Published on Sep 15, 2025
The White House’s Make America Healthy Again (MAHA) Commission, led by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., is expected to release a “Make Our Children Healthy Again” policy plan tomorrow. The strategy may include a crackdown on direct-to-consumer (DTC) pharmaceutical advertisements, a practice Secretary Kennedy has criticized in the past.
While an outright ban on DTC pharmaceutical ads is very unlikely, the administration could seek to tighten safety information reporting requirements or more strictly enforce existing laws around drug advertising, according to lawyers, health policy experts and pharmaceutical industry professionals. However, it’s unclear how much more leeway there is for federal agencies to regulate drug ads and to what extent ramped-up enforcement would change the way drugmakers operate, sources told The Capitol Forum.
An earlier leaked draft of the forthcoming policy strategy states that several federal agencies—including the Food and Drug Administration, HHS, the Federal Trade Commission and the Justice Department—will “increase oversight and enforcement under current authorities for violations of direct-to consumer prescription drug advertising laws.” The agencies will “prioritiz[e] the most egregious violations including by social media influencers and DTC telehealth companies and demonstrating harm from current practices (including dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms),” the document said.
In line with the MAHA Commission’s goals, congresspeople across the aisle have proposed measures to restrict DTC advertising. For instance, Senator Bernie Sanders (I-VT) introduced a bill that would fully ban the practice, with the House proposing its own version of the ban. Another bill introduced by Rep. Gregory Murphy (R-NC) would prevent drugmakers from writing off advertising from their taxes.
Sources said an outright ban on DTC advertisements, whether it comes from Congress or the Trump administration, would almost certainly be challenged as unconstitutional under the First Amendment.
“You’re not going to be able to get rid of advertising and promotion wholesale,” Kyle Faget, partner and a health care and life sciences lawyer with Foley & Lardner, told The Capitol Forum. “What I think you could see is a strengthening of enforcement around things like important safety information.”
The FDA issued guidance in 1997 clarifying the rules around direct-to-consumer advertising and establishing a “fair balance” standard for risk information. When advertising, companies must share a “major statement” of a drug’s most important risks, the FDA said, and these ads must provide consumers with a reasonable way to access the full prescribing information for a drug. In 2023, the FDA finalized standards for the “clear, conspicuous and neutral” presentation of a drug’s major risk statement.
Under the first Trump administration, HHS attempted to pass rulemaking that would require drugmakers to disclose drug costs in their advertisements, but the policy was struck down by a federal judge who said HHS did not have that authority.
Given the MAHA Commission’s interest in targeting DTC ads and the slim odds of success for an outright ban, the administration will likely seek to more strictly interpret and enforce existing FDA guidance around “fair balance” advertising and risk statements without seeking to rewrite any laws, sources said. But even these efforts could face challenges under the First Amendment and Administrative Procedure Act.
“There might be an effort to require more safety information in consumer advertisements […] but you can imagine that looking a few different ways, needing to make risks more prominent than they currently are, having to make more prominent severe risks versus mild safety events,” Michael DiStefano, assistant professor in the Department of Clinical Pharmacy at University of Colorado Anschutz, told The Capitol Forum. “Black box warnings could be made more prominent than perhaps they already are.”
Bob Ehrlich, chairman and CEO of a pharmaceutical marketing company called DTC Perspectives, said “the industry feels pretty good that here’s not going to be a ban because of the constitutional issues,” though, “on the other hand, [the Trump administration] hasn’t been shy to test these things in court.”
Even if the MAHA Commission announces policy steps that are mild compared to an outright DTC ad ban—such as heavier enforcement and stricter interpretation of existing laws—policy and law experts questioned how much additional authority FDA and other agencies have to wield.
For instance, if the FDA were to issue more consent decrees against pharmaceutical companies, that too could be disputed under free speech rights, one expert told The Capitol Forum.
The FDA’s legal authority to regulate the advertising activity of telehealth companies, a goal outlined in the draft policy document, is also questionable because these companies are arguably providers rather than manufacturers, Faget of Foley & Lardner said. However, the FTC could step in and regulate telehealth companies in some limited circumstances, she said.
“FTC could arguably say, ‘Hey, look, that’s misleading,’” Faget said. “That might be an avenue for Kennedy to put pressure on the FTC to regulate in that way. But I don’t think you’re going to be able to see complete evisceration of advertising and promoting of pharmaceuticals, not without there being serious litigation.”
Tongil “TI” Kim, associate professor of marketing at The University of Texas at Dallas’ Naveen Jindal School of Management, agreed that while the FDA “oversees the accuracy and balance of drug ads, particularly around safety disclosures, and could tighten or more aggressively enforce requirements for risk communication,” the FTC could step in elsewhere because it “has authority over false or misleading claims more broadly, including those made in digital ads or by influencers.”
HHS also has tools such as the Anti-Kickback Statute (AKS) and False Claims Act (FCA) to indirectly regulate the promotion of products and services covered by federal health care programs. The Justice Department collaborates with HHS to bring such cases.
It’s possible the Trump Administration will simply use the threat of DTC advertising regulation as leverage to accomplish other pharma-related goals, such as lowering drug prices, several sources told The Capitol Forum.
Industry impacts. Whether the MAHA Commission takes any steps that shift industry behavior remains to be seen, given the high likelihood of pushback. Some sources predicted a shift towards more disease-focused, rather than drug-specific, advertising.
“If DTC advertising were not to be banned outright but became more restricted and regulated, then the campaigns may become more unbranded,” Nirmal Vemanna, principal product specialist for healthcare and life sciences at Tealium, told The Capitol Forum, not speaking on behalf of his company. “Rather than talking about Ozempic and Mounjaro or any other medication for which you see the ads today, campaigns will focus more on creating disease awareness.”
According to Vemanna, “I would likely guess new regulations aiming for less emotional advertising and more fact-driven and disease awareness [advertising], similar to a European model, but the specifics of how they would shake out, that remains to be seen.”
Some sources said no policy that would shift pharmaceutical advertising in a significant way is likely to pass. Others said the threat of heightened enforcement, or measures meant to make drug advertising more detailed and cumbersome, could lead to some changes in industry.
“One can imagine the FDA making disclosure requirements more demanding, which would make 30-second TV spots less appealing for pharmaceutical companies—especially for drugs treating high-risk conditions,” Kim said. This could encourage a shift away from digital formats, Kim said, and “[b]eyond DTC, stricter rules could also encourage companies to reallocate budgets toward professional promotion, including journal advertising, free samples, and detailing.”
Vemanna said that “if DTCs restrictions do come about, we will likely see a considerable if not significant shift in ad spending that will favor provider enablement and education,” adding that “there will be less ROI [return on investment] associated with DTC advertising if more restrictions were to come down.”
Vemanna said increased regulation of DTC drug advertisements could present an opportunity for companies that offer a targeted digital platform through which drugmakers can engage prescribers: “As [drugmakers] pivot from mass DTC advertising to precision [engagement of] HCPs [health care providers], the more these and other technology vendors that can help pharma brands companies with HCP engagement will continue to benefit.”
Doximity (DOCS) and Medscape (WBMD), two players in this space, did not respond to immediate requests for comment on the matter.
In response to a request for comment on future policy measures, the possibility of legal challenges, and the authority held by HHS and other agencies to regulate pharma advertising, a HHS spokesperson told The Capitol Forum, “Until it is released, any claims about the contents of the forthcoming report are speculative.”
