DTC Perspectives’ News


To Ban or Not to Ban? The Future of DTC Under Kennedy’s Leadership

November 19, 2024 by Bob Ehrlich0
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I am more concerned than last week about regulatory actions limiting DTC marketing. The nomination of Robert Kennedy Jr. to head HHS gives me the jitters. Excuse me for changing my more optimistic tune from last week when RFK Jr. was to be the advisory Health Czar. Running HHS gives him much more power than just being a Trump consigliere.

The question of banning DTC hinges on one main legal argument. Does the government have a legitimate public health reason to ban DTC? That reason must outweigh the first amendment right to commercial speech. The courts have generally sided with free speech over restrictions on advertising. The ban DTC movement has been active since 1997 after FDA allowed DTC on television.

What is the compelling public interest to ban DTC? Advocates for a ban say DTC creates inappropriate demand exposing consumers to risks outweighing the benefits. There is no evidence of that demand being inappropriate. Drug efficacy is variable, and it is true some patients do not always benefit. The fact that not all drugs work in all patients is a long way from causing a public health issue.


The courts would likely rule that free speech outweighs the potential public health reason for a ban. After all, these DTC drug products are FDA approved and heavily regulated. Ban proponents cite the ban on cigarette advertising as a precedent. That is a legal product but clearly proven to cause public harm. DTC for approved drugs has not shown such public harm even if it has increased prescribing. In fact, there are solid research studies that show increased disease and drug awareness is a positive result of DTC.

Let’s assume Mr. Kennedy is advised by his legal staff an outright DTC ban is unconstitutional. Are there other steps he can take? It might be that a partial ban could be instituted to return to pre-1997 regulation. The courts might accept that having DTC available in print, Point of Care, and digital channels would be a fair compromise. Congress could also revive the idea of a tax penalty on DTC by forbidding deductibility of DTC advertising. FDA could also require pre-clearance of all ads and be tough on approval. They could also issue more untitled and warning letters. Reviewers could be pressured to find violative language in more ads. The net is Kennedy could make executing DTC ads a real chore.

It will be up to the lobbyists to make the case to keep things as they are. Mr. Kennedy will have lots of other health priorities more important than DTC. The industry has made its DTC case with Congress successfully since 1997. I am concerned but still bet against draconian moves by a Kennedy-led HHS.

Author

Bob Ehrlich


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