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 appears to be the first FDA attempt to directly patrol online platforms that have long maintained they’re not subject to traditional drug advertising rules. In response to a request for comment, Javier Lacayo, a spokesperson for Hims & Hers, said that the company looks forward to engaging with the FDA and that it had “conducted a comprehensive review of our promotional materials related to compounded treatments to ensure they meet FDA standards and clearly communicate that these products are not FDA-approved.”
Other letters from the FDA focus on claims depicted in ads or imagery that overstate benefits. Commercials that got flagged included one for Pluvicto, a prostate cancer treatment made by Novartis. The FDA called out the company for misleading viewers, namely by “suggesting that despite trying and failing previous prostate cancer treatments, perseverance combined with taking Pluvicto will definitively result in a successful outcome in treating prostate cancer.” (A relevant study found the tumors shrank or disappeared in 49 percent of patients.)
In another example, the FDA issued the drug manufacturer BridgeBio a letter, asserting a commercial for its drug Attruby suggests it will “broadly improve a patient’s overall quality of life when this has not been demonstrated.”
FDA letters normally demand a written response within 15 working days. But as of Friday afternoon, no response letters had been posted. (Undark also reached out repeatedly to Novartis and BridgeBio for comment on the FDA letters, but did not receive a response. Hims & Hers confirmed they did provide a response to FDA but did not comment on whether it had been publicly posted.)
The wave of notices does seem to suggest stricter regulatory scrutiny. But as Harvard University professor of medicine Aaron Kesselheim and epidemiologist Katelyn Jetelina noted in an post on the Substack Your Local Epidemiologist, “Warning letters nearly always just result in the company withdrawing or adjusting the advertisement without any fines or additional penalties — oftentimes months after the ad has already been widely disseminated.”
In an email to Undark, Paul Schiff Berman, a professor of law at George Washington University, seemed to underscore this point, noting that “the letters are not themselves either a rule or an enforcement action.”
In addition to attempts at enforcing current regulations, the FDA’s next proposed step is to initiate rulemaking aimed at closing the adequate provision rule, according to a September press release from the agency. Rulemaking is the process by which government agencies create regulations that have the force of law — and it can take months or longer. This typically includes a 60-day period during which the public may comment following a draft proposal.
“Warning letters nearly always just result in the company withdrawing or adjusting the advertisement without any fines or additional penalties — oftentimes months after the ad has already been widely disseminated.”
FDA’s efforts to restrict DTC drug advertising through rulemaking are also likely to face legal hurdles. Alan Minsk, a partner at the law firm Arnall Golden Gregory LLP, and chair of its Food and Drug practice, was quoted in an article in Law360 saying that the FDA has previously lost First Amendment challenges when regulating pharmaceutical promotion. He added that “The agency might learn from those cases in how it creates any new rules or requirements.”
In an email to Undark, Minsk said that challenges to laws that restrict free speech seem likely, and that they might emanate from the industry and groups such as the Washington Legal Foundation, which advocates for free-market principles. The WLF, a nonprofit public-interest law firm and policy center, hinted recently that it might, indeed, sue the FDA.
George Washington University’s Berman echoed similar points in a message to Undark: “When and if the FDA either issues a new rule about DTC ads or begins an enforcement action based on an allegedly unlawful ad, then there will surely be a legal challenge to the rule or enforcement action based on the U.S. Constitution.”
Perhaps to preemptively address legal challenges, the FDA framed the matter in a fact sheet as one related to “the core government interests of protecting the public from deception and protecting public health.” And in his JAMA opinion piece, FDA commissioner Makary asserted that DTC advertising has “evolved into a public health crisis.” (In response to a request for comment, Emily Hilliard, a spokesperson for HHS, which houses FDA, noted that media responses may be delayed to the government shutdown but provided a link to a September news release. She did not reply to subsequent inquiries.)
In an article published in June, one trade journalist considered “piecemeal regulatory tweaks” to be the government’s most realistic tack. But it’s far from clear whether the rulemaking that FDA intends to pursue will be viewed as piecemeal. And what happened during the first Trump administration may give the current FDA some pause: The administration at that time attempted to require that drug makers disclose list prices higher than $35 in television spots — a seemingly small change. A court injunction, however, foiled their plans.
Given the probable legal impediments, this could explain why marketing policy experts appear unperturbed by the FDA’s policy announcements. At a recent panel organized by the trade outlet Fierce Pharma, James Potter, executive director of the Coalition for Healthcare Communication — a free-speech advocacy group representing health care industry interests — urged health care marketers to simply “keep doing what you’re doing.”
As for those FDA letters? Potter called them “glorified press releases.”