Late last month, the U.S. Department of Health and Human Services, which is overseen by Secretary Robert F. Kennedy Jr., drew a line in the sand over direct-to-consumer advertising by pharmaceutical companies: In a post on X, the agency declared that drug ads “can push people to take drugs they don’t actually need. Americans often end up harmed instead of helped.”

That’s why, the post continued, President Donald Trump and Kennedy “are taking action.”

The most immediate evidence of those efforts came the previous week, in the form of a presidential memorandum on what the administration views as “misleading” direct-to-consumer (DTC) prescription drug ads. The same day, HHS and the Food and Drug Administration released a joint press release outlining that drug makers would now be required to substitute the abbreviated disclosures they’ve used since 1997 with full safety warnings, including conditions or situations that make taking the drug unsafe.

Despite the change in stance, however, it’s unclear if or when Americans will see fewer ads — or even ones that reflect the memo’s objectives. Legal challenges will almost certainly stymie the Trump administration’s most aggressive actions, and the history of pharmaceutical advertising in the United States is one of uneasy tension between consumer interest and corporate free speech.

The U.S. is one of just two wealthy countries where DTC ads for prescription drugs are legal. Estimates vary on how much money major drug companies spend on advertising. An upper bound estimate by The Campaign for Sustainable Rx Pricing, a coalition that promotes lower drug prices in the U.S., put the figure at nearly $14 billion, which includes the cost of promoting drugs to physicians. And recent data shows that in the first quarter of 2025, drugmakers spent approximately $729 million to air commercials for just the top 10 brands, up nearly 30 percent from the same period in 2024.

DTC commercials tout treatments for autoimmune conditions, cancer, cardiovascular diseases, weight loss, and dermatological disorders, among many things. Defenders of such advertising have typically argued that it alerts consumers to therapeutics and the conditions they treat, but critics claim the practice contributes to the use — and perhaps over-use — of higher-cost drugs over generics or less expensive alternatives. Echoing these concerns, Trump’s FDA Commissioner, Marty Makary, has argued that DTC ads have led to inappropriate demand for medications and an increase in drug spending.

The FDA’s Office of Prescription Drug Promotion regulates DTC advertising by monitoring commercials once they’re broadcast. Current regulations strive to ensure that the information contained in advertisements is not “false or misleading” and presents a “fair balance” of drug risks and benefits. This fair balance principle goes back several decades.

Some 40 years ago, the FDA commissioner under President Ronald Reagan expressed reservations about direct-to-consumer prescription advertising and called for a voluntary moratorium so the agency could study the issue. But after further evaluation, the agency ruled that DTC drug ads were permissible provided they included a “brief summary” of the FDA-authorized label.

However, that rule was harder to satisfy in television and radio ads than it was in print. So in 1997, the FDA instituted a policy called the adequate provision rule. This allows commercials on television and radio to meet fair-balance standards by combining a statement of major risks with directions for accessing full prescribing information elsewhere.

Despite the change in stance, however, it’s unclear if or when Americans will see fewer ads — or even ones that reflect the memo’s objectives.

The FDA now says it will move to close what it sees as a “loophole” through rulemaking to revert DTC drug ads to pre-1997 standards. This could result in fewer commercials, as it may be prohibitively expensive for companies to include lengthy disclaimers in ads. The agency also seeks to expand its oversight to “encompass all social media promotional activities.”

Trump’s memorandum also calls for stepped-up government enforcement to ensure “fair, balanced, and complete” commercials. To this end, the FDA sent roughly 100 cease-and-desist letters last month to pharmaceutical firms and telehealth providers, accusing them of deceptive advertising. The agency made notices available — which varied in types of alleged infraction — to the public.

Many letters were directed to companies for advertising and marketing compounded versions of glucagon-like peptide-1 (GLP-1) agonist drugs for weight loss. Specifically, the FDA alleged misbranding or failure to adequately disclose risks associated with the medications. In one letter to the telehealth platform Hims & Hers, which sells compounded versions of certain obesity drugs, the FDA deemed content on the company’s website to be “false or misleading,” due to language claiming its products for obesity contain “the same active ingredient” as FDA-approved treatments. In fact, the formulations sold by Hims & Hers are produced by specialty compounding pharmacies and aren’t FDA-approved.

Separately, in an opinion piece published in the Journal of the American Medical Association, FDA Commissioner Makary cited a Super Bowl ad put out by the company in February, which failed to disclose side effects. At the time, Hims & Hers declared that, as an entity that connects patients to prescribers but does not manufacture pharmaceuticals, it is exempt from including lengthy read-outs of risks and side effects.

This story was published by Undark on October 27, 2025. It is republished with permission.