FDA's Makary explains 'overdue' pharma ads crackdown

FDA Commissioner Marty Makary has called direct-to-consumer (DTC) advertising of pharmaceuticals a "public health crisis" in an editorial to explain a recent policy change by the federal government.

In the Journal of the American Medical Association (JAMA), Makary claims that the pharma industry has exploited weak regulations and 'flooded' media with promotional, misleading content on their products.

The crackdown was first revealed last week, alongside the release today of a Make America Healthy Again (MAHA) report that alleges people in the US are overprescribed medications. It includes a rollback of a change to DTC ad policy in the 1990s that relaxed the need to include safety information directly in ads, allowing the information to be delivered from other sources, such as websites.

Noting that the US is one of only two countries worldwide that allows DTC advertising of medicines, Makary writes in JAMA that a massive 800% increase in spending by the industry since the rules were loosened has "distorted" the patient-doctor relationship and led to "increased demand for medications regardless of clinical appropriateness."

He claims that the FDA has simultaneously all but abandoned its regulation of advertising, pointing out that the agency sent hundreds of enforcement letters annually to companies in the 1990s but just one in 2023 – and none at all last year.

"Misleading impressions come straight from the ads themselves: glossy scenes of patients laughing, singing, and dancing dominate the screen, while fine print races past with warnings about seizures, addiction, or even death. That is not fair balance – it is a distraction by design," says the editorial.

Last week, the Trump administration said the FDA would send out around 100 enforcement notices and thousands of letters advising pharma companies of the need to make sure DTC ads comply with regulations. The administration went further in President Trump's first term, seeking to have wholesale prices included in all TV ads, although that was blocked in the courts.

The Pharmaceutical Research and Manufacturers Association (PhRMA) industry organisation said in a statement that its members are committed to accurate and responsible advertising that "provides patients with important fact-based, useful and accessible information about potential treatment options."

Makary's piece pledges to close the risk disclosure 'loophole' in ads, but also to address promotions by drugmakers on social media and by online pharmacies and telehealth firms that gloss over safety considerations and just emphasise the benefits of medicines.

In the piece, he singles out a controversial ad by telehealth company Hims & Hers that aired during the Super Bowl this year and highlighted "the benefits of [GLP-1] drugs without any mention of side effects or disclaimers."

"The FDA is not banning prescription drug advertisements – the First Amendment prohibits such action," writes Makary. "But the First Amendment does not protect deceptive and misleading advertisements that have flooded the media, strained the health care system, and driven unnecessary spending that could have been avoided with proper regulatory oversight."

He concludes: "We will no longer tolerate deceptive practices that distort the patient-doctor relationship and waste billions of dollars in health care resources that could be better spent lowering drug prices for Americans."

Photo by Myriam Zilles on Unsplash