 days from the enactment of this Act.
Medical Countermeasures. – The Committee directs that not less than $24,552,000 shall be available for the FDA’sMedical Countermeasures Initiative. This total is in addition to the unobligated funds remaining to support the FDA’s emergency response to Ebola and related disease outbreaks.
Medical Gas Rulemaking. – The Committee is concerned that the FDA has not initiated rulemaking to address numerous longstanding regulatory issues for medical gases despite the statutory requirement in FDASIA to issue a final rulemaking addressing all necessary changes for medical gases by July 9, 2016. Designated medical gases are a unique class of drugs that differ significantly from traditional pharmaceuticals and therefore must be addressed in the Federal drug regulations to prevent safety and enforcement issues caused by current regulations. The FDA has never responded to a 1979 Citizens Petition on expiration dating or a 1994 Citizens Petition on calculation of yield, and has not responded to a January 2014 statutorily required report on medical gas regulatory review. Therefore, the FDA shall issue a proposed rulemaking to address each and every regulatory issue that creates safety and enforcement issues for medical gases by September 30, 2015.
Menu Labeling. – The Committee is concerned about recent FDA final determination that increased the size and scope of those affected under restaurant menu labeling regulations. Specifically, the final rule attempts to regulate local grocery chains that typically do not qualify as restaurants. These newly regulated entities do not have clear guidance from the FDA as to how they must comply with numerous provisions of the final regulation. The Committee includes bill language that directs the FDA to implement the final rule no earlier than December 1, 2016, and at least one-year following agency publication of related guidance to newly regulated stakeholders. [(See our previous post here.)]
Molluscan Shellfish – The Committee is concerned that non-tariff trade barriers continue to preclude trade in molluscan shellfish with European Union states. The Committee encourages the agency to expedite its audit of growing areas in Europe and to seek equivalency in sanitary standards where possible to allow a resumption of trade.
Off-Label Guidance. – The Committee notes that in December of 2011, the FDA issued “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices”, and a request for comment to assist the agency in evaluating policies for off-label uses of both approved and investigational drugs and devices. The comment period closed on March 27, 2012. Further, the FDA responded in June 2014 to two citizen petitions that were submitted to the agency in July of 2011 and September of 2013 requesting clarification of regulations and policies regarding certain communications related to investigational new drugs and investigational new devices and off-label uses of drugs and devices. In the FDA’s response, the agency stated, “that it plans to issue guidance that addresses unsolicited requests, distributing scientific and medical information on unapproved new uses and manufacturer discussions regarding scientific information more generally, by the end of the calendar year.”
The Committee is concerned that the FDA has yet to issue new guidelines regarding the manner in which truthful and non-misleading scientific information outside of a product label for prescription drugs and medical devices can be conveyed. The Committee directs the FDA to address this issue comprehensively, outlining how manufacturers can communicate with all healthcare stakeholders, and to complete such guidelines within 60 days of enactment of this Act.
Over the Counter (OTC) Medicines for Children – The Committee is concerned that the FDA has not issued a proposed rule revising the monograph regulating the labeling of OTC cough and cold products for children. The Committee directs the agency to publish a proposed rule by November 30, 2015, based on scientific evidence for safety and efficacy in pediatric populations and taking into consideration the October 19, 2007 joint recommendations of its Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee. While the Committee appreciates the agency's effort to explore possible improvements to the OTC drug monograph process; these efforts should not impede the prompt publication of this proposed rule.
Partially Hydrogenated Oils. – The Committee is concerned that the FDA’s recent final determination that partially hydrogenated oils (PHOs) are no longer Generally Recognized as Safe (GRAS) could cause economic disruption in the marketplace and lead to unnecessary litigation [(see our previou spost here)]. More importantly, the FDA should clarify that they have not concluded that PHOs are unsafe but that they no longer meet the general recognition element of the GRAS standard. Further, it is disturbing that the FDA would make such a determination without full public documentation of the data and process used to do so. Therefore, the Committee directs the FDA, in carrying out its enforcement of this determination, to: 1) issue a notice that it will delay the effective date of the final determination until acting on a Food Additive Petition following the procedures identified in 21 C.F.R. 170 38(c); 2) provide a reasonable transition period of 3 years for companies to reformulate products that would allow the marketing of current uses of PHOs during this transition period; 3) clarify that the final determination applies prospectively and after the agency issues the food additive regulation; and (4) that the FDA clarify that products containing PHOs prior to and during this transition period be deemed lawful and in compliance with the FDCA, and not seek to enforce any ban on the introduction of PHOs into commerce until after the revised effective date.
Pharmacy Compounding. – The Committee is very concerned with the draft MOU that the FDA has proposed under Section 503A of the FDCA [(see our previous post here)]. The proposed MOU would complicate patient and prescriber access to compounded medications, and may have a deleterious effect on small pharmacies. Under the draft MOU, the FDA attempts to describe “distribution” as occurring when “a compounded human drug product has left the facility in which the drug was compounded.” In the DQSA, Congress only allowed the FDA to regulate “distribution.” But the MOU appears to exceed the authority granted in the statue by redefining “distribution'' in a manner that includes dispensing–something unprecedented. This overreach could generate exactly the kind of costly and confusing litigation that Congress intended to avoid when it amended and reinstated Section 503A. The Committee expects that, when a final MOU is proposed as a model agreement for the states to consider, that distribution and dispensing are treated as the different and separate activities that they actually are.
Pollock Nomenclature. – The Committee directs the Commissioner to expedite consideration of whether it is appropriate to change the acceptable market name of Gadus chalcogrammus (formerly classified as Theragra chalcogramma) from “Alaska Pollock” to “Pollock” in the Seafood List. It is critical that seafood nomenclature (acceptable market names) is science-based, truthful, and not misleading to the consumer.
Prescription Drug Labeling Inserts. – The Committee is aware of FDA proposals that would subvert repeatedly expressed Congressional intent by permitting the distribution of prescription drugs without printed prescribing information on or within the packages from which such drugs are to be dispensed [(see our previous post here)]. The FDA intends to replace such printed labeling with an electronic labeling system for the majority of prescription drugs. On several occasions Congress has directly declined to provide the FDA the necessary statutory authority to implement this change. As recently as 2012, Congress commissioned a GAO report (GAO-13-592) discussing this issue. The GAO report concluded that such a change could adversely impact public health. Thus, the Committee is very concerned that the FDA is moving to promulgate a regulation that would generally eliminate printed prescribing information inserts for prescription drugs. Therefore, the Committee has included a provision prohibiting the FDA from utilizing any funds to propose or otherwise promulgate any rule that requires or permits any prescription drug or biologic products to be distributed without printed prescribing information on or within the packaging from which such products are to be dispensed, unless such actions are expressly provided by an amendment to the FDCA.
Scientific Integrity. – Pursuant to the President’s 2009 memorandum and as directed by the Office of Science and Technology Policy, the FDA adopted a scientific integrity policy in 2012. It appears to conform to the President's directive by maintaining a firm commitment to science-based, data-driven decision making, facilitating the free flow of scientific and technical information, and requiring a fair and transparent approach to resolving scientific disputes. The Committee directs the Commissioner to ensure all FDA centers agencies are complying with the policy and using it to guide their policy and regulatory decisions.
Scientific Study Data. – Sound science, peer review and transparency are essential to effective protection of public health. The Committee is concerned that data from scientific studies utilized in forming public policy may not be available for public review, even under Freedom of Information Act requests. The Committee believes that if public policy is based on a scientific study, that study should be available for public review. The Committee urges the FDA to immediately provide, on its website, the data and studies it uses to support public policy used by the FDA or other Federal agencies based on FDA studies.
Sodium Intake Levels. –The Committee is concerned about the FDA’s continued focus on voluntary sodium reductions and recommendations to remove the GRAS status of sodium given the growing body of evidence that suggests low sodium consumption can lead to health problems in healthy individuals [(see our previous post here)]. The Committee requires the FDA, in coordination with CDC, to convene a panel at the IOM to determine the blood pressure effect and Cardiovascular Disease (CVD) implications for healthy people consuming sodium at 3000 mg or less per day. Federal funds should not be expended on sodium reduction activities below 3000 mg per day until the science is formally considered surrounding healthy and safe sodium intake, especially for healthy individuals, and the impact of lower sodium on blood pressure (and an extrapolation to health), including direct research suggesting a negative impact of lower sodium on health.
Spent Grains. – The Committee recognizes that the FDA took into consideration public comments and revised some of its proposed regulations on spent grains used for animal food. Processors already complying with FDA human food safety requirements would not need to implement additional preventive controls when supplying a by-product like wet spent grains for animal food. However, further processing a by-product for use as animal food such as drying spent grains, would require additional compliance under the proposed rule. The FDA has said potential hazards associated with spent grains are minimal, and steps to prevent contamination are likely already in place. The Committee includes bill language to ensure dry and wet spent grains used for animal food are regulated equally.
Sunscreen Ingredient Applications. – The Committee is concerned that another year has passed without the FDA completing its review of the pending Time and Extent Applications (TEAs) and the OTC Monograph rulemakings on sunscreens. Immediate action on sunscreen applications should be a priority since the need for sunscreens is evident by the nearly five million people that are treated annually for all skin cancers and the fact that melanoma is the fifth leading cause of cancer in the U.S. this year. The bill provides the requested funding of $700,000 for the FDA to complete timely reviews of filed requests and determine the safety and efficacy of sunscreen ingredients.
Sunscreen Ingredients and Report. – Thirteen years have passed without FDA final decisions on sunscreen ingredients that have been used around the world for many years. FDA's inaction is particularly concerning because bipartisan reforms were enacted in the Sunscreen Innovation Act (SIA) addressing all of the issues identified as impediments by the FDA [(see our previous post here)]. The Surgeon General called on the Federal government to work with stakeholders to support skin cancer prevention and yet the FDA has still not approved a new sunscreen product since the 1990s.
The FDA shall produce a report to the Committee by September 1, 2015, that contains a detailed analysis of how the FDA is balancing the Surgeon General's Call to Action, the known public health benefits that regular sunscreen use provides to prevent skin cancer and melanoma, and the long history of safe and effective use of sunscreens currently backlogged at the FDA in comparable countries versus the hypothetical risk sunscreens posed to human health in FDA’s GRAS standard. Furthermore, the FDA shall issue draft guidance for industry outlining data required for sunscreen active ingredients to meet the FDA’s safety and efficacy standards and meet SIA's statutory deadlines for publication. The bill provides $700,000 for FDA's sunscreen activities.
Surrogate Endpoints. – The Committee urges the FDA to issue guidance on the use of surrogate and intermediate endpoints for accelerated approval of regenerative medicine products under section 506(c) of the FDCA (21 U.S.C. 356(c)). In the process of issuing guidance, the FDA shall consult with appropriate stakeholders in the development of this guidance.
Tobacco Product Regulation. – The Committee includes bill language making a technical change to the FDA's regulation of newly deemed tobacco products and products with nicotine derived from tobacco under the Tobacco Control Act (TCA). Current law allows the agency to regulate these newly deemed products, and this language maintains the FDA's authority to ensure their safety through the regulatory process. Notably, the TCA provides the FDA with the authority to require that manufacturers submit detailed product formulas to the FDA for each of their products; authority to review any modifications to these newly regulated products going forward; and authority to issue product standards and other enforcement tools, including misbranding, adulteration and post market surveillance. The Committee fully supports these efforts to reduce potentially harmful effects associated with tobacco products. The Committee also supports FDA efforts to subject certain tobacco products to additional provisions, including minimum age of purchase restrictions, health warnings for product packages and ads, and a prohibition of certain vending machine sales.
Rather than amending the FDA's regulatory authority, this language relates only to a specific date–the predicate date of February 15, 2007. The current predicate date was established arbitrarily with the passage of TCA: Congress determined that manufacturers would not have to submit a pre-market approval application to the FDA for tobacco products that already existed on the market at that time. Those products that came onto the marketplace during the transition period after February 15, 2007 but before June 22, 2009 and introduced 21 months after the law was enacted were permitted to stay on the market as long as the manufacturer submitted a substantial equivalence submission to the FDA before the end of this transition period. Products entering the marketplace after this time period are required to submit a premarket tobacco product application. Using the 2007 date means that newly-regulated categories of tobacco products–some of which have the potential to play an important role in harm reduction, and some of which hardly existed in commerce before that date–would face a more onerous approval process than cigarettes.
On April 25, 2014, the FDA released a proposed deeming regulation, which would grant authority for the agency to regulate cigars, vapor products and other products with nicotine derived from tobacco. The Committee hopes that the FDA finalizes that rule as soon as possible and urges the FDA to develop tobacco product safety standards aimed at reducing or eliminating the most harmful constituents for the safety of our public health, with a special focus on protecting young populations. Manufacturers should have to meet these product standards in order to ensure the safe sale of tobacco products in the marketplace. In particular, the Committee urges the FDA to further the extension of the TCA's national minimum purchase age of 18 years to all tobacco products, regardless of when all other aspects of the deeming rule are made final. Further, the Committee urges the FDA to make child-resistant packaging and warning labels mandatory for liquids used with electronic-cigarette vaporizers.
The Committee believes the FDA has discretion to modify the predicate date for these newly deemed products, but the FDA states that it would maintain February 15, 2007 as the predicate date. The Committee is concerned that this approach will dramatically add to the FDA’s substantial backlog of currently pending applications and create a regulatory logjam for the agency--diverting its attention from its core mission to promote public health, ensure the safe use of these products and prevent underage use and abuse. The Committee has therefore established a new policy that treats newly deemed products in the same way as the TCA treated newly regulated products when the law was enacted. Specifically, the language in this bill would make the predicate date for newly deemed tobacco products the effective date of the final deeming rule and mimic the 21-month transition period provided for cigarettes, smokeless tobacco and roll-your-own tobacco.
For those products that enter the marketplace after the new predicate date, it is the Committee's recommendation that the FDA provide education to manufacturers on how to complete Premarket Tobacco Applications and Substantial Equivalence Reports for newly deemed products. This education could take the form of guidance, webinars, and/or individual meetings with companies. Such outreach and educational efforts are especially important for small companies manufacturing products that have not been previously regulated by the FDA. Lastly, the Committee would support the FDA if the agency distinguished between premium cigars and other tobacco products in regulation. Premium cigars have consistently been shown to be less harmful and addictive, and are distinct from other tobacco products in regards to the perception among youth.
User Fee Collections/Obligations. – The Committee continues to be concerned about the financial management of the FDA’s user fee programs. The Committee directs that not later than 30 days after enactment of this Act, and each month thereafter through the months covered by this Act, the Commissioner to submit to the Committees on Appropriations of the House and Senate a report on user fees collected for each user fee program included in the Act. The report shall also include monthly obligations incurred against such fee collections. The first report shall include a distinct categorization of the user fee balances that are being carried forward into fiscal year 2017 for each user fee account as well as a detailed explanation of what accounts for the balance and what the balance will be used for.
Senate Fiscal Year 2016 FDA Appropriations Bill (S. 1800) & Report (S. Rept. 114-82)
The following provisions are included as “General Provisions” in Title VII of S. 1800:
Active Pharmaceutical Ingredients. – The Committee is concerned that the FDA has not yet approved a list of active pharmaceutical ingredients [APIs] for use by compounding pharmacists pursuant to the Federal Food, Drug, and Cosmetic Act [FDCA]. Within 90 days of the enactment of this act, the FDA is directed to provide a timeline for when the remaining substances will be considered, and in the meantime re-consider its policy with regard to enforcement of the bulk drug substances provisions under section 503A.
Alcohol Based Hand Sanitizers. – The Committee strongly supports the systematic review of healthcare antiseptic active ingredients used in alcohol based hand sanitizers [ABHS] products marketed under the over-the-counter [OTC] monograph to ensure the safety of healthcare workers and consumers, but is concerned about the potential impacts to public health that could occur if ABHS products containing healthcare antiseptic active ingredients are reclassified in a final monograph without full review of available, appropriate science based data and risk models. The FDA is requested not to issue a final monograph regarding OTC healthcare antiseptic active ingredients that are used in ABHS products, until full and fair consideration is given to existing evidence that has been provided to FDA that supports general recognition of safety and effectiveness of OTC ABHS products, and to potential costs associated with the final monograph.
Biosimilars. – The Committee is concerned that FDA has failed to provide the public adequate opportunity to review and comment on regulatory standards for the approval and oversight of biosimilar drugs. Therefore, FDA is directed to provide the Committee with an estimated timeline by which the agency will: finalize all pending draft biosimilars guidance documents, publish draft biosimilar guidance documents included in its 2015 regulatory agenda, and finalize those draft guidance documents. The Committee expects to receive this report no later than 2 weeks after the Committee reports this legislation.
Centers of Excellence in Regulatory Science and Innovation. – The Committee is encouraged by the ongoing research and collaboration underway at the Centers of Excellence in Regulatory Science and Innovation program and commends the FDA for launching this program in 2011 and expanding it in 2014. As such, the Committee directs the Office of the Commissioner to use at least $2,000,000 within existing funds to provide additional funding opportunities for the existing CERSI Centers to allow for the capitalization of ongoing studies and research.
Comparative Oncology. – The Committee recognizes the value in using data from cancers in companion animals to provide answers to important translational questions about cancer biology, diagnosis, and treatment. This research offers an important opportunity to study cancers in thousands of subjects to benefit both human patients and pets. The Committee requests FDA address the use of companion animals in diagnosis and treatment research and encourage the FDA to open grant opportunities in animal models to increase the study of the 1 million companion animals that naturally develop cancer each year.
Cord Blood Regulation. – The Committee directs the FDA to undergo a review and seriously consider the potential need for revision of the current regulatory requirements for cord blood licensure, particularly those related to manufacturing and storage, to ensure the correct applicability to this industry since the current regulatory requirements being applied are the same ones that apply to pharmaceutical products. In addition, the Committee directs the FDA to create an advisory task force, comprised at a minimum of public and private cord blood bankers, transplanters and patients, to provide recommendations to the agency about the current licensing requirements and changes that may be necessary.
Cosmetics. – The Committee provides not less than $11,700,000 for cosmetics activities, including not less than $7,200,000 for the Office of Colors and Cosmetics [OCAC]. Funding for OCAC is for the direct support of the operation, staffing, compliance, research and international activities performed by this office. The Committee notes that FDA’s budget submission stated that FDA would meet a March 2015 deadline, set by this Committee, to respond to a citizen petition regarding trace amounts of lead in cosmetics. This has not occurred, and this unacceptable delay is indicative of longstanding issues with FDA's review of cosmetics. Since 1976, cosmetic ingredients have been reviewed by a private Cosmetic Ingredient Review program, established by the cosmetic industry, with nonvoting FDA participation. The Committee directs FDA to work with the industry to study the transfer of this program to a more formal public-private partnership, similar to the United States Pharmacopeia, if appropriate and beneficial for consumers, and to report back to the Committee on this effort.
Deeming Regulations. – The Committee notes that the Family Smoking and Prevention and Tobacco Control Act, which became law in 2009, gave FDA immediate authority over certain tobacco products, and gave authority to the Secretary of Health and Human Services to deem other products subject to FDA regulation. On April 25, 2014, nearly 5 years after it had been granted the authority to do so, FDA issued those proposed deeming regulations, but has not yet finalized them. FDA is therefore directed to issue a final regulation addressing the deeming of other tobacco products under FDA's jurisdiction within 30 days and to act expediently to implement that regulation once finalized.
Drug Shortages. – The Committee is very concerned about continuing drug shortages, and the serious effects they can have on patients, including children. The Committee directs the Food and Drug Administration to report to the Committee on the work of FDA's intra-agency Drug Shortages Task Force. This report should include which offices and centers are represented on the task force, and how it works with other government agencies and outside stakeholders to address drug shortages. The report should also specify what activities the Task Force has undertaken to prevent drug shortages affecting pediatric patients, including working with outside experts on this issue.
Duchenne Muscular Dystrophy. – The Committee is aware that a patient-focused draft guidance for drug development on Duchenne Muscular Dystrophy was submitted to FDA in June 2014. The Committee supports this initiative and requests that FDA provide a detailed description of its plans to move forward with the development of a related guidance.
Farm Regulations. – The Committee remains concerned about how the FDA will determine whether and to what degree a farm or food business is subject to regulation. It is important that FDA is careful to apply new rules appropriately for the size of the operation in accordance with congressional intent.
Foreign High Risk Inspections. – As the importation of drugs, food, and medical devices from China continue to increase, the Committee is concerned about the FDA’s ability to keep pace with the exporter universe and volume of exports. For fiscal year 2015, an additional $2,000,000 was provided for foreign drug safety to address the growing number of human drugs produced overseas and the increasing number of imported drug shipments in order to ensure the continued safety and quality of these products. These funds have been provided to support the agency's overseas inspections, work with industry and other stakeholders in safety in manufacturing, strengthen agency relationships with foreign regulators, and analyze trends and events that might affect the safety of FDA-regulated products exported to the United States.
The Committee is supportive of FDA as it moves toward a more, targeted, risk-based, and efficient inspection model that incorporates commercially available information on high-risk establishments. As with other Federal agencies, such as CMS, better data has helped to make sure a company exists and is in good standing prior to an inspection and to help prioritize FDA's investigations and triage safety inspections. Within the funds provided for the China Safety Initiative the Committee directs the FDA to maintain robust funding for onsite verification support and integration of results in FDA inspection planning.
In Silico Clinical Trials. – In Silico clinical trials use computer models and simulations to develop and assess devices and drugs, including their potential risk to the public, before being tested in live clinical trials. Advanced computer modeling may also prove useful in helping to predict how a drug or device will behave when deployed in the general population or when used in particular circumstances, thereby helping to protect the public from the unintended consequences of side effects and drug interactions. In Silico trials may potentially protect public health, advance personalized treatment, and be executed quickly and for a fraction of the cost of a full scale live trial. The FDA has advocated the use of such systems as an additional innovative research tool. Therefore, the Committee urges FDA to engage with device and drug sponsors to explore greater use, where appropriate, of In Silico trials for advancing new devices and drug therapy applications.
In Vitro Clinical Trials. – In Vitro clinical trials use specimens collected from patients to test how a particular cancer or disease will react to a specific therapy or combination of therapies. This personalized approach to treatment can improve a patient’s quality of life by increasing the likelihood that physicians and researchers will find the proper combination of drugs uniquely suited to treat that individual’s illness. An emerging new scientific methodology, In Vitro trials allow researchers to test therapeutics and treatment strategies on living human tissues without the risks posed by traditional whole patient clinical trials. Personalized treatment through In Vitro trials dismantles the “one size fits all” approach to care and enables medical professionals to diagnose and treat patients in a more efficient and effective way. While the Committee recognizes that In Vitro tests may not always predict clinical responses, it urges the FDA to continue to engage with drug sponsors to explore greater use, where appropriate, of In Vitro clinical trials for drug development programs under Investigational New Drug applications and general therapeutic indications, especially as it relates to complicated cancers and other common disease states.
Mammography Quality Standards Act. – The Committee recommendation includes full funding as requested for implementation of the Mammography Quality Standards Act. This program sets national quality standards for mammography facilities, equipment, personnel and operating procedures, and has improved the quality of mammography and made mammograms a more reliable tool to detect breast cancers.
Mammography Reports. – The Food and Drug Administration is directed to revise its regulations regarding the summary mammography reports in lay language provided to patients to require the inclusion of information on the patient's breast tissue density; an explanation that dense tissue may mask the presence of breast cancer on mammograms; and advice that patients speak with their healthcare provider about whether they would benefit from additional tests, and about any other questions they may have. The FDA should also revise its regulations regarding the medical report provided to healthcare providers to require the inclusion of information on the patient's breast density and the masking effect such tissue may have on detecting breast cancer.
Master Plan. – The Committee has included $3,000,000 for FDA to complete a feasibility study to update and issue a revised Master Plan for the White Oak campus in order to address its expanded workforce and the facilities needed to accommodate them. The Committee directs FDA to report on this effort by January 1, 2016.
Medical Gases. – The Committee is concerned that FDA has not initiated rulemaking to address numerous longstanding regulatory issues for medical gases despite the statutory requirement in FDASIA to issue a final rulemaking addressing all necessary changes for medical gases by July 9, 2016. Designated medical gases are a unique class of drugs that differ significantly from traditional pharmaceuticals and therefore must be addressed in the Federal drug regulations to prevent safety and enforcement issues caused by current regulations. The Committee disagrees with the FDA report to Congress sent on June 30, 2015 that despite decades of issues created by existing regulations “the current regulatory framework is adequate and sufficiently flexible to appropriately regulate medical gases.”
Nanotechnology. – The Committee recognizes the increased capabilities that FDA has developed to study environment, health, and safety of nanomaterials within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The Committee expects FDA to continue to support collaborative research with universities and industry on the toxicology of nanotechnology products and processes in accordance with the National Nanotechnology Initiative Environment, Health, and Safety Research Strategy as updated in October 2011.
National Antimicrobial Resistance Monitoring System. – The Committee recommendation includes $10,800,000 for the National Antimicrobial Resistance Monitoring System, equal to the level provided in fiscal year 2015.
Nutrition Facts Label. – The Committee is concerned that the FDA has not published in the Federal Register the results of FDA’s “Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars” (78 FR 32394, May 30, 2013). The purpose of the study, as described by the Agency, is “to examine how consumers would comprehend and use this new information”. Given that sound science, peer review and transparency are essential to effective protection of public health, the Committee encourages the FDA to release this study for public review and comment prior to finalizing changes to the Nutrition Facts label.
Opioid Overdose Prevention. – The Committee notes that on June 15, 2015, the CDC issued a report on “Opioid Overdose Prevention Programs Providing Naloxone to Laypersons”, in which the CDC noted the benefits of expanding access to the life-saving drug naloxone, which reverses the effects of an opioid overdose. The Committee urges FDA to promote the development and widespread usage of naloxone products. The agency’s efforts should include working closely with product sponsors interested in marketing naloxone for use without a prescription to expedite review and decisionmaking.
Oversight Activities. – The Committee notes that over the past 5 years FDA’s responsibilities and resources have grown significantly. The Committee is concerned that oversight of FDA has not kept pace with the growth in the agency's regulatory authority or funding. Therefore, the Committee recommendation includes $1,500,000 for the HHS Office of Inspector General specifically for oversight of FDA activities. The funding provided under this appropriation is in addition to FDA oversight activities supported within the Inspector General’s regular appropriation. The Committee instructs the Inspector General to submit a plan, within 60 days of the enactment of this act, on the additional oversight activities planned with this funding.
Pediatric Device Consortia Grants. – The Committee is pleased that the nine FDA-funded Pediatric Device Consortia have assisted in the development of more than 450 proposed pediatric medical devices since its inception in 2009, as well as promoting job-growth in the healthcare sector, and as such, continues to support this critical effort. The program funds consortia to assist innovators in developing medical and surgical devices designed for the unique needs of children that often go unmet by devices currently available on the market. The Committee directs FDA to fund this program at the highest possible level within available resources, and at no less than the level funded in the previous year.
Repackaging for Long Term Care Pharmacies. – In February the Food and Drug Administration released a draft guidance entitled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” The Committee is concerned that in issuing the draft guidance the agency failed to consider the unique nature of long term care pharmacies and the populations they serve. Before issuing a final guidance the Committee urges the agency to consider its implications on patient access to safe and effective medications from long term care pharmacies.
Seafood Advisory. – The Committee remains concerned that despite numerous commitments over many years, FDA has not published final advice on seafood consumption for pregnant women, mothers, and children. The Committee is pleased that FDA released draft advice in June 2014, however, pregnant women and healthcare providers still await clear, actionable and science-based final seafood advice. Based on the recommendation of the Dietary Guidelines Advisory Committee, the final FDA seafood advice shall re-evaluate the draft limit on albacore tuna to ensure it is consistent with the FDA net effects report and the Joint United Nations Food and Agriculture Organization/World Health Organization Expert Consultation on the Risks and Benefits of Fish Consumption, 2010. The Committee directs FDA to publish final advice to pregnant women on seafood consumption in conjunction with all applicable parties. Finally, FDA shall provide a progress report to the Committee 30 days after the enactment of this act and every 30 days thereafter until the final seafood advice is published.
Seafood Economic Integrity. – The Committee recognizes the importance of seafood to a healthy diet, but is concerned that the FDA does not focus sufficient attention on economic integrity issues, particularly with respect to mislabeling of species, weights, and treatment. The Committee encourages the FDA to work with States and the Department of Commerce to more aggressively combat fraud in parts of the seafood industry.
Seafood List. – The Committee directs the Commissioner to expedite consideration of whether it is appropriate to change the acceptable market name of Gadus chalcogrammus (formerly classified as Theragra chalcogramma) from “Alaska Pollock” to “Pollock” in the Seafood List. It is critical that seafood nomenclature (acceptable market names) is science-based, truthful, and not misleading to the consumer.
Sodium. – The Committee is concerned about FDA's continued focus on voluntary sodium reductions and the Institute of Medicine’s [IOM] 2010 recommendation to modify the Generally Recognized as Safe [GRAS] status of sodium, particularly given the ongoing scientific discussion regarding appropriate sodium intake to maintain positive health. The IOM published a more recent study in 2013, which concluded additional research may provide further information with respect to the health effects of sodium intake on general and sub populations. The Committee recommends that a panel be convened, at the IOM or another leading Federal institution, which includes a representative array of research perspectives, including those who have raised concerns on the safety of low-sodium diets. The Committee does not believe any sodium reduction activities should be finalized until the disagreement between the impact of lower sodium on blood pressure (and an extrapolation to health) and direct research suggesting a negative impact of very low-sodium intakes is resolved.
Sunscreen. – The Committee is aware that in July 2014, the U.S. Surgeon General issued A Call to Action to Prevent Skin Cancer, concluding nearly 5 million people are treated annually for all skin cancers combined, with an estimated cost of $8,100,000,000 per year. As a result, the Surgeon General called on the Federal Government to work with stakeholders to support skin cancer prevention. The Committee is pleased with the bipartisan reforms enacted in the Sunscreen Innovation Act[SIA] in 2014 to improve the process by which the FDA reviews sunscreen ingredients; however, the Committee is concerned that while skin cancer rates in the United States continue to climb, no new sunscreen ingredients have been generally recognized as safe and effective [GRASE] by the FDA since passage of the SIA. The Committee directs the FDA to provide a report that contains a detailed analysis of how FDA is balancing the Surgeon General's Call to Action, the known public health benefits that regular sunscreen use provides to prevent skin cancer and melanoma, and the long history of safe and effective use of sunscreens in comparable countries versus the hypothetical risk sunscreens posed to human health in FDA’s generally recognized as safe and effective [GRASE] standard. Immediate action on sunscreen applications should be a priority.
In addition, the Committee directs the FDA to work with stakeholders to ensure consumers in the United States have access to all sunscreen products that have been shown to be safe and effective; and therefore, requests that FDA, in finalizing the sunscreen monograph consistent with the SIA, include provisions related to the maximum Sun Protection Factor [SPF] and to address spray dosage forms for sunscreens.
Vibrio. – The Committee is aware of the public health challenge related to the naturally occurring bacteria called Vibrio parahaemolyticus (V.p.) that can accumulate in shellfish and believes that more scientific research is necessary to developing proper controls that will reduce the risk to consumers and sustain a healthy domestic shellfish industry. The Committee encourages the Food and Drug Administration [FDA] to increase funding for research into Vibrio illnesses associated with the consumption of raw molluscan shellfish, improve risk assessment models, and develop improved rapid detection methods for virulent Vibrio strains.
Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016,” would give FDA a small increase over Fiscal Year 2015 funding. In addition to funding FDA, however, the bills (S. 1800 and H.R. 3049) and their accompanying reports (H. Rept. 114-205 and S. Rept. 114-82) heap on various recommendations and directives. We’ve extracted those items from each of the documents and added some links to background information. We’re not going to get into all of the appropriations funding numbers. Instead, we’ll leave that to the folks over at the Alliance for a Stronger FDA, who have provided initial break-outs of both the Senate and House appropriations bills (here and here).
House Fiscal Year 2016 FDA Appropriations Bill (H.R. 3049) & Report (H. Rept. 114-205)
The following provisions are included as “General Provisions” in Title VII of H.R. 3049:
- Sec. 723. Not later than 30 days after the date of enactment of this Act, the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, the Chairman of the Commodity Futures Trading Commission, and the Chairman of the Farm Credit Administration shall submit to the Committees on Appropriations of both Houses of Congress a detailed spending plan by program, project, and activity for all the funds made available under this Act including appropriated user fees, as defined in the report accompanying this Act.
- Sec. 743. None of the funds made available by this Act may be used to propose, promulgate, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of in paper form) unless and until a Federal law is enacted to allow or require such distribution.
- Sec. 744. None of the funds made available by this Act may be used to implement, administer, or enforce the final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” published by the Food and Drug Administration in the Federal Register on December 1, 2014 (79 Fed. Reg. 71156 et seq.) until the later of—
(1) December 1, 2016; or
(2) the date that is one year after the date on which the Secretary of Health and Human Services publishes Level 1 guidance with respect to nutrition labeling of standard menu items in restaurants and similar retail food establishments in accordance with paragraphs (g)(1)(i), (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of section 10.115 of title 21, Code of Federal Regulations.
- Sec. 745. None of the funds made available by this Act may be used to review or approve an application for an exemption for investigational use of a drug or biological product under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)) in research in which a human embryo is intentionally created or modified to include a heritable genetic modification.
- Sec. 746. None of the funds made available by this or any other Act may be used to implement or enforce any provision of the FDA Food Safety Modernization Act (P.L. 111-353), including the amendments made thereby, with respect to the regulation of the distribution, sale, or receipt of dried spent grain byproducts of the alcoholic beverage production process, irrespective of whether such byproducts are solely intended for use as animal feed.
- Sec. 747. For each tobacco product which the Secretary of Health and Human Services, by regulation under section 901(b) of the Federal Food, Drug, and Cosmetic Act, deems to be subject to chapter IX of such Act, none of the funds made available in this Act or any other Act may be used to treat any reference in sections 905 and 910 of such Act to February 15, 2007, as other than a reference to the effective date of the regulation under which a tobacco product is deemed subject to the requirements of such Act pursuant to section 901(b)(1) of such Act, and any reference in such sections to 21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act as other than a reference to 21 months after the date of such final deeming regulation.
- Sec. 751. Not later than 30 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a notice in the Federal Register clarifying that until the compliance date specified in the order published by the Food and Drug Administration in the Federal Register on June 17, 2015 (80 Fed. Reg. 34650 et seq.), partially hydrogenated oils shall be considered generally regarded as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)).
- Sec. 752. Notwithstanding any other provision of law—
(1) the Secretary of Agriculture shall implement section 12106 of the Agricultural Act of 2014 and the amendments made by such section (21 U.S.C. 601 note; Public Law 113-79), including any regulation or guidance the Secretary of Agriculture issues to carry out such section or the amendments made by such section; and
(2) the Secretary of Health and Human Services shall implement section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)), including any regulation or guidance the Secretary of Health and Human Services issues to carry out such section.
The following provisions are included in H. Rept. 114-205:Funding for Food Safety. – The Committee includes increases of $41,500,000 for the implementation of the FSMA. These increases consist of: $18,500,000 for Inspection Modernization and Training; $5,000,000 for the National Integrated Food Safety System; $11,500,000 for Education and Technical Assistance for Industry; $2,500,000 for Technical Staffing and Guidance Development; $3,000,000 for Import Safety; and $1,000,000 for Risk Analytics and Evaluation. The increases provided in this bill and the increases provided since fiscal year 2011 should assist the FDA in preparation for the implementation of FSMA prior to the effective dates of the seven foundational proposed rules. While the FDA has not implemented the final rules, the Committee understands that most businesses will not need to comply with the two rules for preventive controls for human food and for animal food until August 2016 and that the other five rules will not be effective until fiscal year 2017 and later.
The Committee notes that with these increases, the estimated total funding for food safety since FSMA was signed into law on January 4, 2011, would be over $230 million. In addition to the increases for FSMA, the FDA utilizes base resources for its comprehensive food safety efforts. Prior to the Committee's investment in food safety activities related to FSMA over the past five years, FDA reported that it spent $785 million for food safety in fiscal year 2009 and had an appropriation for food safety of $952.9 million in fiscal year 2010. While some of these base resources prior to the enactment of FSMA covered statutory responsibilities that are not directly linked to FSMA, a large majority of such funds do relate to FSMA and should be accounted for accordingly. The Committee continues to seek far more information on how the agency is spending its resources for FSMA related activities from increased funding and base resources. Therefore, the Committee directs the FDA to provide a detailed accounting of its food safety resources in the fiscal year 2017 budget request, including which pre-2011 base resources are now repurposed for activities in support of FSMA and which resources are the result of appropriated increases from fiscal years 2011 to 2016, a detailed explanation of what the FDA has accomplished with increased food safety resources since fiscal year 2011, and how the aggregate total of these base resources for food safety will be utilized in fiscal year 2017.
Medical Product Safety Funding. – The Committee provides an increase of $4,216,000 for medical product safety initiatives. Included in this amount is $2,500,000 for combating antibiotic resistant bacteria as part of the National Strategy for Combating Antibiotic Resistant Bacteria (CARB), $1,000,000 for the Precision Medicine initiative, and $716,000 for the evaluation of over the counter sunscreen products. According to the FDA's fiscal year 2016 budget request, the Agency is spending approximately $32.5 million on antimicrobial resistance activities in fiscal year 2015. With this increase, the FDA is expected to spend approximately $35 million on combating antibiotic resistance in fiscal year 2016.
Active Pharmaceutical Ingredients. – The Committee is concerned that the FDA has not yet approved a list of Active Pharmaceutical Ingredients (APIs) for use by compounding pharmacists pursuant to the Drug Quality and Security Act (Public Law [113-54], 127 Stat. 587) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a et seq.). Within 90 days of enactment of this Act, the FDA shall report to Congress on when its review of proposed APIs pursuant to Sec. 503A(1)(a)(iii) will be completed.
Antibiotics. – The Committee urges the FDA to work to foster the development of new antibiotics by supporting greater collaboration between industry and the FDA around adaptive clinical trials and labeling changes. The President’s Council of Advisors on Science and Technology has recommended this proposal to help support the type of robust drug development that will be needed to ensure patients are protected from bacterial resistance.
Bioethics. – The Committee notes that the FDA commissioned a consensus study from the Institute of Medicine (IOM) on “Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases.” The Committee further notes that the FDA has requested that the IOM produce a consensus report on the ethical and social policy issues related to genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease. The Committee directs the FDA to establish an independent panel of experts, including those from faith-based institutions with expertise on bioethics and faith-based medical associations, and to submit this consensus report to the independent panel of experts upon its completion by the IOM. The Committee urges the independent panel of experts to review the IOM report and report their evaluation of its conclusions, along with any recommendations based on this review, to the Committee within 30 days of the completion of the report by the IOM.
Biological Products. – The Committee commends the FDA for issuing draft guidance to address the mixing, diluting, or repackaging of biological products outside the scope of an approved biologics license application. The Committee urges the FDA to finalize the guidance without delay following the public comment period and continues to emphasize the need for close FDA inspection and supervision of large-scale compounding and repackaging of sterile injectable drugs and biological products, particularly products that are administered into areas of the human body where there is tempered immunity, such as the eye or spinal column, to ensure that they are processed in keeping with current good manufacturing practice for sterile products, in particular 21 CFR 200.50 regarding ophthalmic preparations.
Biosimilars–Naming and Interchangeability – Five years post-enactment of the Biologics Price Competition and Innovation Act (BPCIA), FDA has only released guidances on general issues like scientific considerations in demonstrating biosimilarity, how exclusivity for innovator products may be applied, and how FDA will conduct industry/applicant meetings. These guidances do not address in any way the key considerations affecting patients or providers, such as what biosimilars will be named so that patients and their providers know which specific therapy a patient receives, for which indications can a biosimilar or interchangeable product be used, and scientific considerations for determining interchangeability. Due to the absence of these guidances the FDA was forced to approve biosimilar Zarxio with a “placeholder” name. The Committee finds this unacceptable and directs the FDA to issue naming and interchangeability guidances no later than November 30, 2015.
Blood Plasma Products. – The Committee notes that the FDA has followed the Committee's advice from fiscal year 2015 and is addressing the issue of the use of plasma for post-collection manufacture into critical plasma derivatives, no matter the manner in which the blood is collected. The Committee urges the FDA to prioritize developing policies to allow for the more timely use of plasma from automated donations into other biologics and asks that the FDA update the Committee on its progress with a report no later than 60 days after enactment of this Act.
Blood Product Policies. – Last December, the FDA released draft guidance for industry entitled “Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.” As the agency is aware, the Committee issued report language in fiscal year 2012 expressing concern for the safety risks to transfusion patients from bacterially contaminated platelets. The Committee is pleased to see the agency take the step of releasing draft guidance. Unfortunately, when the FDA released its guidance agenda for 2015, the final version of this draft guidance was not listed among the agency’s priorities. This is an important safety issue, and it is essential that the agency complete the guidance process in a timely manner. The Committee urges the FDA to do so as quickly as possible.
Centers of Excellence – The Committee is aware of the important contribution of CFSAN’s Food Safety Centers of Excellencein supporting critical basic research as well as facilitating the implementation of the Food Safety Modernization Act. The Committee encourages the agency to continue to fully utilize the Centers of Excellence to accomplish these goals and to enhance its level of support for Food Safety Modernization Act activities and to increase funding for base work.
Cord Blood Regulation. – The Committee directs the FDA to undergo a review and seriously consider the potential need for revision of the current regulatory requirements for cord blood licensure, particularly those related to manufacturing and storage, to ensure the correct applicability to this industry since the current regulatory requirements are the same ones that apply to pharmaceutical products. In addition, the Committee directs the FDA to create an advisory task force, comprised at a minimum of public and private cord blood bankers, transplanters and patients, to provide recommendations to the agency about the current licensing requirements and changes that may be necessary.
Cosmetics and Colors. – The Committee directs the FDA to spend no less than the fiscal year 2015 level for cosmetics activities as well as for the Office of Colors and Cosmetics (OCAC). Funding provided for OCAC is for direct support of the operation, staffing, compliance, research and international activities performed by this office.
The Committee notes that, for the past five years, it has directed the FDA to respond to the Citizen Petition requesting that the FDA establish a safe level for lead as a nonfunctional constituent in lipstick. The Committee is aware that in 1975 the cosmetic industry asked the FDA to evaluate the safety of ingredients found in its products. Consistent with this commitment, in 1976 the cosmetic industry established the Cosmetic Ingredient Review (CIR) under which the safety of approximately 3,880 ingredients has been reviewed by an Expert Panel of independent scientists, and the FDA has participated through a nonvoting liaison at all meetings of the Expert Panel. The Committee directs the FDA to respond to the Citizen Petition on this lipstick ingredient by December 31, 2015.
Cosmetic Ingredient Review Panel. – As noted, the cosmetic industry established the CIR as a means to assure the safety of ingredients in cosmetic products. Given the breadth and volume of ingredients reviewed and the scientific expertise applied to its process, it is the Committee's belief CIR should be recognized and formalized as a public-private program. The Committee therefore directs that the FDA work with the cosmetic industry to transfer the CIR to the United States Pharmacopeia Convention (USP) or some other appropriate third body for the purpose of evaluating and determining the safety of ingredients found in cosmetics. USP is a widely respected independent scientific organization whose drug standards are explicitly incorporated under the Federal Food, Drug, and Cosmetic Act (FDCA). The Committee directs that the FDA, working cooperatively with the cosmetic industry, report back to the Committee no later than January 15, 2016, with a framework and a detailed plan.
Drug Compounding. – The Committee is concerned that, since passage of the Drug Quality and Security Act (DQSA) of 2013, the FDA has interpreted provisions of Section 503A of the FDCA in a manner inconsistent with its legislative intent and with the agency’s own previous positions. Specifically, the FDA has taken the position that under 503A, a pharmacist may not compound medications prior to receipt of a prescription and transfer the drugs to a requesting physician or other authorized agent of the prescriber for administration to his or her patients without a patient-specific prescription accompanying the medication. This practice, which is often referred to as “office-use” compounding [(see our previous post here)], is authorized in the vast majority of states and was intended to be allowable under DQSA. The Committee is aware that in 2012, prior to passage of the DQSA, FDA was working on a draft compliance policy guide for 503A of the FDCA that provided guidance on how “office-use” compounding could be done consistent with the provisions of 503A. The Committee understands the intent of the DQSA was not to prohibit compounding pharmacists from operation under existing 503A exemptions; therefore, the Committee directs the FDA to issue a guidance document on how compounding pharmacists can continue to engage in “office-use” compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A within 90 days after the enactment of this Act.
Drug Labeling Approval. – The Committee acknowledges FDA's actions over the past six months regarding the proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” to include a listening session on March 27, 2015, and a reopened comment period that closed on April 27, 2015. However, the Committee continues to be concerned with FDA actions from the beginning of this process and the subsequent failure to find closure on this issue. As things currently stand, the rule would allow a generic drug manufacturer to alter its safety labeling unilaterally without FDA’s prior approval, even if there is more than one generic manufacturer or an innovator manufacturer and generic manufacturer marketing the same bioequivalent drug (a “multisource” drug), and other companies are not required to make a corresponding labeling change.
The proposed rule has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for bioequivalent products. The Committee urges the FDA to finalize the rule based upon comments it received in the docket and during the March 27 public meeting to meet the stated objectives of ensuring that patients have the most complete and up-to-date information regarding their prescription drugs. The final rule should establish: (1) FDA as the final decision maker of whether or not a manufacturer should change its labeling in a multisource environment; (2) a process by which the FDA collects and utilizes all safety information to determine if a labeling change is required–from the new safety information from the manufacturer to sources such as the Sentinel System and other global databases; (3) a process by which the FDA has defined time parameters to take action on new safety information provided by innovator or generic application holders; and, (4) a process by which manufacturers should have a defined time period to make the corresponding labeling change. A final rule with these minimum requirements should be grounded in scientific evidence, and present no opportunity for mismatched dispensing or use information between the innovator drug and the generic version drug.
Drug Shortages. – The Committee is aware that shortages of critical drugs persist following the 2012 enactment of the Food and Drug [Administration] Safety and Innovation Act (FDASIA). Surveys conducted by the American Association of Nurse Anesthetists, the American Hospital Association, and the American Society of Health-System Pharmacists report persistent shortages of drugs used in anesthesia care, oncology, and other services, owing primarily to problems in manufacturing, which impair patient access to care and patient experiences in the healthcare system, delay surgical procedures, and possibly increase overall healthcare costs. Therefore, within the funding provided the Committee directs the Commissioner to continue to prioritize the public reporting of manufacturing shortages, and to work with industry to prevent conditions that might lead to drug shortages.
The Committee remains concerned about national shortages of drugs to test for and treat Tuberculosis (TB), and recognizes that shortages could lead to further TB transmission as well as the development of drug resistance. The FDA is encouraged to ensure that TB control partners are participating in the Drug Shortages Interagency Task Force, including representatives of the Centers for Disease Control and Prevention, the Office of Emergency Preparedness and Response, and the Federal TB Task Force. The Committee requests a report on steps the FDA can take to prevent TB drug shortages and help maintain an adequate supply.
Duchenne Muscular Dystrophy. – The Committee is aware that the FDA recently released draft guidance for the development of drugs to treat Duchenne Muscular Dystrophy and related issues. The Committee commends FDA for working with patient groups and urges them to continue this collaborative approach when evaluating the medical needs of a rare disease community.
FDA Partnerships Under FSMA. – The purpose of FSMA is to reform the nation's food safety laws to ensure a safe public food supply. As the FDA continues implementation of FSMA, the Committee encourages the FDA to work in partnership with existing government food safety programs, including the use of MOUs, to verify compliance with FSMA rules once they are finalized as a way to eliminate duplication of activities under the law. In addition, the Committee provides an increase of $2.5 million for the Food Safety Outreach Program under NIFA, and expects that, per the proposal in the President’s fiscal year 2016 budget request, NIFA will serve as the sole agency providing food safety training, education, outreach, and technical assistance at the farm level.
Food Contact Notification User Fees. – The funds made available by this Act include sufficient monies to fund the FDA’sFood Contact Notification Program and shall be deemed to satisfy the requirements of 21 U.S.C. 348(h)(5)(A). The Committee recommendation does not include proposed user fees.
Generic Drug User Fee Facility Fees. – When the FDA begins the process for GDUFA reauthorization negotiations on June 15, 2015, the Committee urges all stakeholders to carefully consider providing fee waivers, exemptions, or otherwise reduced fees for small generic drug manufacturers to minimize the disproportionate financial burden on these companies.
Genomic Editing. – The Committee understands the potential benefits to society in the genetic modification of living organisms. However, researchers do not yet fully understand all the possible side effects of editing the genes of a human embryo. Editing of the human germ line may involve serious and unquantifiable safety and ethical issues. Federal and non-Federal organizations such as the National Academy of Sciences and National Academy of Medicine will soon engage in more extensive scientific analysis of the potential risks of genome editing and a broader public discussion of the societal and ethical implications of this technique. In accordance with the current policy at the National Institutes of Health, the Committee includes bill language that places a prohibition on the FDA’s use of funds involving the genetic modification of a human embryo. The Committee continues to support a wide range of innovations in biomedical research, but will do so in a fashion that reflects well-established scientific and ethical principles.
Harm Reduction. – It is the Committee recommendation that the FDA consider the benefits of harm reduction as part of evaluations under the Deeming regulations for tobacco products.
Imported Pet Food Product Transparency. – As of May 15, 2015, the FDA had received approximately 5,200 reports of pet illness related to consumption of jerky pet treats, nearly all of which are imported from China. The reports involve more than 6,000 dogs, 26 cats, and 3 humans and include more than 1,100 canine deaths. These incidents date back to 2007. The Committee requests that the FDA provide it with a summary of all activities associated with the investigation into the pet illnesses associated these products, including any import alerts and import refusals, within 60 days of the enactment of this Act. In addition, the Committee requests that the agency provide it with semi-annual reports on the status of the investigation into these illnesses beginning in April 2016 until the issue has been resolved.
Late Reports. – The Committee reminds the Commissioner that the timelines specified by the Committees on Appropriations of the House and Senate for fiscal year 2015 reports are deadlines that must be met. While the Committee notes that the FDA has made progress in providing more timely information and updates, the FDA still has several outstanding reports that are delayed due to long reviews and clearances. The Committee directs the Commissioner to submit these overdue reports. [(See our previous post here.)]
Local Port Cooperation – The Committee directs FDA to work with local governments at high volume ports of entry to explore activities which reduce the risk of food borne llnesses and enhance the capacity of local officials in dealing with food borne threats.
Mammography Quality Assurance Advisory Committee. – More than three years ago, in November 2011, theNational Mammography Quality Assurance Advisory Committee approved a change to the mammogram patient report and physician report to include information regarding an individual’s breast density. This process has not been completed. The Committee urges the FDA to implement this change in an expedited manner and must report to Congress on the status of this change no more than 60 days from the enactment of this Act.
Medical Countermeasures. – The Committee directs that not less than $24,552,000 shall be available for the FDA’sMedical Countermeasures Initiative. This total is in addition to the unobligated funds remaining to support the FDA’s emergency response to Ebola and related disease outbreaks.
Medical Gas Rulemaking. – The Committee is concerned that the FDA has not initiated rulemaking to address numerous longstanding regulatory issues for medical gases despite the statutory requirement in FDASIA to issue a final rulemaking addressing all necessary changes for medical gases by July 9, 2016. Designated medical gases are a unique class of drugs that differ significantly from traditional pharmaceuticals and therefore must be addressed in the Federal drug regulations to prevent safety and enforcement issues caused by current regulations. The FDA has never responded to a 1979 Citizens Petition on expiration dating or a 1994 Citizens Petition on calculation of yield, and has not responded to a January 2014 statutorily required report on medical gas regulatory review. Therefore, the FDA shall issue a proposed rulemaking to address each and every regulatory issue that creates safety and enforcement issues for medical gases by September 30, 2015.
Menu Labeling. – The Committee is concerned about recent FDA final determination that increased the size and scope of those affected under restaurant menu labeling regulations. Specifically, the final rule attempts to regulate local grocery chains that typically do not qualify as restaurants. These newly regulated entities do not have clear guidance from the FDA as to how they must comply with numerous provisions of the final regulation. The Committee includes bill language that directs the FDA to implement the final rule no earlier than December 1, 2016, and at least one-year following agency publication of related guidance to newly regulated stakeholders. [(See our previous post here.)]
Molluscan Shellfish – The Committee is concerned that non-tariff trade barriers continue to preclude trade in molluscan shellfish with European Union states. The Committee encourages the agency to expedite its audit of growing areas in Europe and to seek equivalency in sanitary standards where possible to allow a resumption of trade.
Off-Label Guidance. – The Committee notes that in December of 2011, the FDA issued “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices”, and a request for comment to assist the agency in evaluating policies for off-label uses of both approved and investigational drugs and devices. The comment period closed on March 27, 2012. Further, the FDA responded in June 2014 to two citizen petitions that were submitted to the agency in July of 2011 and September of 2013 requesting clarification of regulations and policies regarding certain communications related to investigational new drugs and investigational new devices and off-label uses of drugs and devices. In the FDA’s response, the agency stated, “that it plans to issue guidance that addresses unsolicited requests, distributing scientific and medical information on unapproved new uses and manufacturer discussions regarding scientific information more generally, by the end of the calendar year.”
The Committee is concerned that the FDA has yet to issue new guidelines regarding the manner in which truthful and non-misleading scientific information outside of a product label for prescription drugs and medical devices can be conveyed. The Committee directs the FDA to address this issue comprehensively, outlining how manufacturers can communicate with all healthcare stakeholders, and to complete such guidelines within 60 days of enactment of this Act.
Over the Counter (OTC) Medicines for Children – The Committee is concerned that the FDA has not issued a proposed rule revising the monograph regulating the labeling of OTC cough and cold products for children. The Committee directs the agency to publish a proposed rule by November 30, 2015, based on scientific evidence for safety and efficacy in pediatric populations and taking into consideration the October 19, 2007 joint recommendations of its Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee. While the Committee appreciates the agency's effort to explore possible improvements to the OTC drug monograph process; these efforts should not impede the prompt publication of this proposed rule.
Partially Hydrogenated Oils. – The Committee is concerned that the FDA’s recent final determination that partially hydrogenated oils (PHOs) are no longer Generally Recognized as Safe (GRAS) could cause economic disruption in the marketplace and lead to unnecessary litigation [(see our previou spost here)]. More importantly, the FDA should clarify that they have not concluded that PHOs are unsafe but that they no longer meet the general recognition element of the GRAS standard. Further, it is disturbing that the FDA would make such a determination without full public documentation of the data and process used to do so. Therefore, the Committee directs the FDA, in carrying out its enforcement of this determination, to: 1) issue a notice that it will delay the effective date of the final determination until acting on a Food Additive Petition following the procedures identified in 21 C.F.R. 170 38(c); 2) provide a reasonable transition period of 3 years for companies to reformulate products that would allow the marketing of current uses of PHOs during this transition period; 3) clarify that the final determination applies prospectively and after the agency issues the food additive regulation; and (4) that the FDA clarify that products containing PHOs prior to and during this transition period be deemed lawful and in compliance with the FDCA, and not seek to enforce any ban on the introduction of PHOs into commerce until after the revised effective date.
Pharmacy Compounding. – The Committee is very concerned with the draft MOU that the FDA has proposed under Section 503A of the FDCA [(see our previous post here)]. The proposed MOU would complicate patient and prescriber access to compounded medications, and may have a deleterious effect on small pharmacies. Under the draft MOU, the FDA attempts to describe “distribution” as occurring when “a compounded human drug product has left the facility in which the drug was compounded.” In the DQSA, Congress only allowed the FDA to regulate “distribution.” But the MOU appears to exceed the authority granted in the statue by redefining “distribution'' in a manner that includes dispensing–something unprecedented. This overreach could generate exactly the kind of costly and confusing litigation that Congress intended to avoid when it amended and reinstated Section 503A. The Committee expects that, when a final MOU is proposed as a model agreement for the states to consider, that distribution and dispensing are treated as the different and separate activities that they actually are.
Pollock Nomenclature. – The Committee directs the Commissioner to expedite consideration of whether it is appropriate to change the acceptable market name of Gadus chalcogrammus (formerly classified as Theragra chalcogramma) from “Alaska Pollock” to “Pollock” in the Seafood List. It is critical that seafood nomenclature (acceptable market names) is science-based, truthful, and not misleading to the consumer.
Prescription Drug Labeling Inserts. – The Committee is aware of FDA proposals that would subvert repeatedly expressed Congressional intent by permitting the distribution of prescription drugs without printed prescribing information on or within the packages from which such drugs are to be dispensed [(see our previous post here)]. The FDA intends to replace such printed labeling with an electronic labeling system for the majority of prescription drugs. On several occasions Congress has directly declined to provide the FDA the necessary statutory authority to implement this change. As recently as 2012, Congress commissioned a GAO report (GAO-13-592) discussing this issue. The GAO report concluded that such a change could adversely impact public health. Thus, the Committee is very concerned that the FDA is moving to promulgate a regulation that would generally eliminate printed prescribing information inserts for prescription drugs. Therefore, the Committee has included a provision prohibiting the FDA from utilizing any funds to propose or otherwise promulgate any rule that requires or permits any prescription drug or biologic products to be distributed without printed prescribing information on or within the packaging from which such products are to be dispensed, unless such actions are expressly provided by an amendment to the FDCA.
Scientific Integrity. – Pursuant to the President’s 2009 memorandum and as directed by the Office of Science and Technology Policy, the FDA adopted a scientific integrity policy in 2012. It appears to conform to the President's directive by maintaining a firm commitment to science-based, data-driven decision making, facilitating the free flow of scientific and technical information, and requiring a fair and transparent approach to resolving scientific disputes. The Committee directs the Commissioner to ensure all FDA centers agencies are complying with the policy and using it to guide their policy and regulatory decisions.
Scientific Study Data. – Sound science, peer review and transparency are essential to effective protection of public health. The Committee is concerned that data from scientific studies utilized in forming public policy may not be available for public review, even under Freedom of Information Act requests. The Committee believes that if public policy is based on a scientific study, that study should be available for public review. The Committee urges the FDA to immediately provide, on its website, the data and studies it uses to support public policy used by the FDA or other Federal agencies based on FDA studies.
Sodium Intake Levels. –The Committee is concerned about the FDA’s continued focus on voluntary sodium reductions and recommendations to remove the GRAS status of sodium given the growing body of evidence that suggests low sodium consumption can lead to health problems in healthy individuals [(see our previous post here)]. The Committee requires the FDA, in coordination with CDC, to convene a panel at the IOM to determine the blood pressure effect and Cardiovascular Disease (CVD) implications for healthy people consuming sodium at 3000 mg or less per day. Federal funds should not be expended on sodium reduction activities below 3000 mg per day until the science is formally considered surrounding healthy and safe sodium intake, especially for healthy individuals, and the impact of lower sodium on blood pressure (and an extrapolation to health), including direct research suggesting a negative impact of lower sodium on health.
Spent Grains. – The Committee recognizes that the FDA took into consideration public comments and revised some of its proposed regulations on spent grains used for animal food. Processors already complying with FDA human food safety requirements would not need to implement additional preventive controls when supplying a by-product like wet spent grains for animal food. However, further processing a by-product for use as animal food such as drying spent grains, would require additional compliance under the proposed rule. The FDA has said potential hazards associated with spent grains are minimal, and steps to prevent contamination are likely already in place. The Committee includes bill language to ensure dry and wet spent grains used for animal food are regulated equally.
Sunscreen Ingredient Applications. – The Committee is concerned that another year has passed without the FDA completing its review of the pending Time and Extent Applications (TEAs) and the OTC Monograph rulemakings on sunscreens. Immediate action on sunscreen applications should be a priority since the need for sunscreens is evident by the nearly five million people that are treated annually for all skin cancers and the fact that melanoma is the fifth leading cause of cancer in the U.S. this year. The bill provides the requested funding of $700,000 for the FDA to complete timely reviews of filed requests and determine the safety and efficacy of sunscreen ingredients.
Sunscreen Ingredients and Report. – Thirteen years have passed without FDA final decisions on sunscreen ingredients that have been used around the world for many years. FDA's inaction is particularly concerning because bipartisan reforms were enacted in the Sunscreen Innovation Act (SIA) addressing all of the issues identified as impediments by the FDA [(see our previous post here)]. The Surgeon General called on the Federal government to work with stakeholders to support skin cancer prevention and yet the FDA has still not approved a new sunscreen product since the 1990s.
The FDA shall produce a report to the Committee by September 1, 2015, that contains a detailed analysis of how the FDA is balancing the Surgeon General's Call to Action, the known public health benefits that regular sunscreen use provides to prevent skin cancer and melanoma, and the long history of safe and effective use of sunscreens currently backlogged at the FDA in comparable countries versus the hypothetical risk sunscreens posed to human health in FDA’s GRAS standard. Furthermore, the FDA shall issue draft guidance for industry outlining data required for sunscreen active ingredients to meet the FDA’s safety and efficacy standards and meet SIA's statutory deadlines for publication. The bill provides $700,000 for FDA's sunscreen activities.
Surrogate Endpoints. – The Committee urges the FDA to issue guidance on the use of surrogate and intermediate endpoints for accelerated approval of regenerative medicine products under section 506(c) of the FDCA (21 U.S.C. 356(c)). In the process of issuing guidance, the FDA shall consult with appropriate stakeholders in the development of this guidance.
Tobacco Product Regulation. – The Committee includes bill language making a technical change to the FDA's regulation of newly deemed tobacco products and products with nicotine derived from tobacco under the Tobacco Control Act (TCA). Current law allows the agency to regulate these newly deemed products, and this language maintains the FDA's authority to ensure their safety through the regulatory process. Notably, the TCA provides the FDA with the authority to require that manufacturers submit detailed product formulas to the FDA for each of their products; authority to review any modifications to these newly regulated products going forward; and authority to issue product standards and other enforcement tools, including misbranding, adulteration and post market surveillance. The Committee fully supports these efforts to reduce potentially harmful effects associated with tobacco products. The Committee also supports FDA efforts to subject certain tobacco products to additional provisions, including minimum age of purchase restrictions, health warnings for product packages and ads, and a prohibition of certain vending machine sales.
Rather than amending the FDA's regulatory authority, this language relates only to a specific date–the predicate date of February 15, 2007. The current predicate date was established arbitrarily with the passage of TCA: Congress determined that manufacturers would not have to submit a pre-market approval application to the FDA for tobacco products that already existed on the market at that time. Those products that came onto the marketplace during the transition period after February 15, 2007 but before June 22, 2009 and introduced 21 months after the law was enacted were permitted to stay on the market as long as the manufacturer submitted a substantial equivalence submission to the FDA before the end of this transition period. Products entering the marketplace after this time period are required to submit a premarket tobacco product application. Using the 2007 date means that newly-regulated categories of tobacco products–some of which have the potential to play an important role in harm reduction, and some of which hardly existed in commerce before that date–would face a more onerous approval process than cigarettes.
On April 25, 2014, the FDA released a proposed deeming regulation, which would grant authority for the agency to regulate cigars, vapor products and other products with nicotine derived from tobacco. The Committee hopes that the FDA finalizes that rule as soon as possible and urges the FDA to develop tobacco product safety standards aimed at reducing or eliminating the most harmful constituents for the safety of our public health, with a special focus on protecting young populations. Manufacturers should have to meet these product standards in order to ensure the safe sale of tobacco products in the marketplace. In particular, the Committee urges the FDA to further the extension of the TCA's national minimum purchase age of 18 years to all tobacco products, regardless of when all other aspects of the deeming rule are made final. Further, the Committee urges the FDA to make child-resistant packaging and warning labels mandatory for liquids used with electronic-cigarette vaporizers.
The Committee believes the FDA has discretion to modify the predicate date for these newly deemed products, but the FDA states that it would maintain February 15, 2007 as the predicate date. The Committee is concerned that this approach will dramatically add to the FDA’s substantial backlog of currently pending applications and create a regulatory logjam for the agency--diverting its attention from its core mission to promote public health, ensure the safe use of these products and prevent underage use and abuse. The Committee has therefore established a new policy that treats newly deemed products in the same way as the TCA treated newly regulated products when the law was enacted. Specifically, the language in this bill would make the predicate date for newly deemed tobacco products the effective date of the final deeming rule and mimic the 21-month transition period provided for cigarettes, smokeless tobacco and roll-your-own tobacco.
For those products that enter the marketplace after the new predicate date, it is the Committee's recommendation that the FDA provide education to manufacturers on how to complete Premarket Tobacco Applications and Substantial Equivalence Reports for newly deemed products. This education could take the form of guidance, webinars, and/or individual meetings with companies. Such outreach and educational efforts are especially important for small companies manufacturing products that have not been previously regulated by the FDA. Lastly, the Committee would support the FDA if the agency distinguished between premium cigars and other tobacco products in regulation. Premium cigars have consistently been shown to be less harmful and addictive, and are distinct from other tobacco products in regards to the perception among youth.
User Fee Collections/Obligations. – The Committee continues to be concerned about the financial management of the FDA’s user fee programs. The Committee directs that not later than 30 days after enactment of this Act, and each month thereafter through the months covered by this Act, the Commissioner to submit to the Committees on Appropriations of the House and Senate a report on user fees collected for each user fee program included in the Act. The report shall also include monthly obligations incurred against such fee collections. The first report shall include a distinct categorization of the user fee balances that are being carried forward into fiscal year 2017 for each user fee account as well as a detailed explanation of what accounts for the balance and what the balance will be used for.
Senate Fiscal Year 2016 FDA Appropriations Bill (S. 1800) & Report (S. Rept. 114-82)
The following provisions are included as “General Provisions” in Title VII of S. 1800:
- SEC. 723. Not later than 30 days after the date of enactment of this Act, the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, and the Chairman of the Farm Credit Administration shall submit to the Committees on Appropriations of the House of Representatives and the Senate a detailed spending plan by program, project, and activity for all the funds made available under this Act including appropriated user fees, as defined in the report accompanying this Act.
- SEC. 729. None of the funds made available by this Act may be used to enforce the final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” published by the Food and Drug Administration in the Federal Register on December 1, 2014 (79 Fed. Reg. 71156 et seq.) before December 1, 2016.
- SEC. 740. None of the funds made available by this Act may be used to propose, promulgate, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of in paper form) unless and until a Federal law is enacted to allow or require such distribution.
Active Pharmaceutical Ingredients. – The Committee is concerned that the FDA has not yet approved a list of active pharmaceutical ingredients [APIs] for use by compounding pharmacists pursuant to the Federal Food, Drug, and Cosmetic Act [FDCA]. Within 90 days of the enactment of this act, the FDA is directed to provide a timeline for when the remaining substances will be considered, and in the meantime re-consider its policy with regard to enforcement of the bulk drug substances provisions under section 503A.
Alcohol Based Hand Sanitizers. – The Committee strongly supports the systematic review of healthcare antiseptic active ingredients used in alcohol based hand sanitizers [ABHS] products marketed under the over-the-counter [OTC] monograph to ensure the safety of healthcare workers and consumers, but is concerned about the potential impacts to public health that could occur if ABHS products containing healthcare antiseptic active ingredients are reclassified in a final monograph without full review of available, appropriate science based data and risk models. The FDA is requested not to issue a final monograph regarding OTC healthcare antiseptic active ingredients that are used in ABHS products, until full and fair consideration is given to existing evidence that has been provided to FDA that supports general recognition of safety and effectiveness of OTC ABHS products, and to potential costs associated with the final monograph.
Biosimilars. – The Committee is concerned that FDA has failed to provide the public adequate opportunity to review and comment on regulatory standards for the approval and oversight of biosimilar drugs. Therefore, FDA is directed to provide the Committee with an estimated timeline by which the agency will: finalize all pending draft biosimilars guidance documents, publish draft biosimilar guidance documents included in its 2015 regulatory agenda, and finalize those draft guidance documents. The Committee expects to receive this report no later than 2 weeks after the Committee reports this legislation.
Centers of Excellence in Regulatory Science and Innovation. – The Committee is encouraged by the ongoing research and collaboration underway at the Centers of Excellence in Regulatory Science and Innovation program and commends the FDA for launching this program in 2011 and expanding it in 2014. As such, the Committee directs the Office of the Commissioner to use at least $2,000,000 within existing funds to provide additional funding opportunities for the existing CERSI Centers to allow for the capitalization of ongoing studies and research.
Comparative Oncology. – The Committee recognizes the value in using data from cancers in companion animals to provide answers to important translational questions about cancer biology, diagnosis, and treatment. This research offers an important opportunity to study cancers in thousands of subjects to benefit both human patients and pets. The Committee requests FDA address the use of companion animals in diagnosis and treatment research and encourage the FDA to open grant opportunities in animal models to increase the study of the 1 million companion animals that naturally develop cancer each year.
Cord Blood Regulation. – The Committee directs the FDA to undergo a review and seriously consider the potential need for revision of the current regulatory requirements for cord blood licensure, particularly those related to manufacturing and storage, to ensure the correct applicability to this industry since the current regulatory requirements being applied are the same ones that apply to pharmaceutical products. In addition, the Committee directs the FDA to create an advisory task force, comprised at a minimum of public and private cord blood bankers, transplanters and patients, to provide recommendations to the agency about the current licensing requirements and changes that may be necessary.
Cosmetics. – The Committee provides not less than $11,700,000 for cosmetics activities, including not less than $7,200,000 for the Office of Colors and Cosmetics [OCAC]. Funding for OCAC is for the direct support of the operation, staffing, compliance, research and international activities performed by this office. The Committee notes that FDA’s budget submission stated that FDA would meet a March 2015 deadline, set by this Committee, to respond to a citizen petition regarding trace amounts of lead in cosmetics. This has not occurred, and this unacceptable delay is indicative of longstanding issues with FDA's review of cosmetics. Since 1976, cosmetic ingredients have been reviewed by a private Cosmetic Ingredient Review program, established by the cosmetic industry, with nonvoting FDA participation. The Committee directs FDA to work with the industry to study the transfer of this program to a more formal public-private partnership, similar to the United States Pharmacopeia, if appropriate and beneficial for consumers, and to report back to the Committee on this effort.
Deeming Regulations. – The Committee notes that the Family Smoking and Prevention and Tobacco Control Act, which became law in 2009, gave FDA immediate authority over certain tobacco products, and gave authority to the Secretary of Health and Human Services to deem other products subject to FDA regulation. On April 25, 2014, nearly 5 years after it had been granted the authority to do so, FDA issued those proposed deeming regulations, but has not yet finalized them. FDA is therefore directed to issue a final regulation addressing the deeming of other tobacco products under FDA's jurisdiction within 30 days and to act expediently to implement that regulation once finalized.
Drug Shortages. – The Committee is very concerned about continuing drug shortages, and the serious effects they can have on patients, including children. The Committee directs the Food and Drug Administration to report to the Committee on the work of FDA's intra-agency Drug Shortages Task Force. This report should include which offices and centers are represented on the task force, and how it works with other government agencies and outside stakeholders to address drug shortages. The report should also specify what activities the Task Force has undertaken to prevent drug shortages affecting pediatric patients, including working with outside experts on this issue.
Duchenne Muscular Dystrophy. – The Committee is aware that a patient-focused draft guidance for drug development on Duchenne Muscular Dystrophy was submitted to FDA in June 2014. The Committee supports this initiative and requests that FDA provide a detailed description of its plans to move forward with the development of a related guidance.
Farm Regulations. – The Committee remains concerned about how the FDA will determine whether and to what degree a farm or food business is subject to regulation. It is important that FDA is careful to apply new rules appropriately for the size of the operation in accordance with congressional intent.
Foreign High Risk Inspections. – As the importation of drugs, food, and medical devices from China continue to increase, the Committee is concerned about the FDA’s ability to keep pace with the exporter universe and volume of exports. For fiscal year 2015, an additional $2,000,000 was provided for foreign drug safety to address the growing number of human drugs produced overseas and the increasing number of imported drug shipments in order to ensure the continued safety and quality of these products. These funds have been provided to support the agency's overseas inspections, work with industry and other stakeholders in safety in manufacturing, strengthen agency relationships with foreign regulators, and analyze trends and events that might affect the safety of FDA-regulated products exported to the United States.
The Committee is supportive of FDA as it moves toward a more, targeted, risk-based, and efficient inspection model that incorporates commercially available information on high-risk establishments. As with other Federal agencies, such as CMS, better data has helped to make sure a company exists and is in good standing prior to an inspection and to help prioritize FDA's investigations and triage safety inspections. Within the funds provided for the China Safety Initiative the Committee directs the FDA to maintain robust funding for onsite verification support and integration of results in FDA inspection planning.
In Silico Clinical Trials. – In Silico clinical trials use computer models and simulations to develop and assess devices and drugs, including their potential risk to the public, before being tested in live clinical trials. Advanced computer modeling may also prove useful in helping to predict how a drug or device will behave when deployed in the general population or when used in particular circumstances, thereby helping to protect the public from the unintended consequences of side effects and drug interactions. In Silico trials may potentially protect public health, advance personalized treatment, and be executed quickly and for a fraction of the cost of a full scale live trial. The FDA has advocated the use of such systems as an additional innovative research tool. Therefore, the Committee urges FDA to engage with device and drug sponsors to explore greater use, where appropriate, of In Silico trials for advancing new devices and drug therapy applications.
In Vitro Clinical Trials. – In Vitro clinical trials use specimens collected from patients to test how a particular cancer or disease will react to a specific therapy or combination of therapies. This personalized approach to treatment can improve a patient’s quality of life by increasing the likelihood that physicians and researchers will find the proper combination of drugs uniquely suited to treat that individual’s illness. An emerging new scientific methodology, In Vitro trials allow researchers to test therapeutics and treatment strategies on living human tissues without the risks posed by traditional whole patient clinical trials. Personalized treatment through In Vitro trials dismantles the “one size fits all” approach to care and enables medical professionals to diagnose and treat patients in a more efficient and effective way. While the Committee recognizes that In Vitro tests may not always predict clinical responses, it urges the FDA to continue to engage with drug sponsors to explore greater use, where appropriate, of In Vitro clinical trials for drug development programs under Investigational New Drug applications and general therapeutic indications, especially as it relates to complicated cancers and other common disease states.
Mammography Quality Standards Act. – The Committee recommendation includes full funding as requested for implementation of the Mammography Quality Standards Act. This program sets national quality standards for mammography facilities, equipment, personnel and operating procedures, and has improved the quality of mammography and made mammograms a more reliable tool to detect breast cancers.
Mammography Reports. – The Food and Drug Administration is directed to revise its regulations regarding the summary mammography reports in lay language provided to patients to require the inclusion of information on the patient's breast tissue density; an explanation that dense tissue may mask the presence of breast cancer on mammograms; and advice that patients speak with their healthcare provider about whether they would benefit from additional tests, and about any other questions they may have. The FDA should also revise its regulations regarding the medical report provided to healthcare providers to require the inclusion of information on the patient's breast density and the masking effect such tissue may have on detecting breast cancer.
Master Plan. – The Committee has included $3,000,000 for FDA to complete a feasibility study to update and issue a revised Master Plan for the White Oak campus in order to address its expanded workforce and the facilities needed to accommodate them. The Committee directs FDA to report on this effort by January 1, 2016.
Medical Gases. – The Committee is concerned that FDA has not initiated rulemaking to address numerous longstanding regulatory issues for medical gases despite the statutory requirement in FDASIA to issue a final rulemaking addressing all necessary changes for medical gases by July 9, 2016. Designated medical gases are a unique class of drugs that differ significantly from traditional pharmaceuticals and therefore must be addressed in the Federal drug regulations to prevent safety and enforcement issues caused by current regulations. The Committee disagrees with the FDA report to Congress sent on June 30, 2015 that despite decades of issues created by existing regulations “the current regulatory framework is adequate and sufficiently flexible to appropriately regulate medical gases.”
Nanotechnology. – The Committee recognizes the increased capabilities that FDA has developed to study environment, health, and safety of nanomaterials within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The Committee expects FDA to continue to support collaborative research with universities and industry on the toxicology of nanotechnology products and processes in accordance with the National Nanotechnology Initiative Environment, Health, and Safety Research Strategy as updated in October 2011.
National Antimicrobial Resistance Monitoring System. – The Committee recommendation includes $10,800,000 for the National Antimicrobial Resistance Monitoring System, equal to the level provided in fiscal year 2015.
Nutrition Facts Label. – The Committee is concerned that the FDA has not published in the Federal Register the results of FDA’s “Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars” (78 FR 32394, May 30, 2013). The purpose of the study, as described by the Agency, is “to examine how consumers would comprehend and use this new information”. Given that sound science, peer review and transparency are essential to effective protection of public health, the Committee encourages the FDA to release this study for public review and comment prior to finalizing changes to the Nutrition Facts label.
Opioid Overdose Prevention. – The Committee notes that on June 15, 2015, the CDC issued a report on “Opioid Overdose Prevention Programs Providing Naloxone to Laypersons”, in which the CDC noted the benefits of expanding access to the life-saving drug naloxone, which reverses the effects of an opioid overdose. The Committee urges FDA to promote the development and widespread usage of naloxone products. The agency’s efforts should include working closely with product sponsors interested in marketing naloxone for use without a prescription to expedite review and decisionmaking.
Oversight Activities. – The Committee notes that over the past 5 years FDA’s responsibilities and resources have grown significantly. The Committee is concerned that oversight of FDA has not kept pace with the growth in the agency's regulatory authority or funding. Therefore, the Committee recommendation includes $1,500,000 for the HHS Office of Inspector General specifically for oversight of FDA activities. The funding provided under this appropriation is in addition to FDA oversight activities supported within the Inspector General’s regular appropriation. The Committee instructs the Inspector General to submit a plan, within 60 days of the enactment of this act, on the additional oversight activities planned with this funding.
Pediatric Device Consortia Grants. – The Committee is pleased that the nine FDA-funded Pediatric Device Consortia have assisted in the development of more than 450 proposed pediatric medical devices since its inception in 2009, as well as promoting job-growth in the healthcare sector, and as such, continues to support this critical effort. The program funds consortia to assist innovators in developing medical and surgical devices designed for the unique needs of children that often go unmet by devices currently available on the market. The Committee directs FDA to fund this program at the highest possible level within available resources, and at no less than the level funded in the previous year.
Repackaging for Long Term Care Pharmacies. – In February the Food and Drug Administration released a draft guidance entitled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” The Committee is concerned that in issuing the draft guidance the agency failed to consider the unique nature of long term care pharmacies and the populations they serve. Before issuing a final guidance the Committee urges the agency to consider its implications on patient access to safe and effective medications from long term care pharmacies.
Seafood Advisory. – The Committee remains concerned that despite numerous commitments over many years, FDA has not published final advice on seafood consumption for pregnant women, mothers, and children. The Committee is pleased that FDA released draft advice in June 2014, however, pregnant women and healthcare providers still await clear, actionable and science-based final seafood advice. Based on the recommendation of the Dietary Guidelines Advisory Committee, the final FDA seafood advice shall re-evaluate the draft limit on albacore tuna to ensure it is consistent with the FDA net effects report and the Joint United Nations Food and Agriculture Organization/World Health Organization Expert Consultation on the Risks and Benefits of Fish Consumption, 2010. The Committee directs FDA to publish final advice to pregnant women on seafood consumption in conjunction with all applicable parties. Finally, FDA shall provide a progress report to the Committee 30 days after the enactment of this act and every 30 days thereafter until the final seafood advice is published.
Seafood Economic Integrity. – The Committee recognizes the importance of seafood to a healthy diet, but is concerned that the FDA does not focus sufficient attention on economic integrity issues, particularly with respect to mislabeling of species, weights, and treatment. The Committee encourages the FDA to work with States and the Department of Commerce to more aggressively combat fraud in parts of the seafood industry.
Seafood List. – The Committee directs the Commissioner to expedite consideration of whether it is appropriate to change the acceptable market name of Gadus chalcogrammus (formerly classified as Theragra chalcogramma) from “Alaska Pollock” to “Pollock” in the Seafood List. It is critical that seafood nomenclature (acceptable market names) is science-based, truthful, and not misleading to the consumer.
Sodium. – The Committee is concerned about FDA's continued focus on voluntary sodium reductions and the Institute of Medicine’s [IOM] 2010 recommendation to modify the Generally Recognized as Safe [GRAS] status of sodium, particularly given the ongoing scientific discussion regarding appropriate sodium intake to maintain positive health. The IOM published a more recent study in 2013, which concluded additional research may provide further information with respect to the health effects of sodium intake on general and sub populations. The Committee recommends that a panel be convened, at the IOM or another leading Federal institution, which includes a representative array of research perspectives, including those who have raised concerns on the safety of low-sodium diets. The Committee does not believe any sodium reduction activities should be finalized until the disagreement between the impact of lower sodium on blood pressure (and an extrapolation to health) and direct research suggesting a negative impact of very low-sodium intakes is resolved.
Sunscreen. – The Committee is aware that in July 2014, the U.S. Surgeon General issued A Call to Action to Prevent Skin Cancer, concluding nearly 5 million people are treated annually for all skin cancers combined, with an estimated cost of $8,100,000,000 per year. As a result, the Surgeon General called on the Federal Government to work with stakeholders to support skin cancer prevention. The Committee is pleased with the bipartisan reforms enacted in the Sunscreen Innovation Act[SIA] in 2014 to improve the process by which the FDA reviews sunscreen ingredients; however, the Committee is concerned that while skin cancer rates in the United States continue to climb, no new sunscreen ingredients have been generally recognized as safe and effective [GRASE] by the FDA since passage of the SIA. The Committee directs the FDA to provide a report that contains a detailed analysis of how FDA is balancing the Surgeon General's Call to Action, the known public health benefits that regular sunscreen use provides to prevent skin cancer and melanoma, and the long history of safe and effective use of sunscreens in comparable countries versus the hypothetical risk sunscreens posed to human health in FDA’s generally recognized as safe and effective [GRASE] standard. Immediate action on sunscreen applications should be a priority.
In addition, the Committee directs the FDA to work with stakeholders to ensure consumers in the United States have access to all sunscreen products that have been shown to be safe and effective; and therefore, requests that FDA, in finalizing the sunscreen monograph consistent with the SIA, include provisions related to the maximum Sun Protection Factor [SPF] and to address spray dosage forms for sunscreens.
Vibrio. – The Committee is aware of the public health challenge related to the naturally occurring bacteria called Vibrio parahaemolyticus (V.p.) that can accumulate in shellfish and believes that more scientific research is necessary to developing proper controls that will reduce the risk to consumers and sustain a healthy domestic shellfish industry. The Committee encourages the Food and Drug Administration [FDA] to increase funding for research into Vibrio illnesses associated with the consumption of raw molluscan shellfish, improve risk assessment models, and develop improved rapid detection methods for virulent Vibrio strains.
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