DTC Ad Enforcement to Increase Under Trump: Panel
The incoming Trump administration is likely to increase FDA enforcement of regulations governing direct-to-consumer (DTC) promotions, according to FDA watchers in a panel discussion at the Food and Drug Law Institute’ annual conference in Washington. Commenting on HHS secretary-nominee Robert F. Kennedy Jr.'s opposition to DTC advertising, Morgan, Lewis & Bockius partner Jacqueline Berman said companies should have a strong promotional review committee process in place now. “Companies should definitely make sure that their substantiation for [promotional] statements are strong, that they’re supported by the evidence and they’re supported by a study because I think that’s one area that we probably may see some more enforcement than we have had in the last administration,” she warned.
Berman noted FDA’s past trajectory of enforcement around advertising and promotional activities has been focused on “digging very deeply into the data and seeing if it's substantiated. And I think we’ll continue to see that in more traditional promotional enforcement, and I think we’ll continue we’ll see that in the DTC space, especially with some of the statements that tend to be made in DTC ads just to make them consumer-friendly and that there’s going to be much higher scrutiny of those.”
Former FDA and HHS lawyer (Obama Administration) and now-managing director of the health practice at Waxman Strategies Jeremy Sharp told FDLI that he agreed that there will probably be some “lean in” toward more enforcement in the DTC space that could lead to litigation. He observed that the next Trump administration appeared to have officials who could have some conflicts of interest regarding certain products that FDA might normally take enforcement action on. “I think there will probably be enormous internal pressure on the agency to go easy on those kinds of things and I think that’ll be an interesting thing to see how that interacts with any kind of consistent policy view of wanting to enforce in this space.”
Former FDA deputy chief of staff (under Robert Califf and Scott Gottlieb) and now-principal of consultant group Eliquent Life Sciences Kalah Auchincloss noted that opposing DTC advertising would be an unusual position for RFK Jr. to take in a Republican administration, and so there could be some tension on this from industry. Berman, however, noted that the political appointees being selected are not as industry-friendly as in the prior Trump administration, and “so I think that just the whole way of approaching the agency is probably going to change.”
Panel moderator and APCO Worldwide healthcare president Wayne L. Pines dismissed the notion of RFK Jr. following through with his campaign promise to ban DTC ads, mainly because of Fox News and the amount of advertising revenue it and other TV networks rely on. “I think that once that is called to Kennedy, and even Elon Musk’s, attention, they will immediately back off of that.”
The panel members all agreed that whatever enforcement changes occur it would take time before they are implemented. Auchincloss said it is likely that FDA commissioner-nominee Marty Makary could be approved by the Senate by May, so it will likely be business as usual until sometime after that. She and others seemed to view Makary as a good pick, and said he balances out the other Trump health picks like RFK Jr. and his deputy Jim O’Neill, an investor and close associate of billionaire Peter Thiel. She said Makary is a respected public health professor and “he at least says that he follows the evidence… He’s got some ties to the compounding world, which will be interesting to see how that plays out. But I do think he's at least guided by the science, and maybe he can be a potentially moderating force, probably not a Gottlieb, but maybe sort of in that vein.”