FDA’s Seven-Year Itch

Almost seven years to the day of the FDA’s November 2009 two-day Part 15 hearing on social media, a new Part 15 meeting on off-label communications, Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing, will be held.

The 2009 affair was “The Super Bowl of Part 15 hearings.” Attended by hundreds of interested stakeholders, many of whom were skilled communications professionals, the FDA listened as speaker after speaker (including me) offered timely comments on the new frontier of social media. The FDA listened — and then waited until June 2014 to issue draft guidance.

The big difference between that meeting and the November 2016 version is that there are already a slew of lawsuits that have seriously undercut the agency’s authority in regulating off-label speech. Another important difference is that industry already has released its own guidelines. It’s also important to note the meeting will take place immediately after national elections. If the folks at White Oak think this will deter attention, they are mistaken.

Off-label communications is about getting the right medicine to the right patient in the right dose at the right time — even though the right medicine or the right dose may not correspond precisely to the FDA label. But who is the leader and who is the follower? Or perhaps a better question to ask is, why can’t we all be leaders?

Health providers already have the ability to access scientific information about off-label uses for drugs, such as through scientific journals, clinical practice guidelines or by requesting that information from firms. FDA is therefore seeking comment “on the extent to which additional communications from firms about unapproved uses can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information.”

The agency is soliciting comments as to the ways communications from drug makers regarding off-label use information are distinct, and whether they provide unique benefits compared to other sources. The announcement lays out eight lengthy sets of questions. Some specific ones are:

  • What are the benefits for clinical decision making, research, coverage, reimbursement or other purposes if firms communicate to health care professionals, payers, researchers and patients information about off-label uses? Are there risks, and ways to mitigate these risks?
  • To what extent do changes occurring in the health care system that give payers and formulary committees more influence on prescribing decisions provide incentives for firms to generate the necessary high-quality data demonstrate safety and effectiveness for off-label uses?
  • What processes do firms use to determine whether information is scientifically appropriate to communicate to health care professionals about a product?
  • What information should firms communicate to make audiences aware that the medical product is not indicated for a certain use and to distinguish between the approved uses of the medical product and the unapproved use?

The agency is asking a lot of excellent questions, but they’ve had a lot of time to ponder all of them already. The only thing that is clear is that no guidance on the topic will be forthcoming until well after a new president takes office — and that could have profound implications on the direction of both agency thinking and timing.

The two-day meeting will surely be worthwhile, but can the sequel live up to the original?


Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.

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