Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications

In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including industry, health care professionals, patient advocates, health care organizations, payors and insurers, academic institutions, and public interest groups. FDA is asking for input on the extent to which industry communications about unapproved uses can provide access to information that is “relevant, scientifically sound, [and] responsibly presented.” The Agency is also interested in the pros and cons of these communications with respect to public health, as well as the appropriate limitations on these communications, including distinctions with respect to audience and product type, among others, that may be appropriate. Given that health care professionals can already access scientific information about unapproved uses through other channels, FDA seeks input on whether and in what ways firms’ communications may provide “unique benefits” compared to other sources of information on unapproved uses. The Agency also notes that technological and business changes have affected prescribing decisions, and is soliciting comments on whether and how changes in “value-based” assessments of medical products may incentivize generation of data on the benefits and risks of a medical product. FDA’s notice sets forth numerous questions for consideration, including:

  • What are the benefits and risks of increased communication on unapproved uses for clinical decision making, coverage, and reimbursement?
  • To what extent do changes that give payors more influence on prescribing decisions incentivize firms to generate high-quality data on safety and effectiveness for new uses?
  • What impact does increasing availability of information on unapproved uses of approved/cleared medical products have on firms’ incentives, including financial incentives, to communicate this information?
  • What standards should apply to unapproved use communications to minimize the potential for these communications to be misleading or harmful?
  • What factors should FDA consider in evaluating whether firms’ communications are truthful and non-misleading, including any disclosures that should be made?
  • What specific regulatory changes should FDA consider as it assesses these issues, particularly following its September 25, 2015, notice of proposed rulemaking (80 FR 57756) proposing changes to the intended use regulations? [See our previous blog post here]
The hearing will be held on November 9 and 10, 2016 from 9 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Individuals who wish to attend or present at the hearing must register on or before October 19, 2016 by contacting Kristin Davis at 301-796-0418. A link to a live Webcast and a video recording of the public hearing will be available at Individuals who wish to present at the hearing must register and identify the questions on which they wish to present. Presenters must submit an electronic copy of their presentation to [email protected] by October 26, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017. Please contact your Hogan Lovells attorney with any questions or for more information.

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