News update
WASHINGTON (AP) — Health Secretary Robert F. Kennedy Jr. and other administration officials are vowing a crackdown on deceptive drug ads, but the effort is likely to face multiple headwinds, including pushback from industry and layoffs among regulators tasked with leading the effort.
President Donald Trump signed a memo Tuesday that directs the Food and Drug Administration and other agencies to step up enforcement against ubiquitous prescription drug ads on TV, websites and social media.
The industry’s multibillion-dollar marketing efforts have long been a target for Kennedywho previously suggested banning all pharmaceutical ads from TV. That step would have almost certainly been struck down by federal judges, who have long accepted advertising as a First Amendment-protected form of speech.
Instead, Trump’s directive tells the FDA to use current laws to ensure “transparency and accuracy” in all ads.
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.
News update A promise for more FDA warnings after years of legal setbacks
The FDA kicked off its effort Tuesday evening saying it was issuing “thousands” of warnings to drugmakers over inaccurate or misleading ads.
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 form letter is different from typical FDA warning letters, which usually cite specific issues with company advertisements that run afoul of FDA rules and lay the groundwork for future legal action.
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.
News update A plan to curb TV ads could take a very long time
One major proposal by the administration involves reversing a nearly 30-year-old FDA rule.
Until the late 1990s, TV drug advertisements were impractical and prohibitively expensive because FDA regulations required drugmakers to list each medication’s risks and side effects. A 1997 shift allowed companies to briefly summarize that information and point viewers to more complete information on websites, in print ads or elsewhere.
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.
For example, new guidelines finalized last year that require clearer and simpler language in drug ads took more than 15 years to develop and implement.
If the FDA tried to skip steps or rush, drugmakers could challenge the process in court.
For its part, the industry maintains that TV ads are a way to educate and empower consumers.
“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.
News update Influencers and other newer promoters may be beyond FDA’s reach
FDA Commissioner Marty Makary also suggested his agency will be more aggressive about policing ads on social media platforms like Instagram, where drugmakers often partner with patient influencers or doctors.
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.
The FDA has also been under pressure to crack down on advertisements from newer specialty pharmacies and telehealth companies. A Super Bowl ad from one company drew scrutiny earlier this year for promoting unofficial versions of weight loss drugs, touting their benefits without listing any of the risks or side effects. Disclosing that information is an FDA requirement.
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.
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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.
