Drug ads face new scrutiny at FDA and on Hill

• But any policy shifts will likely face strong industry resistance and could collide with free speech concerns.

Driving the news: The Food and Drug Administration, in its 2027 budget request this month, asked Congress to give it new authority to crack down on drug ads that lack "fair balance" on the benefits and risks of taking a product.

• The agency wants to address messages that are "frequently misleading and confusing to consumers and patients," per the budget document.
• The FDA has already sent thousands of warnings to manufacturers over ads it deemed "misleading" and moved to close a loophole allowing certain side effects to be listed on a linked website instead of in the ad itself.
• Sens. Roger Marshall (R-Kan.) and Dick Durbin (D-Ill.) urged the agency late last month to use its existing powers to require certain drug ads to undergo reviews before they can be shown.

Between the lines: The FDA cites a 2024 review in the Journal of Pharmaceutical Health Services Research that found only 33% of drug industry social media posts mention potential harms.

• It says 88% of advertisements for top-selling drugs posted by individuals and organizations don't comply with its fair balance guidelines.
• The agency also is grappling with more advertising from telehealth companies that promote prescription drugs without warnings or risks, including hundreds of advertisements for controlled substances.

What they're saying: "We welcome the fact that the FDA is being vigorous about enforcement, and it's long overdue," said Robert Steinbrook, health research group director at the progressive advocacy group Public Citizen.

• "Though we've been critical of many things related to the FDA under commissioner [Marty] Makary, I think this is one of the good things that he's been doing."

The big picture: The issue has crossover appeal to both Health Secretary Robert F. Kennedy Jr.'s "Make America Healthy Again" base and progressives, who each believe that big drug companies are getting away with deceptive and harmful marketing.

• "Pharmaceutical ads hooked this country on prescription drugs," Kennedy said in September. "We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising."
• Senate health committee ranking member Bernie Sanders (I-Vt.) has proposed banning drug ads altogether.

• Sens. Josh Hawley (a populist Missouri Republican), and Jeanne Shaheen (D-N.H.) have introduced a bill that would prevent drug companies from claiming business deductions on direct-to-consumer advertising.

Yes, but: There are legal questions about whether some of the moves would infringe on First Amendment free speech protections.

• Some legal experts say last month's Supreme Court decision that therapists' conversations with patients are constitutionally protected speech showed how justices are approaching First Amendment issues in a health care context.
• While that wasn't a case about advertising, the justices' 8-1 ruling "really emphasized that they think professional speech carries the full weight of First Amendment protection," said Carmel Shachar, faculty director of the Health Law and Policy Clinic at Harvard Law School.
• With drug ads, "the tighter the FDA regulates, the more likely there is to be a First Amendment challenge," she said.

The other side: The pharmaceutical industry argues advertising helps keep consumers informed.

• "Direct-to-consumer (DTC) advertising is designed to provide information backed by fact-based research, so patients are better informed about their health care and treatment options," said Sarah Ryan, spokesperson for the trade group PhRMA.
• "Policymakers should ensure patients have access to the information they need to make health care decisions."

The bottom line: Steinbrook, of Public Citizen, acknowledged new controls on ads could be stymied in court.

• "On the other hand," he said, "if the FDA never tries, it's lost the battle before it starts."