/>iLate yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with deceptive ads[,]” as well as initiating rulemaking to “close the ‘adequate provision’ loophole[.]” Concurrently, the White House issued its own memorandum, commanding the Secretary of Health and Human Services to take actions “to the extent permitted by applicable law.”
As we have stated on this blog previously, an uptick in enforcement has been long expected, given Dr. Makary’s statements in the media and at various conferences, but the sweeping nature of this pronouncement goes much further. HHS posted a deep dive on FDA’s tripartite approach, and HHS, at least in theory, is not focused solely on TV ads. The focus goes further to “close digital loopholes” and target influencer partnerships, sponsored content “across all platforms,” algorithm-targeted ads, AI-generated content, and more. As noted in the FDA press release, in addition to the letters going out, FDA’s enforcement focus will “will be based upon its existing authority, though the Agency will take a more expansive reading of its authorities in contrast to the overly cautious approach taken by previous administrations.”
So, two big picture industry risks are at play here—enforcement and rulemaking. On the enforcement side, the first question is—to whom will the letters go? We expect the form letter from the press release will be sent to just about every drug company in FDA’s database, plus other entities like telehealth and/or pharmacies, as Dr. Makary on an Instagram post also mentioned “online pharmacies” that promote drugs “sometimes with no mention of side effects at all.” The second question is—what is it going to look like? The untitled/warning letter tools are always at FDA’s disposal—perhaps what FDA means in the press release by “cease-and-desist” letters. It is unclear what FDA means by closing “digital loopholes” in social media promotion, but that probably dovetails with its focus on letter writing for DTC ads. Expect FDA to nitpick just about everything, but not to create new theories of enforcement—to be sure, there is a lot of questionable drug advertising out there. There is also a chance that FDA works with FTC on these initiatives, particularly on the influencer/telehealth/pharmacy side.
On the rulemaking side, we largely expect challenges and thus time to work through the courts. If the LDT final rule is a reasonable guidepost, this could get pushed a year or so. The logical conclusion of removing the rule would be a death knell for the drug advertising industry, at least on TV. We expect special interests to battle this one out, especially given the airtime for drug ads on TV across all networks.
Ultimately, the key question is whether this enforcement will have real teeth or serve instead as a public relations initiative. This looks to us more like the latter than a tectonic industry shift—layups on the warning letters because that’s always been within FDA’s regulatory toolbelt and tossup on the rulemaking—likely to win the former, and if you lose the latter, the goal is still achieved. It remains to be seen, and in the meantime, we will be working through these letters and strategizing steps forward.
