martes, 24 de enero de 2017

FDA Law Blog: Winter Freeze Descends on Nation’s Capital

FDA Law Blog: Winter Freeze Descends on Nation’s Capital

Posted: 24 Jan 2017 01:22 AM PST
By Etan J. Yeshua –

On January 20, 2017, the Trump administration took a first step toward delaying, reconsidering, and potentially undoing numerous regulations and policies issued by the Obama administration. In order to ensure that “the President’s appointees or designees have the opportunity to review any new or pending regulations,” White House Chief of Staff Reince Priebus issued to the heads of executive departments and agencies a memorandum titled “Regulatory Freeze Pending Review.”

The memo first requests that no regulation be sent to the Office of the Federal Register for publication until a Presidential appointee or designee has reviewed and approved it. Second, the memo states that regulations that were sent to the Office of the Federal Register but that have not yet been published in the Federal Register are to be immediately withdrawn, and then reviewed by a Presidential appointee or designee. Lastly, regulations that have been published in the Federal Register but that have not yet taken effect are to have their effective date postponed for 60 days (from January 20, 2017), after which the agency or department is to “consider potentially proposing further notice-and-comment rulemaking” and, if further action is deemed appropriate, “agencies should notify the OMB Director and take further appropriate action in consultation with the OMB Director.”    

The freeze applies not only to final regulations but also to notices of proposed rulemaking, guidance documents, and other “substantive action by an agency . . . that is or is expected to lead to the promulgation of a final rule,” as well as to “any agency statement of general applicability and future effect ‘that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.’” The memo provides exceptions for “emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters,” and for regulations that are subject to statutory or judicial deadlines.

The implications for industry have the potential to be significant and the freeze may provide an opportunity to further engage with agencies and departments and to influence pending rules and policies. For example:

  • On January 13, 2017, FDA reopened the comment period – until February 13, 2017 – requesting data to help the Agency determine whether certain food ingredients should be added to the definition of “dietary fiber”;FDA action could be delayed once the comment period closes. 
  • On January 9, 2017, FDA published in the Federal Register a final rule to clarify when products made or derived from tobacco are regulated as drugs, devices, or combination products; the rule was scheduled to take effect on February 8, 2017, but that effective date could now be delayed while the new administration reconsiders the regulation.
  • On January 5, 2017 HHS published in the Federal Register a final rule implementing the 340B Drug Pricing Program Ceiling Price policy and Civil Monetary Penalty (“CMP”) standards, including the knowledge requirement related to overcharging 340B Covered Entities (which we blogged about here).The rule was scheduled to take effect on March 6, 2017. That effective date could now be delayed, at least as it pertains to the implementation of the Ceiling Price policy, while the new administration reconsiders the regulation. The CMP regulation was required to be promulgated within 180 days of the enactment of the Affordable Care Act, and although HHS missed that statutory deadline, the CMP regulation may still be covered by the memo’s exception for regulations that are subject to statutory deadlines.
It appears that the new administration has already begun withdrawing documents that had been sent to the Office of the Federal Register and were in the pre-publication stage.  The following “Editorial Note” appears on affected docket webpages: “The FDA requested the withdrawal of this document after it was on public inspection.  It will remain on public inspection until the close of business on January 24.  A copy of the withdrawal request is available at the Office of the Federal Register.”
Posted: 23 Jan 2017 10:05 AM PST
By Anne K. Walsh –

It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address “unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally,” which it did not.  Instead, two years after their self-imposed deadline, FDA convened a public meeting to solicit views on these same issues (discussed here).  The comment period for that hearing officially closed on January 9, 2017, and although FDA has published two draft guidance documents touching on communications consistent with the approved labeling or related to healthcare economic information (to be discussed in a separate blog post), FDA punted on the critical issue of off-label promotion.

On January 19, 2017, ten days after the comment period closed, FDA reopened the comment period for 90 days (until April 19, 2017).  According to FDA, commenters at the November 2016 hearing complained that “FDA had not sufficiently discussed the First Amendment in the notification of public hearing.”  82 Fed. Reg. 6367, 6368 (Jan. 19, 2017).  Note that the original Federal Register notice stated FDA solicited comments on “ongoing developments in science and technology, medicine, health care delivery, and constitutional law,” 81 Fed. Reg. 60299, 60300 (Sept. 1, 2016) (emphasis added), and anyone even superficially following these issues understands the First Amendment implications involved.  FDA announced that it had prepared a Memorandum to specifically address First Amendment considerations and FDA’s initial reaction to proposed approaches to addressing them, and asked for public comment on the Memo.

The 60-page document is substantively light, as there is much background and rehashing of FDA’s legal authority contained in earlier public statements and briefs. FDA spends considerable time articulating the public health interests affected by communications about unapproved uses. FDA touts its efforts to date as claiming “to strike a careful balance, supporting medical decision-making for patients in the absence of better options, but doing so without undermining the measures designed to incentivize the development and approval/clearance of medical products that would reduce the need to rely on unapproved use, in light of its risks.” FDA Memo, at 20. 

In the Memo, FDA describes its view of case law addressing the First Amendment and FDA regulation of off-label communications. Consistent with earlier statements, FDA attempts to limit the Second Circuit ruling in United States v. Caronia by claiming it does not hold that speech cannot be used as evidence of intended use if the misbranding charge is based solely on truthful, non-misleading speech regarding the unapproved use of an approved product.  FDA relies on a footnote in a qui tam matter in which the Second Circuit opines about the potential use of promotional speech in an FDA enforcement action, without reference to the truthful or non-misleading nature of the speech.  FDA Memo at 22.  FDA also undermines the Caronia decision for not taking into account a study published last year that purportedly shows an association between unapproved uses and adverse drug events. Id. at 23-24.  It is ironic that FDA relies on a published study to support its position, yet puts significant restrictions on the distribution of similarly credentialed literature by industry.

The meat of the memo is FDA’s identification of alternative approaches to address off-label promotion, and the outright rejection of all of the approaches. They include:

  1. Prohibiting altogether the use and/or prescribing of an approved/cleared medical product for an unapproved new use – thankfully FDA rejects this position as potentially injurious to the health care providers and patients that can benefit from determining the best treatment options for each patient.
  2. Barring approval of generics and other affected products until all periods of exclusivity on the reference product have expired – FDA rejects this alternative because it is contrary to the goal of Congress to ensure consumers benefit from lower-priced versions of products.
  3. Creating ceilings or caps on the number of prescriptions for an unapproved use – FDA rejects this approach because, among other things, it typically is unknown for what specific use a health care provider prescribes a product.
  4. Limiting Medicare and Medicaid reimbursement to approved uses – FDA rejects this idea because it limits health care provider discretion, and like option #3, would be impossible to administer.
  5. Prohibiting specific unapproved uses that are exceptionally concerning or developing tiers based on level of safety concerns with greater regulatory controls for the relatively higher risk products – FDA rejects this approach because it undermines the incentives to engage in premarket review and conduct the necessary research to demonstrate safety and effectiveness. Note, however, that FDA already employs a mechanism in certain circumstances: the REMS program.
  6. Requiring firms to list all potential indications for a product in the initial premarket application – FDA rejects this idea because it is not possible to know all potential uses of a medical product from an initial study.
  7. Allowing firms to actively promote an unapproved use as long as they disclose that the use in unapproved and include other appropriate warnings – FDA rejects this approach because “studies show there are limitations to disclosures in terms of the recipients’ perception and understanding.” Also, for devices, FDA is concerned that a firm would use the 510(k) pathway for one intended use, and market for different intended uses for which premarket approval is necessary.
  8. Educating health care providers and patients to differentiate false and misleading promotion from truthful and non-misleading information – FDA claims this it is not feasible for the government to conduct a training program on the scale necessary. Yet FDA does have a coordinated campaign targeted on this very issue, the Bad Ad program: “FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.” Indeed, it is designed to “help healthcare providers recognize misleading prescription drug promotion,” and there is an entire course and case studies devoted to this program.
  9. Reminding health care providers of potential malpractice liability – FDA rejects this approach as counter to the interest in allowing health care providers to determine the best treatment options for patients.
  10. Taxing firms more heavily for sales of products for unapproved uses than for approved uses – FDA rejects this approach because it does not align with the government’s interest of allowing some off-label prescribing or use, and would be impractical to administer and enforce.
  11. Permit promotion of unapproved uses listed in medical compendia – FDA rejects reliance on medical compendia because of publication bias and the potential for improper influence in compendia listings.
  12. Limiting evidence that could be considered relevant to intended use to speech that the government can prove is false or misleading – FDA rejects this “legal until proven wrong” approach because it could undermine the current incentives to generate scientific evidence.
In essence, FDA has a myriad of reasons not to loosen or tighten restrictions about communications of unapproved uses. Although FDA may rely on these reasons to justify the paralysis the Agency has experienced for the last several years, business and innovation do not stand still.  We will continue to closely follow the comments submitted to this latest FDA notice, and FDA’s response.

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