On September 9, 2025, the Department of Health and Human Services (“HHS”) and Food and Drug Administration (“FDA”) announced a series of measures to address “misleading” direct-to-consumer prescription drug (“DTC”) advertisements. The measures include (1) rulemaking to rescind the “adequate provision” requirement, which permits manufacturers to include a general statement of risk alongside a webpage or publication and 1-800 number to access the full product labeling, (2) enhanced enforcement of DTC violations, and (3) expanded oversight of prescription drug advertising on social media. Although these measures address DTC advertising broadly, they appear targeted at broadcast and social media advertisements.
Background
Before the announcements from HHS and FDA, President Trump issued a brief “Memorandum for the Secretary of Health and Human Services [and] the Commissioner of Food and Drugs,” ordering the HHS Secretary and FDA Commissioner to take steps to address alleged “misleading” prescription drug advertising. In the memorandum, the President asserted that DTC advertisements can “mislead the public about the risks and benefits, encourage medications over lifestyle changes, inappropriately intervene in the physician-patient relationship, and advantage expensive drugs over cheaper generics.” HHS and FDA built on this theme in a press release issued shortly after the publication of the memorandum which noted, among other points, that “[t]he proliferation of simplistic pharmaceutical ads on television and digital media distorted physician prescribing habits and patient decisions.” The press release also included statements from HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary underscoring the Administration’s resolve to address allegedly misleading DTC advertisements.
Summary of the Administration’s Actions
The Administration announced three immediate actions to address allegedly misleading prescription drug DTC advertising:
- Rescinding the “Adequate Provision” Requirement: HHS and FDA announced that they are initiating rulemaking to remove the “‘Adequate Provision’ Loophole.” This statement refers to a provision in 21 CFR 202.1(e)(1)(i)(B) that has been in place since 1969 and requires manufacturers to include in broadcast advertising “a brief summary of all necessary information related to side effects and contraindications, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation” (emphasis added). In subsequent guidance published in draft form in 1997 and finalized in 1999, FDA clarified that a manufacturer fulfills the “adequate provision” requirement by including a major statement “conveying all of the product’s most important risk information” and providing “reasonably convenient access to the advertised product’s approved labeling” including through access to a 1-800 number, website, concurrent print advertisements, and a disclosure that pharmacists or physicians may provide additional product information. See FDA, Guidance for Industry Consumer-Directed Broadcast Advertisements at 2-3 (Aug. 1999). If the “adequate provision” regulation is rescinded, manufacturers would need to provide “a brief summary of all necessary information related to side effects and contraindications” in advertising, including broadcast and social media advertisements.
- Enforcement Actions for DTC Advertisement Violations: FDA and HHS leadership criticized a decrease in FDA’s DTC violation enforcement actions since the 1990s. In a fact sheet, FDA and HHS noted that “[e]nforcement letters plummeted from over 130 annually in the late 1990s to just three in 2023.” FDA and HHS proposed two steps to address these issues:
- General warning on noncompliant advertisements: FDA announced that it had sent “every single sponsor of an approved drug or biologic (several thousand companies)” a letter “putting them on notice that FDA will be actively enforcing violations of the law[] and directing them to remove all non-compliant promotional materials from the market.” In a copy of the letter posted online, FDA Commissioner Marty Makary directs companies to “remove any noncompliant advertising and bring all promotional communications into compliance.” The letter is addressed to pharmaceutical manufacturers generally and does not allege any specific violations.
- Enforcement letters for false and misleading advertising: FDA also announced that it would be issuing “dozens of enforcement letters related to false and misleading advertising.” FDA and HHS said that the basis for these letters is “existing authority,” although they clarified that FDA “will take a more expansive reading of its authorities in contrast to the overly cautious approach taken by previous administrations.” In a separate FDA press release, the Agency stated that it sent “approximately 100 cease-and-desist letters to companies with deceptive ads.” These cease-and-desist letters do not appear to have been publicly posted as of the publication of this update. It is unclear whether they constitute the “dozens of enforcement letters” or whether they are in addition to the enforcement letters.
- Increased scrutiny of social media advertising: Finally, FDA and HHS announced that they would “close digital loopholes by expanding oversight to encompass all social media promotional activities.” Examples of promotional activities include (1) influencer partnerships and sponsored content, (2) algorithm-driven targeted advertising and “dark ads,” (3) AI-generated health content and chatbot interactions, (4) platform-specific promotional strategies to evade detection, and (5) emerging digital technologies and promotional methods. In a separate FDA press release, the agency noted that it is “already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.”
Implications for Stakeholders
While certain implementation details remain uncertain, the newly announced DTC advertisement policies could have significant implications for pharmaceutical manufacturers. In particular, eliminating the “adequate provision” requirement and requiring a brief summary with full risk information in broadcast advertisement could significantly curtail such advertisements. The proposed changes to FDA’s regulations for prescription drug advertising likely would impact animal drugs as well since the regulations and underlying statutory provisions generally apply equally to human and animal drugs. At the same time, many question remain unanswered including the possible timeline for such changes and the legality of these actions.
Covington has been actively advising stakeholders on the implications of the Administration’s new DTC policies. If you would like to discuss how the changes to DTC advertisement affect your organization, please contact the authors of this alert.
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