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Trump’s plan for a drug advertising crackdown faces many hurdles

Trump’s plan for a drug advertising crackdown faces many hurdles

Associated Press
2025/09/29
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But the FDA has long struggled to defend its actions against drug promotions in court. And reworking some of its key regulations — including those governing TV advertising — could take years.

Here’s a look at the administration’s plans and some of the hurdles that may lie ahead.

A promise for more FDA warnings after years of legal setbacks

But rather than individual notices citing specific violations, the FDA shared a generic letter that it sent to drugmakers, instructing them to bring “all promotional communications into compliance.”

The FDA’s press release noted that such warnings have fallen dramatically in recent years, with only one issued in 2023 and none in 2024.

Former FDA officials say that reflects two trends. First, the drug industry has abandoned many of the most egregious tactics deployed in the early 2000s, including the use of distracting sounds and visuals that often drew attention away from drug warnings and side effect information.

Additionally, the FDA has repeatedly settled legal cases challenging its authority to police drug promotions. The agency often declines to pursue such cases due to the risks of losing in court, which could create legal precedent eroding its power.

Looking ahead, recent Trump administration job cuts have slashed staffing in the FDA’s drug advertising division, which handles warning letters.

One major proposal by the administration involves reversing a nearly 30-year-old FDA rule.

The FDA said this week it will begin the process to eliminate that practice, calling it a “loophole” used to “conceal critical safety risks.”

But the FDA rulemaking process usually takes years — sometimes more than a decade — with multiple opportunities for public comment and revision.

If the FDA tried to skip steps or rush, drugmakers could challenge the process in court.

“Truthful and nonmisleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement,” PhRMA, the industry’s leading trade group, said in a statement Wednesday.

Influencers and other newer promoters may be beyond FDA’s reach

The agency has long struggled to oversee those promotions, because FDA advertising rules only apply to drug companies.

Social media influencers who are paid to endorse or promote products are supposed to clearly disclose that relationship. But that requirement is overseen by the Federal Trade Commission.

And in some cases, influencers aren’t being paid by anyone: They promote products in hopes of landing future endorsement deals.

Companies that connect patients to so-called compounded drugs say they are not subject to FDA rules because they are not traditional drug manufacturers.

A Senate bill introduced last year would bring influencers and telehealth companies clearly under FDA’s jurisdiction, requiring them to disclose risk and side effect information. But the legislation has not advanced or received a hearing.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.