How Leadership Changes at FDA Impact its Strategy on DTC Drug Advertisements

In September 2025, President Trump issued a statement pushing FDA to more strictly enforce existing regulations regarding DTC advertising for prescription drugs. At the time, the President’s memo argued that FDA was allowing too little information about the drugs to be included in the advertisements, leading in a rise in these sorts of ads.

HHS Secretary Kennedy has also highlighted his concerns with DTC prescription drug advertisements. At the time of the President’s statement, Secretary Kennedy issued a news release in which he said, ““Pharmaceutical ads hooked this country on prescription drugs. We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

Since then, DTC advertisements have remained a talking point among the administration, but very little official action has been taken.

Dan Troy, currently a managing director and expert witness at Berkley Research Group and former lead counsel at FDA under previous administrations, spoke with Pharmaceutical Executive about the issues with regulating DTC advertisements. According to him, it might be harder to restrict these sorts of advertisements, which may not be having the negative impact officials have claimed.

Pharmaceutical Executive: How will leadership changes at FDA impact its efforts related to DTC prescription drug advertisements?
Dan Troy: First of all, I think most observers don't expect a new FDA commissioner to be nominated or confirmed until at least after the midterms. I will add, historically, the FDA commissioner job has not been an easy one to fill.

President Trump says that so many people want the job, and that may be true. But I'll note that when I was in government, the first President Bush, it took 17 months to get Mark McClellan chosen, nominated, and confirmed. And then he was only there for not that long before he went off to CMS, so I don't see a new FDA commissioner very soon.

In general, I think the push against DTC ads doesn't really come from FDA. It comes from Secretary Kennedy, who's got a lot of fish to fry, and I think has been told to focus more on food than on than on other things.

I expect that they'll still continue to send out somewhat more aggressive warning letters and untitled letters than had been the case for the previous 10-to-15 years, but I don't see a guidance or a regulation on the horizon, no matter who's in charge of FDA.