Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.

Due to this delay, industry remains in a state of uncertainty regarding the FDA’s position regarding off-label uses. This uncertainty has persisted for several years, following several key court cases related to off-label, the issuance of a draft rule in 2015, and FDA public hearings related to off-label held by the FDA last year. Interested parties are urged to provide comments to the FDA, due within 60 days, regarding intended use. The FDA is requesting comments regarding the following topics:

  1. How should FDA consider situations such as those described in the announcement where companies and individuals distribute medical products and/or seek to import medical products without explicit promotional claims as FDA evaluates whether to adopt any of petitioners’ suggested approaches to determining intended use?
  2. What are the potential public health consequences, positive and negative, that should be considered in evaluating whether to adopt any of petitioners’ suggested approaches to determining intended use? What other policy considerations are relevant when assessing approaches to intended use?
  3. To the extent that your comment cites to First Amendment considerations as the legal rationale underlying your recommendations, how (if at all) do those considerations apply to the use of non-speech evidence in determining intended use, such as the circumstances surrounding the distribution of a product or the context in which it is sold?
  4. In light of the petitioners’ concerns about the language in the Final Rule, do stakeholders believe there is a distinction between considering “any relevant source of evidence” and “the totality of evidence”? Do stakeholders have suggestions about what wording provides the most clarity to regulated entities?
  5. Any other pertinent comments or information stakeholders would like to share regarding the Final Rule, including whether there are other approaches to “intended use” that FDA should consider.

The FDA also stated in the announcement that it is “currently engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products” and urged interested parties to provide relevant comments to that docket, which is open until April 19, 2017.   

Posted by Sarah K. diFrancesca