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 the pharmaceutical industry and layoffs among regulators tasked with leading the effort.
President Donald Trump last week signed a memo 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 Kennedy, who 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.
Trump’s directive instead tells the FDA to use current laws to ensure “transparency and accuracy” in all ads.
The FDA, however, 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.
The FDA kicked off its effort last week saying it was issuing “thousands” of warnings to drugmakers over inaccurate or misleading ads.
Rather than individual notices citing specific violations, however, 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.
The FDA also 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 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 last week said it will begin the process to eliminate that practice, calling it a “loophole” used to “conceal critical safety risks.”
The FDA rulemaking process, however, 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 pharmaceutical 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.
FDA Commissioner Marty Makary also suggested his agency will be more aggressive about policing ads on social media platforms such as Instagram, on which 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.
In some cases, influencers aren’t being paid by anyone: They promote products in hopes of landing future endorsement deals.