Paths Forward in the Wake of FDA’s “Crackdown” on Prescription Drug Ads

The Trump Administration and the Department of Health and Human Services (“HHS”) recently announced a “crackdown” on direct-to-consumer (“DTC”) advertising of prescription drugs, resulting in over 100 “cease-and-desist” letters issued in a single day. This coincided with the Make America Healthy Again (“MAHA”) Commission’s release of its Make Our Children Healthy Again Strategy, which included a call for increased oversight and enforcement of alleged violations of DTC prescription drug advertising laws. On the same day, President Trump issued a memorandum ordering HHS to take “appropriate action to ensure transparency and accuracy in [DTC] prescription drug advertising,” including by increasing the amount of risk information to be provided in advertisements and ordering FDA to “take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions, and otherwise ensure truthful and non-misleading information in [DTC] prescription drug advertisements.”

Also that same day, FDA issued a news release announcing that it sent “thousands of letters warning biopharmaceutical companies to remove misleading ads,” and that it issued “approximately 100 cease-and-desist letters to companies with deceptive ads.” The release asserted that FDA has taken an “increasingly lax and reactive” enforcement approach over the last few decades and that the Agency would “no longer tolerate such deceptive practices” and would aggressively deploy its available enforcement tools, including artificial intelligence (“AI”) and other tech-enabled tools for surveillance.

This announcement was accompanied by, among other things, an HHS news release on the same day, opinion pieces authored by the Commissioner of Food and Drugs in JAMA and the New York Times, and HHS’s own ad stating that, through MAHA, the President and HHS Secretary “are taking deceptive drug ads head on” and “standing up to Big Pharma.” It further asserted that that “MAHA may cause healthier living, fewer chronic diseases, and lower drug costs.” and included visuals of a family petting a dog, blowing bubbles, and running with a kite, with an accompanying disclaimer of “side effects.”

Since these initial announcements, FDA has released 107 warning and untitled letters targeting DTC ads.¹ Here, we describe our analysis of the DTC letters, potential challenges to FDA’s actions, and considerations for biopharmaceutical manufacturers moving forward.

Overview of the DTC Letters

In addition to the generic letter that appears to have been sent to “all application holders,” directing them to ensure that their DTC prescription drug advertising complies with applicable laws, as of today, a total of 107 warning and untitled letters has been publicly released. More than half were issued for advertising of compounded drugs, and the remainder for advertising of FDA-approved drugs and biological products.

Most of the letters for FDA-approved products targeted DTC television ads, and a limited number were for earned media (including broadcast news interviews), sponsored links, a webpage, and a print ad. 

Notably, our analysis of citations in the letters revealed that they focused on alleged violations for both safety- and efficacy-related presentations.

Most of the risk-related citations were for presentations in ads that included audio or visual elements, alone or in combination, which were alleged to interfere with viewer comprehension. Some citations also alleged that ads otherwise failed to comply with the recently finalized rule on “clear, conspicuous, and neutral” presentation of risk information in broadcast ads, omitted important risk information, or that when presented, risk information did not appear in the order of severity or was minimized.

As for benefit-related violations, most citations alleged that ads claimed greater magnitude or duration of benefit associated with the drug. Many also alleged violations for claims that treatment will positively impact a patient’s health-related quality of life or social/emotional functioning, and some also targeted claims related to immediacy of benefit, mechanism-of-action, and indicated population or use.

Legal and Regulatory Issues Raised

Many of the recent letters raise issues that have long been viewed as settled in light the limitations the First Amendment places on FDA’s ability to regulate truthful and non-misleading information about products under its jurisdiction. FDA’s enforcement efforts may therefore face challenges from industry and other stakeholders, particularly if this action represents the start of a sustained increase in enforcement or signals a long-term shift in the Agency’s interpretations of requirements for DTC drug ads.

At the outset, it has long been noted that prescription drug ads have many important public health benefits. For example, they raise awareness about diseases or conditions and patients who view them may be more likely to seek medical care, attend follow-up appointments, and adhere to prescribed dosing regimens.

In that context, the First Amendment fundamentally protects “works which, taken as a whole, have serious … scientific value, regardless of whether the government … approve[s] of the ideas these works represent.”² To the extent the speech targeted by the warning and untitled letters represents scientific speech regarding issues of public interest—or even commercial speech impacting “the fields of medicine and public health, where information can save lives”³—challengers may argue that FDA cannot make the showing required to overcome First Amendment protection. In practical terms, challengers may point to the reality that failure to recognize First Amendment protection for speech with scientific or public health value would fundamentally erode biopharmaceutical companies’ constitutional right to engage meaningfully in the public discourse—on the basis of speaker identity and speech content alone.

Challengers may also argue that FDA’s recent enforcement is inconsistent with limitations of its statutory authority. In one potential approach, challengers may assert that the crackdown impermissibly attempts to expand the Agency’s reach beyond the authority granted by Congress. Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA may regulate “labeling” and “advertising,” as defined by the statute and applicable FDA regulations. Challengers may contend that communications not fitting squarely within these definitions, such as earned media and certain social media communications, fall completely outside FDA’s jurisdiction.⁴ In a second potential approach, challengers may focus on the tension between the letters and certain regulatory provisions, such as the “clear, conspicuous, and neutral” requirement,⁵ as well as inconsistencies with FDA’s prior interpretation and enforcement in this area.

These are by no means the only challenges available in light of the increased Agency scrutiny of DTC advertising. For example, there has been speculation regarding whether AI was involved in preparation of certain letters released as part of the crackdown, particularly given the significant reduction in force earlier this year and its reported impact on the Office of Prescription Drug Promotion (“OPDP”), the office that has historically reviewed promotional materials and issued warning and untitled letters for the vast majority of FDA-regulated drugs and biological products. Involvement of AI may be problematic given that FDA’s regulation of advertising and promotion requires a constitutional analysis, is nuanced, and does not lend itself to black-and-white decision-making. It remains to be seen what additional avenues industry and other stakeholders may leverage as they respond to the recent developments in FDA’s enforcement patterns.

Next Steps for Industry

It remains uncertain whether FDA’s recent wave of letters will be followed by a sustained shift in enforcement activity. Given that both the Presidential Memo and FDA’s announcements touch upon the industry’s spending on advertising and/or drug pricing, some of the current activity may reflect broader policy debates around these topics, including most-favored nation proposals and related discussions with industry. This use of DTC enforcement as part of a wider policy context does not necessarily indicate a long-term change in FDA’s approach.

Nevertheless, companies should recognize that the baseline level of scrutiny on consumer-facing promotion has increased. The letters highlight areas that the Administration currently may view as most problematic, and those themes are unlikely to disappear from enforcement considerations at least in the near term. Going forward, companies should reassess existing portfolios with an eye toward the issues FDA has highlighted. In addition, companies should generally assess their own particular policies and approaches to DTC promotion in view of the increased scrutiny of such communications and the possibility that additional issues could be a focus of enforcement in the future.

¹ On September 25, 2025, FDA released ten more untitled letters targeting promotional materials directed to health care professionals.

² Miller v. California, 413 U.S. 15, 34 (1973).

³ Sorrell v. IMS Health, 564 U.S. 552, 566 (2011). 

⁴ See 21 U.S.C. § 321(m) (defining “labeling” to include written, printed, or graphic matter “(1) upon any article or any of its containers or wrappers, or (2) accompanying such article”); 21 C.F.R. § 202.1(l)(1) (describing “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems”).

⁵ 21 U.S.C. § 352(m); see 21 C.F.R. § 202.1(e)(1).