Posted: 15 Dec 2016 05:38 PM PST
By Michelle L. Butler & James E. Valentine –
As we previously reported, the President signed into the law the 21st Century Cures Act (Act) on December 13, 2016 (find the full text here). This post is part two of a two-part post that summarizes the relevant provisions related to development of drugs and biologics. Part one of this summary (covering Subtitles A-D of Title III of the Act) can be found here.
In addition, Hyman, Phelps & McNamara, P.C.’s summary of Subtitle F of Title III of the Act pertaining to medical device development provisions can be found here. We expect to publish additional posts, including a post summarizing the combination product provision and a post summarizing relevant health care provisions.
Here is a summary of Subtitles E, G-I of Title III of the Act pertaining to drug development.
Subtitle E—Antimicrobial Innovation And Stewardship
Sec. 3041. Antimicrobial resistance monitoring.
Section 3041 amends the Public Health Service Act (PHS Act) to require HHS to encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and implementation of antimicrobial stewardship program by the DoD, VA, and the Indian Health Service. The section also directs HHS to provide technical assistance to the DoD and VA as appropriate and upon request.
The section requires HHS to publish a report on antimicrobial resistance in humans and use of antimicrobial drugs, including qualified infectious disease products under section 506(h) of the Federal Food, Drug, and Cosmetic Act (FDC Act). The report is required within one year of the date of enactment of the Act. In addition, HHS is directed to disseminate, as appropriate, guidance and educational materials related to development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities.
The section requires HHS to work with State and local public health departments on programs related to antimicrobial resistance.
To fulfill the purposes of this section, HHS is directed to provide a mechanism for facilities to report data related to their antimicrobial stewardship activities.
Sec. 3042. Limited population pathway.
Section 3042 amends the FDC Act to allow FDA to approve an antibacterial or antifungal drug, along or in combination with other drugs, as a limited population drug if:
A drug approved under this section is subject to the following requirements:
The section also requires FDA to issue draft guidance describing criteria, processes, and other considerations for demonstrating safety and effectiveness of limited population antibacterial and antifungal drugs. FDA has 18 months to issue the draft guidance document, and another 18 months after the public comment period on the draft guidance ends, to issue a final guidance. However, FDA may still approve antibacterial and antifungal drugs under this section prior to issuing such guidance.
The section requires FDA to provide prompt advice to the sponsor of a drug seeking approval under this section.
In addition, FDA must report to Congress at least every other year the number of requests for approval and the number of approvals of drugs under this section. No later than December 2021, GAO must also provide Congress a report on the coordination of activities of the Antimicrobial Resistance Task Force and the approval pathway under this section.
Sec. 3043. Prescribing authority.
Section 3043 specifies that nothing in Subtitle E of the Act restricts the prescribing of antimicrobial drugs and other products, including qualified infectious disease products, by health care professionals, or otherwise limits the practice of health care.
Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices.
Section 3044 amends the FDC Act to clarify FDA’s authority to update susceptibility test interpretive criteria for antimicrobial drugs (i.e., to determine how much of a drug to use and which infections a drug is useful in treating) when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs. Unique management of such drugs is necessary to delay or prevent the development of further resistance. The section requires FDA to identify appropriate susceptibility test interpretive criteria for such drugs at the time of approval, if available, or at some later date that they become available. The bases for initial identification of these criteria must be based on available and relevant:
The section also requires, within one year of the establishment of the Interpretive Criteria Website, a holder of an approved NDA or BLA to remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website. This can be accomplished through an annual report. Drugs approved after the establishment of the Interpretive Criteria Website must include reference to the website.
In addition, the section creates special conditions for marketing of antimicrobial susceptibility testing devices if those devices meet the following conditions:
Subtitle G—Improving Scientific Expertise And Outreach At FDA
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.
Section 3071 amends the PHS Act to expand the Silvio O. Conte Senior Biomedical Research Service from a maximum of 500 members to 2000 members, which allows the recruitment of additional qualified scientific and technical experts in biomedical research, clinical research evaluation, and biomedical product assessment across HHS. The section also increases the maximum salary of the members to now not exceed the amount of annual compensation of the President (currently $400,000 per year).
The section also directs GAO to study the effectiveness of these reforms on all agencies or departments within HHS that must be provided to Congress as a report within 4 years of the date of enactment of the Act. The GAO study and report must address:
Section 3072 amends the FDC Act by allowing FDA to appoint scientific, technical, or professional positions that support the development, review, and regulation of medical products within the competitive service. In addition, the section provides that such appointments may have a maximum salary to now not exceed the amount of annual compensation of the President (currently $400,000 per year).
The section requires FDA to provide to Congress, within 18 months of the date of enactment of the Act, a report on workforce planning that examines FDA’s need for qualified individuals for scientific, technical, or professional positions. The report must address:
Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes.
Section 3073 amends the FDC Act to require FDA to establish one or more “Intercenter Institutes” within FDA for a major disease area or area. Such Intercenter Institute is directed to develop and implement processes for coordination of activities, as applicable to the disease area(s), among CDER, CBER, and CDRH, including:
Sec. 3074. Scientific engagement.
Section 3074 establishes that scientific meetings that are attended by HHS professionals for whom attendance is directly related to their professional duties and the mission of HHS (a) are not considered conferences for the purposes of complying with Federal reporting requirements contained in annual appropriations Acts and (b) are not considered conferences for purposes of a restriction contained in an annual appropriations Act or any other regulation restricting travel to such a meeting.
The section requires each operating division of HHS to post an annual report on scientific meeting attendance and related travel spending for each fiscal year no later than 90 days after the end of the fiscal year.
Sec. 3075. Drug surveillance.
Section 3075 amends the FDC Act to make targeted revisions to FDA’s drug surveillance program. FDA will have more flexibility related to existing requirements that it screen the Adverse Event Reporting System database and evaluate its REMS program. The section also directs FDA to make publicly available best practices for drug safety surveillance using the Adverse Event Reporting System and criteria for public posting of adverse event signals.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
Section 3076 amends the FDC act to amend the governance of the Board of Directors in the following ways:
Subtitle H—Medical Countermeasures Innovation
Sec. 3081. Medical countermeasure guidelines.
Section 3081 amends the PHS Act to require HHS to ensure timely and accurate recommended utilization guidelines for qualified countermeasures, qualified pandemic and epidemic products, and security countermeasures, including for such products in the Strategic National Stockpile.
The section also requires HHS, no later than March 1 of each year in which HHS determines that the amount of funds available for procurement of security countermeasures (i.e., in the BioShield Special Reserve Fund) is less than $1.5 billion, to submit to Congress a report detailing the amount of such funds available for procurement and the impact of such amount on:
Section 3082 amends the PHS Act to direct Biomedical Advanced Research and Development Authority (BARDA) to carry out programs funded by the special reserve fund (e.g., for procurement of security countermeasures), specifically including the execution of procurement contracts, grants, and cooperative agreements.
Sec. 3083. Countermeasure budget plan.
Section 3083 amends the PHS Act to direct HHS to develop a five-year budget plan based on medical countermeasures priorities, including addressing novel or emerging infectious diseases and the efforts to development medical countermeasures for such threats. Finally, the section specifies that the plan must be provided to Congress no later than March 15 of each year and must be made publicly available.
Sec. 3084. Medical countermeasures innovation.
Section 3084 amends the PHS Act to direct BARDA to enter an agreement with an independent, nonprofit entity (a Medical Countermeasures Innovation Partner) to:
Sec. 3085. Streamlining Project BioShield procurement.
Section 3085 amends the PHS Act to remove certain steps from the BioShield Special Reserve Fund, which is intended to reflect current execution of the fund. The section also requires HHS to notify Congress of each decision to make special reserve funds for procurement of a security countermeasure. Finally, the section makes available payments from the special reserve fund to a vendor for procurement of a security countermeasure.
Sec. 3086. Encouraging treatments for agents that present a national security threat.
Section 3086 amends the FDC Act to establish a priority review voucher program for a “material treatment medical countermeasure application,” which is
The section also provides specific requirements regarding notice of use of the priority review voucher: at least 90 days notice to FDA prior to submission of the application, which serves as a legally binding commitment to pay the user fee. A sponsor may transfer the voucher after such notice is given, provided that the application has not yet been submitted.
Furthermore, the section requires FDA to publish notice in the Federal Register and on FDA.gov within 30 days of (a) issuing a voucher under this section and (b) approving a drug that used a voucher issued under this section. The section limits the eligibility of applications from receiving more than one priority review voucher under the various voucher programs. The awarding of vouchers under this section sunsets after October 1, 2023.
Sec. 3087. Paperwork Reduction Act waiver during a public health emergency.
Section 3087 amends the PHS Act by allowing HHS to make a determination that waives voluntary collection of information from the Paperwork Reduction Act requirements during the period of a public health emergency or the period of time necessary to determine if a disease or disorder will become a public health emergency, or for a reasonable period of time during the immediate postresponse review regarding the public health emergency. If HHS determines that a waiver is necessary, it must promptly post on the HHS website a brief justification for the waiver, the anticipated timeframe, and the HHS agencies and offices that the waiver applies to; this must be updated, as applicable.
Sec. 3088. Clarifying Food and Drug Administration emergency use authorization.
Section 3088 amends the FDC Act to explicitly allow for emergency use authorizations for animal drugs.
Subtitle I—Vaccine Access, Certainty, And Innovation
Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices.
Section 3091 directs the Advisory Committee on Immunization Practices, as appropriate, upon licensure of any vaccine or any new indication for a vaccine, to consider the use of the vaccine at its next regularly scheduled meeting. If the Advisory Committee does not make a recommendation regarding use of the vaccine, it must provide an update on the status of its review.
The section also directs the Advisory Committee to make recommendations with respect to use of certain vaccines in a timely manner, including those that are designated as Breakthrough Therapies or could be used in a public health emergency.
Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations.
Section 3092 requires the Centers for Disease Control and Prevention (CDC) to conduct a review, with input from vaccine stakeholders, of the processes used by the Advisory Committee on Immunization Practices in formulating and issuing recommendations pertaining to vaccines, including with respect to consistency. Such review must include an assessment of:
Sec. 3093. Encouraging vaccine innovation.
Section 3093 directs CDC to ensure that its staff within the Office of Infectious Diseases coordinate with respect to public health needs, epidemiology, and program planning and implementation considerations related to immunizations, including with regard to meeting with stakeholders.
Specifically, the section requires HHS, in collaboration with NIH, CDC, FDA, and BARDA, and in consultation with the DoD, VA, and stakeholders, to submit to Congress and post on the HHS website a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious diseases. The report must include:
If you have questions or need more information, contact:
viernes, 16 de diciembre de 2016
FDA Law Blog - Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
FDA Law Blog: Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)