United States: FDA Proposes To Delay Off-Label "Intended Use" Rule

Last Updated: January 16 2018
Article by Stephen J. McConnell

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and device regulation can be just as important, if not considerably more important, than whatever current political claptrap is getting all the bandwidth. Drug and device availability and innovation actually affects people's lives regularly and profoundly. Despite the typical claims of plaintiff lawyers at trial, the FDA is not a paper tiger. The FDA's actions and attitudes have a huge impact on the industry. Those attitudes and actions can oscillate with election results. For example, in 2016, the FDA issued 15 warning letters to drug and device manufacturers regarding alleged false or misleading advertising. 2017 saw only three such warning letters and one untitled letter. Change is in the air. We did not see any coverage this weekend of the FDA's January 12, 2018 statement "on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the 'intended use' of medical products." Take a look at the FDA's announcement here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592358.htm. If you are a completist, here is the full proposal of delay from the Federal Register: https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or. Whatever else you might think about the Trump vs. Obama administrations, this rethink is an example of the new FDA leadership doing the right thing.

The background is a bit byzantine. In the waning days of the Obama administration, on January 9, 2017, the FDA issued a Final Rule on "Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses.'" That "clarification" was both a trick and a double-cross. The tobacco features were a distraction from the FDA's desperate attempt to save its constitutionally-suspect enterprise of clamping down on communications about off-label use of drugs or devices. As we have described several times before, the FDA's power to punish off-label promotion rests on a regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. Got that? The regulations supporting this tortured logic have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA's interpretation of "intended use" and its efforts to shut down truthful medical-science communications about potential benefits from off-label use. In a 2015 proposed rule, the FDA proposed striking the language from the regulations permitting the FDA to consider a manufacturer's mere knowledge of actual use as evidence of intended use. Good news, right? We thought so. But not so fast. The FDA's January 9, 2017 proposal reversed course, retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded "totality of the evidence" standard. A constitutionally frail regulatory regime looked like it was about to become even worse – even more vague, over broad, and chilling.

We bemoaned this ugly turn of events, as did many other legal commentators. Not to take undue credit, but we suspect that the eruption of the legal blogosphere on this issue had a beneficial result. The incoming Trump administration placed a brief hold on new regulations, and then delayed the "intended use" regulation to March 19, 2018 so that comments could be received and considered. Did comments pour in? Yes they did. Fifteen comments came in. Two addressed the tobacco issues. (That portion of the regulation will go forward.) Thirteen criticized the new broadening of the types of evidence that could be considered in determining intended use. One of those comments was written by PhRMA. We summarized that excellent, persuasive comment here. Read as a whole (or, if you prefer, the totality of the circumstances), the comments made a strong case that the proposed final rule violated the First Amendment, was so vague as to implicate due process, interfered with the practice of medicine, departed from existing statutes, cases, regulations, and past practices, and would have negative health implications. You all spoke up, and the FDA listened. The bottom line is that the FDA is now proposing to "delay until further notice" the portions of the final rule amending the FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses. The FDA will receive comments on this proposal through February 5, 2018. If you haven't spoken up on this very important issue, speak up now. How many times in your life and career can you take a position that actually makes a difference, and that both saves lives and free speech?

We sometimes spend time on this blog grousing. Not this time. Well done, FDA. Well done, all of you who contributed to the debate.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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