If there has been one regulatory constant over the years, it has been the FDA's persistent position that off-label promotion is bad and that companies that engage in it are acting illegally. Since we first encountered this agency attitude as relatively young lawyers in the 1990s, we've thought that this position was unconstitutional under the First Amendment. But the FDA has steadfastly maintained that restrictions on off-label promotion are necessary to incentivize manufacturers of regulated products to bring new uses of approved products to the FDA for approval.
When we first started on our First Amendment crusade in support of truthful off-label promotion, people thought we were crazy. They might be right, but not because of this position. Now, after seismic shifts in constitutional law, it's the FDA that has to be concerned about the viability of its off-label promotion positions.
And now, apparently, the FDA no longer views those incentives as all that necessary.
Why?
Because the FDA has decided to go into the off-label promotion business itself.
You heard that right.
Our jaws dropped when we saw an FDA Press Release, dated December 5, 2019, announcing the availability of a new "Internet-based repository" called "CURE ID." Developed in collaboration between the FDA and an agency we'd never heard of, the National Center for Advancing Translational Sciences, CURE ID collects information on off-label use success stories from physicians. It "will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs."
When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs. . . .
Health care professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient. The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions.
(12/5/2019) FDA Press Release (emphasis added). "Repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway." Id.
But CURE ID does more than let the FDA collect data about successful off-label uses. The FDA will also use CURE ID to promote those uses to the medical community generally – as a forum for physicians to come together to discuss promising off-label uses:
Health care professionals can browse from a collection of cases that have already been documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally.
Id. (emphasis added).
Thus, the FDA now not only recognizes the clinical benefits of off-label use itself, but it recognizes – and intends to encourage – the promotion of such uses to the medical community generally. So we extend a rather belated "welcome to the club" to the FDA. The FDA's jumping aboard the truthful off-label promotion bandwagon can only benefit the public health.
But we would be remiss not to point out the elephant that isn't in the chatroom. What about our clients, the regulated manufacturers of prescription medical products? Oddly the FDA press release is entirely silent as to the role of the only entities that the Agency formally regulates.
Will company medical staff be able to participate in CURE ID? Our clients are already obligated to report adverse events that occur in connection with off-label use of their products. Shouldn't they be equally required – or at least encouraged − to report successes as well? We hope so. A reporting system that focuses solely on risks, while ignoring benefits (whether the use is on or off-label) would inevitably produce skewed results that inhibit medical innovation. After all, the same "emerging signals" that might reflect risk, can just as well reflect benefits.
CURE ID is designed to "harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases." (12/5/2019) FDA Press Release. With that in mind, we encourage our clients to register their medical staff so they can participate in these vital discussions. Here's a link for registering with CURE ID. After all, drug and device companies have numerous opportunities to interact with physicians and thus to learn about beneficial off-label uses.
But if this kind of anecdotal evidence is worth sharing with the medical community, isn't the more rigorously developed data that our clients create through clinical investigations even more worthy of being freely disseminated to the same professional audience? After all, in all other aspects of FDA regulation, epidemiology trumps case studies.
With the FDA now engaging in truthful off-label promotion itself, we are still waiting for the FDA formally to remove its ban on regulated entities doing the same. Not only is CURE ID beneficial to the public health, but it also starkly demonstrates how the current regime is a speaker-based prior restraint against the First Amendment-protected scientific speech of manufacturers.
Finally, for you litigators – imagine the fun you can have cross-examining so-called FDA "experts" like Kessler with this latest FDA development. Kessler's views on off-label promotion – and many other aspects of FDA regulation – are simply obsolete. With apologies to Oldsmobile, it's not your father's FDA anymore. To the extent that Kessler (and others) advance as ostensibly common-law standards a view of FDA regulation at variance with actual FDA practice, there's a conflict preemption argument to be made.
This article is presented for informational purposes only and is not intended to constitute legal advice.
