Roadblocks and Hurdles for DTC Prescription Drug Ad Oversight: Q&A with Dan Troy

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.

Click here for the video version of this interview!

Pharmaceutical Executive: Why is there a push at FDA to increase oversight on DTC prescription drug ads?
Dan Troy: Secretary Kennedy and a number of other people (I guess one would characterize them in the Maha movement) believe that DTC ads over medicalize our society, and that they push people to take medicines that perhaps they shouldn't.

I'm not sure. There's a lot of data behind that view, and in fact, there's a lot of data about the good that DTC ads do. But DTC ads, which can be annoying, let's all acknowledge that, are exceedingly unpopular and are often blamed wrongly for drug prices being too high.

There's a concern about drug ads on television and on social media, because there's a sense that they may not give the full picture of risks. Although, as we all know, there are lots and lots of risks that are disclosed in DTC ads (which is occasionally one of the things that can make them so annoying).

Also, there's a lot of suspicion of social media. Some of it is well warranted, and there's a sense that people are uniquely susceptible to being influenced by social media.

Pharmaceutical Executive: What impact would strict oversight on prescription drug ads have on pharma companies?
Dan Troy: The question really is what kind of increased oversight there would be. There are constitutional limits on what government can do here. So, although the mandate from leadership called to ban DTC ads on TV and social media, that's just not possible given the First Amendment.

There's a grudging acknowledgement of that. I know that the lawyers at FDA and HHS understand the First Amendment constraints. So, obviously companies pay attention to what FDA does and says, but there are again very important limits on what FDA is going to be able to do in this space.

Pharmaceutical Executive: What is the timeline for action to be taken by FDA?
Dan Troy: My sources tell me that the idea of a notice of proposed rulemaking on DTC ads to try and close the ostensible loophole (which is actually a recognition that the First Amendment will not allow a de facto ban on such truthful, not misleading, scientifically substantiated communications) is dead.

This administration, especially at FDA, they're not doing rulemaking. I think they recognize the average rulemaking at FDA has been taking from conception to notice of proposed rulemaking to comments to final getting all the way through the process about an average of eight years.

I was told by the recent outgoing head of the Office of Policy that there's just no rule making going on. They've tried to ramp up enforcement by sending out a bunch of letters, many of which I think have been rightly ignored. I don't think this administration is going to take any kind of significant action that's going to have any lasting effect on DTC ads.

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.