HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion

On Tuesday, September 9, the U.S. Food and Drug Administration (FDA) issued a press release announcing “sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements,”¹ while simultaneously sending a templated letter ² to thousands of pharmaceutical companies demanding promotional compliance and approximately 100 so-called “cease-and-desist” letters to companies for deceptive advertising related to specific products. These actions and more are made at the direction of a Presidential Memorandum and in parallel with similar actions by the Department of Health and Human Services taken the same day.³

The following summarizes key aspects of FDA’s new crusade against DTC advertising and promotion:

“Dear Pharmaceutical Company” Template Letter

The templated letter sent across industry reiterates many of the same concerns highlighted in the press release and serves as notice of FDA’s enforcement approach to all drug application holders, directing removal of all non-compliant advertising and demanding compliance for all promotional communications. The issuance of thousands of letters at once is reminiscent of similar enforcement actions taken by the Federal Trade Commission (FTC) against deceptive advertising practices; however, FDA’s letter condemns DTC advertising as a significant public health issue, alleging that it distorts the physician-patient relationship. ⁴

FDA emphasizes the following concerns in the “Dear Pharmaceutical Company” letters:

• Lack of Fair Balance: FDA notes a lack of “fair balance” between drug benefits and risks in drug advertising, even highlighting failure to disclose serious risks and presentation of risk information in a manner that is too difficult for seniors to read or hear.
• Use of Digital and Social Media: FDA expresses particular concern regarding pharmaceutical marketing on digital and social media channels, including undisclosed paid influencer promotion.

These concerns are not new. In fact, most enforcement letters in the past decade have focused on minimization and omission of risk information, and FDA and FTC enforcement against digital and social media (including influencers) has long been a trend. FDA has issued several guidance documents to industry for more than a decade on prescription drug promotion in social media and broadcast advertising. Even FDA’s Office of Prescription Drug Promotion (OPDP) has conducted multiple social sciences studies related to fair balance and disclosures for influencers. Interestingly, FDA did not use its own published studies to support its attack on DTC advertising, but rather relied on a review article based on older and less relevant data.

“Cease and Desist” Letters

The “cease and desist” letters sent as part of this initiative may signal a new approach. It is unclear whether these letters will qualify as traditional Untitled Letters or represent a new category of enforcement letters by FDA. Based on examples available to us, the enforcement letters are not limited to “fair balance” violations or DTC promotion, but also target misleading efficacy claims and promotion to healthcare professionals.

Unlike prior OPDP enforcement letters, which were typically signed by OPDP reviewers and team leaders, the “cease and desist” letters are signed on behalf of the CDER Center Director, George Tidmarsh, likely signaling the increased magnitude and potential consequences of FDA’s enforcement.

The format and style of these letters remind us of older enforcement letters issued by the Division of Drug Marketing and Advertising (DDMAC) (the predecessor to OPDP), in that they lack the organizational structure that became standard in OPDP letters (e.g., “Background” section that identifies product indication(s) and safety, separate sections identifying each type of alleged violation). They also completely omit citations to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations. While the “Conclusion and Requested Action” section remains largely the same, one sentence has been updated consistent with “cease and desist” language. The new letters we have reviewed now state: “FDA requests that [company] take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).”

We anticipate a growing number of enforcement letters beyond this initial set. Indeed, HHS has stated its intent to “continue enforcement activity,” with a “return to the 1990s paradigm of issuing hundreds of enforcement letters each year,” particularly if current enforcement activities do not alter industry approaches.⁵ This will likely be informed by AI and other tech-enabled tools that FDA may use to aggressively and proactively surveil and review drug ads.⁶

Closing the “Adequate Provision Loophole”

FDA and HHS announcements also focus on FDA’s plan to initiate rulemaking to close the “adequate provision loophole,” returning to “the status quo policy pre-1997” for broadcast ads.⁷ It is the government’s position that the “adequate provision” alternative to providing all safety information has been used as a means to “conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.” ⁸

As background, in addition to disclosing significant risks in the “major statement,” FDA regulations require broadcast ads to include a “brief summary” of all necessary safety information unless an “adequate provision” is made for dissemination of the approved product labeling.⁹ The “major statement,” together with “adequate provision” for product labeling, has been the standard approach adopted by industry for broadcast advertisements for decades. FDA guidance recommends that the “adequate provision” include four components: a toll-free phone number, concurrent print ad, website, and direction to speak with a medical professional.¹⁰

Calling “adequate provision” a loophole suggests that pharmaceutical companies have been skirting risk disclosure; however, “adequate provision” has long been permitted by FDA as one of two possible and legal ways to provide risk information to consumers. Removing this option will mean that broadcast ads must include the “brief summary,” which is a more comprehensive list of risks; however, this approach fails to recognize prior research, by OPDP as well as independent researchers, that concluded that consumers are significantly more likely to consider a drug to be less risky when they hear or read the full list of a drug’s potential side effects versus only hearing about the more serious ones.¹¹ Indeed, this research prompted FDA to reevaluate and seek comment on changes to the “major statement” in 2017. Similar research also supported FDA’s draft guidance for the “consumer brief summary” in 2014 and 2015, in which FDA strongly recommends against providing lengthy lists of risks to consumers in advertising and promotion.

Given the practical limitations to including a “brief summary” in a 60-90 second television ad, the planned removal of the “adequate provision” for approved product labeling may be an attempt to eliminate or curtail DTC broadcast ads altogether. This change will also raise new questions about how the “brief summary” should be presented in these ads. FDA only recently finalized rules for the clear, conspicuous, and neutral (CCN) presentation of the “major statement,” which is a requirement under the FD&C Act, but has not specifically addressed the presentation of the “brief summary.”¹²

Observations

There is much to unpack from Tuesday’s announcements and enforcement blitz.

As an initial matter, it is worth noting that, while the Administration’s topline messaging focuses on concerns about DTC advertising, the “cease and desist” letters were not limited to consumer advertisements. Among the examples we reviewed, several cited concerns with promotional materials directed to healthcare professional audiences. Accordingly, companies may want to consider taking a fresh look at all promotional communications for their products to ensure compliance.

Further, although the HHS Secretary has made no secret of his ambition to ban DTC advertising, a direct approach would be untenable under First Amendment precedent. Thus, the Administration appears to want to regulate DTC advertising out of existence, both through aggressive threats of enforcement and by initiating rulemaking to amend the “adequate provision” language in FDA’s regulations. To justify these actions, FDA relies on assertions of public health harm when “patients are not seeing a fair balance of information,” “serious risks are not clearly presented,” and “information is too difficult for seniors to read or hear.” However, FDA cites to dated studies that were conducted before the Agency issued its recent rule establishing standards for what constitutes a clear, conspicuous, and neutral presentation of the major statement. The new requirements went into effect less than a year ago, and it is unclear whether FDA’s data regarding the prevalence of problematic advertisements remains accurate. Likewise, it is unclear whether social science research would justify changing (or, as FDA implies, removing) the “adequate provision” language from the regulation. What would a change mean for the comprehensibility of broadcast advertisements? Could the presentation of the entire brief summary detract from the audience’s understanding of the most serious side effects and contraindications? To justify regulation of sponsors’ speech, FDA must rely on data that demonstrates why its interest is substantial, its solution directly advances that interest, and its solution is no more extensive than necessary to serve that interest. The information relied upon by FDA, thus far, seems to fall short of that constitutional requirement.

How individual pharmaceutical companies respond to the Administration’s attack on prescription drug promotion will, necessarily, be fact-dependent. Some companies may be on strong footing to push back against FDA assertions in the “cease and desist” letters. For instance, if FDA is now citing concerns with promotional materials that were pre-cleared through the advisory process, a company may assert reliance on prior FDA actions. Or, if FDA is asserting that certain promotional statements fall outside the safe harbor provided in FDA’s “CFL” guidance, ¹³ a company may be able to respond with information explaining why the communication meets the standard or why the company’s CFL analysis is reasonable. However, even when a company’s response is legally justified and straightforward, the current Administration’s general hostility to the pharmaceutical industry will likely factor into companies’ decision-making calculus. Because the Administration’s aggressive—dare we say, punitive—actions towards the industry go beyond promotional advertising, the legal and business considerations will remain fluid for the foreseeable future.

¹FDA News Release, “FDA Launches Crackdown on Deceptive Drug Advertising” (Sept. 9. 2025), available at https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising.

²“Dear Pharmaceutical Company” Letter from FDA Commissioner Martin A. Makary (Sept. 9, 2025), available at https://www.fda.gov/media/188616/download?attachment.

³Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs re: Addressing Misleading Direct-To-Consumer Prescription Drug Advertisements (Sept. 9, 2025), available at https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs/. See also HHS Press Release, “HHS, FDA to Require Full Safety Disclosures in Drug Ads” (Sept. 9, 2025), available at https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency.html; and HHS, Press Room, “Fact Sheet : Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies,” (Sept. 9, 2025) (hereinafter “HHS Fact Sheet”), available at https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency-fact-sheet.html#:~:text=Detail%20on%20this%20Action,status%20quo%20policy%20pre%2D1997.

⁴FTC New Release, “FTC Puts Hundreds of Businesses on Notice about Fake Reviews and Other Misleading Endorsements” (Oct. 13, 2021), available at https://www.ftc.gov/news-events/news/press-releases/2021/10/ftc-puts-hundreds-businesses-notice-about-fake-reviews-other-misleading-endorsements.

⁵HHS Fact Sheet, supra note 3.

⁶See “Dear Pharmaceutical Company” Letter, supra note 2.

⁷HHS Fact Sheet, supra note 3.

⁸FDA News Release, supra note 1.

⁹21 C.F.R. § 202.1(e)(1)(i)(B).

¹⁰See FDA Guidance, “Consumer-Directed Broadcast Advertisements” (Aug. 1999), available at https://www.fda.gov/media/75406/download.

¹¹See, e.g., Betts KR, et al., Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements. Research in Social and Administrative Pharmacy (2017), available at http://dx.doi.org/10.1016/j.sapharm.2017.07.015.

¹²See 21 C.F.R. § 202.1(e)(1)(ii).

¹³See FDA Guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling— Questions and Answers” (June 2018), available at https://www.fda.gov/media/102575/download.