• The White House, Department of Health and Human Services (HHS), and Food and Drug Administration (FDA) announced their intent to take aggressive enforcement action to ensure that direct-to-consumer (DTC) prescription drug advertisements are compliant with current laws and regulations.
• The FDA signaled it will initiate rulemaking to modify current DTC advertising regulations and eliminate long-standing policy allowing the most important risk information to be included in broadcast advertisements with adequate provision for dissemination of full approved label information instead of a full summary of all risk information, as was generally required prior to 1997.
• While no new rules have been issued, the FDA announcement suggests they may attempt to reverse a recently implemented regulation requiring broadcast advertisements to include a major statement of risks presented in a “clear, concise, and neutral manner” instead of a comprehensive statement of all labeled risks.

On September 9, the White House issued a Presidential Memorandum directing the HHS and FDA to address what it characterized as misleading DTC prescription drug advertisements. According to the memorandum, “these 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.”

The memorandum directs the Secretary of HHS to “take appropriate action to ensure transparency and accuracy in [DTC] drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements, to the extent permitted by applicable law.”

In response, the HHS and FDA issued press releases outlining the actions being implemented. The FDA announced that, as part of its efforts to implement “sweeping reforms to rein in misleading [DTC] pharmaceutical advertisements,” it had already sent “thousands of letters warning pharmaceutical companies to remove misleading ads” and issued “approximately 100 cease-and-desist letters to companies with deceptive ads.” The letter to industry states that the FDA “intends to take aggressive action and ensure conformity with the law,” and emphasizes its concern that consumers — particularly seniors and social media users — are not receiving a fair balance of risk and benefit information. While the letter to industry was posted with the press release, the FDA has not publicly released the cease-and-desist letters. The reference to “cease-and-desist letters” is inconsistent with any prior FDA enforcement terminology. If the FDA implements this newly announced aggressive enforcement approach, we expect to see a significant increase in untitled letters and Warning Letters related to advertising and promotional compliance compared to previous years which have seen an unusually low number of these types of enforcement actions.

The FDA also announced it will initiate rulemaking to “close the ‘adequate provision’ loophole, which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.” The “loophole” appears to be in reference to the FDA’s “Consumer-Directed Broadcast Advertisements” guidance document, first published in draft form in 1997 and issued in final form in August 1999.  The term “adequate provision” appears in the regulation on prescription drug advertising at 21 C.F.R. § 202.1 but had not previously been defined.  The guidance provided broadcast advertisers with recommendations on presenting a major risk statement and ensuring “adequate provision” for full approved labeling. 

Since that time, the FDA’s Office of Prescription Drug Promotion (OPDP) has conducted extensive research on effective methods to convey safety information to consumers in a manner that maximizes comprehension. Consistent with the research findings, a 2015 OPDP draft guidance proposed allowing DTC ads to present a brief summary of the most important risk information, delivered in a manner most likely to be understood by consumers, instead of including an “exhaustive list of risks” as provided in the prescribing information. Regulations reflecting this approach were implemented at the end of 2024, modifying 21 C.F.R. § 202.1(e)(1) to require sponsors to present a “major statement” of the drug’s risks “in a clear, conspicuous, and neutral manner” in the audio or audio-visual parts of the presentation, or in both audio and text for television ads. The goal of these requirements has been to enhance consumer awareness of the most significant and probable risks associated with prescription drugs.

The HHS press release states that the FDA will return to the pre-1997 policy regarding risk presentation. References to “rulemaking” in the FDA and HHS press releases suggest the FDA may even seek to revise 21 C.F.R. § 202.1, where the term “adequate provision” is used.  Even if the Consumer-Directed Broadcast Advertisements guidance is changed or rescinded, if 21 C.F.R. § 202.1 remains the same, broadcast ads could still rely on “adequate provision” to provide full labeling, although there would be no clarification on what would satisfy this requirement.