Trump Administration Moves to Rein in Direct-to-Consumer Prescription Drug Advertising

The Trump administration’s “Make America Healthy Again” campaign has turned its attention to reining in what it sees as “skyrocket[ing]” levels of “misleading” prescription drug advertising.^_[1] On Tuesday, September 9, 2025, President Trump signed a memorandum directing Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to take appropriate action to “ensure transparency and accuracy in direct-to-consumer prescription drug advertising,” including by increasing the amount of information related to drug side effects contained in these advertisements.^_[2] As a consequence, the pharmaceutical industry should expect to see increased scrutiny of its direct-to-consumer advertising.

The administration’s critiques of prescription drug advertising date back to FDA guidance, issued in the late 1990s after public hearings on the topic, that relaxed requirements regarding the disclosure of drug side effects in direct-to-consumer promotion.^_[3] Before these changes, regulations required broadcast advertisements touting the specific benefits of advertised drugs to contain a “brief summary” of all side effects and contraindications.^_[4] This brief summary was often prohibitively long for inclusion in broadcast advertisements, however, which meant pharmaceutical companies rarely advertised via television, radio, or phone.^_[5] The 1990s revisions allowed broadcast advertisements to present the most important risk information in a “major statement” and then relegate the rest of any side effect and contraindication information elsewhere—for example, with healthcare providers, toll-free telephone numbers, print ads, or websites—provided that the advertisement directed consumers to the location for this information.^_[6] As a result of this “adequate provision” allowance, broadcast prescription drug advertising became far more common.^_[7]

It is this adequate provision “loophole” that the Trump administration seeks to close. In a press release following President Trump’s memorandum, the FDA announced its intention to engage in rulemaking to eliminate the adequate provision allowance and return to the standard that required prescription drug broadcast advertisements to include disclosure of all drug side effect and risk information.^_[8] According to Secretary Kennedy Jr., “[o]nly radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”^_[9]

The FDA also signaled that it will abandon the “overly cautious approach taken by previous administrations” and will more strictly enforce current regulations aimed at ensuring the clarity of direct-to-consumer drug advertising.^_[10] This includes sending cease-and-desist letters to pharmaceutical companies it sees as running deceptive or misleading prescription drug advertisements, as well as writing to all pharmaceutical advertisers in order to warn of the agency’s increased enforcement efforts.^_[11] The FDA also said it will expand its oversight to social media platforms, where paid influencers promote drugs without proper disclosures.^_[12]

Short of an outright ban on direct-to-consumer prescription drug advertisements, these efforts—and particularly the elimination of the adequate provision allowance—may result in far fewer broadcast drug commercials.^_[13] The Trump administration’s efforts in this space are expected to be met with First Amendment challenges.^_[14]

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