The U.S. Food and Drug Administration (FDA) announced it is changing its approach to direct-to-consumer (DTC) drug advertisements after a directive from a White House Memo instructing FDA and HHS to “to ensure transparency and accuracy.” The agency says it plans to close a “loophole” that allows drug sponsors to omit a brief summary of risk information from broadcast ads in certain circumstances that were prescribed in FDA guidance first issued in 1997. Simultaneously, FDA sent thousands of letters warning pharmaceutical companies, which demand that they evaluate their compliance with the statute. Below we analyze the impact of these Trump administration statements – including whether they effectively constitute a rescission of agency guidance – and we consider what additional enforcement actions may be coming down the pike.
Late on Tuesday, the White House issued a Memo directing the U.S. Health and Human Services Department (HHS) to “take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription 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.” At the same time, HHS issued a press release announcing “a major reform of pharmaceutical advertisements that will require drug companies to include full safety warnings during their direct-to-consumer ads.”
FDA to end “adequate provision” exception, targeting social media
The White House Memo directs 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 direct-to-consumer prescription drug advertisements.” Simultaneously, FDA issued a press release that “announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.”
FDA further announced that it is “initiating rulemaking to close the ‘adequate provision’ loophole created in 1997,” which FDA claimed “drug companies have used to conceal critical safety risks in broadcast and digital ads.” FDA issued draft guidance in 1997 (that was finalized in 1999) to interpret how manufacturers might meet the requirement in 21 C.F.R. 202.1 to provide a brief summary of risk information in broadcast advertising unless “adequate provision” is made to provide the drug’s labeling in connection with the broadcast advertisement. This guidance allows companies to offer additional risk information through the PI which can be made available through a variety of sources, including a toll-free telephone number or website address.
As FDA explained in a fact sheet issued alongside its press release, the Federal Food, Drug, and Cosmetic Act (FDCA) requires manufacturers, and distributors to include in all advertisements and other descriptive printed matter for prescriptions drugs to include “information in brief summary relating to side effects, contraindications, and effectiveness.” Broadcast ads for prescription drugs generally must include the major side effects and contraindications and “contain 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.”
Targeting social media in particular, FDA said it will close digital loopholes by expanding oversight to encompass all social media promotional activities, including:
- Influencer partnerships and sponsored content across all platforms.
- Algorithm-driven targeted advertising and “dark ads.”
- AI-generated health content and chatbot interactions.
- Platform-specific promotional strategies designed to evade detection.
- Emerging digital technologies and promotional methods.
FDA rulemaking or guidance rescission forthcoming?
FDA has not expressly withdrawn its guidance documents on this matter, nor does the language in Tuesday’s statements clearly convey an intent to do so. Instead, FDA stated that it will engage in “rulemaking” to close the adequate provision “loophole.” Given the history of First Amendment litigation surrounding FDA misbranding enforcement actions, any future rulemaking could draw intense scrutiny including litigation.
Next steps
This drug advertising “crackdown” comes after agency actions in recent years have signaled heightened enforcement scrutiny of promotional materials that FDA deem to be false or misleading, as we predicted online here. Meanwhile, a Strategy Report published by the Make America Healthy Again (MAHA) Commission this week stated: “FDA, HHS, the Federal Trade Commission (FTC), and Department of Justice will increase oversight and enforcement under current authorities for violations of direct-to-consumer (DTC) prescription drug advertising laws.”
Whether FDA will initiate any further “enforcement” is, of course, unclear. As FDA considers other enforcement action, it will also need to contend with the litigation risk related to First Amendment protections. In addition, there is a major question whether FDA has the capacity to escalate its enforcement activities, given that CDER’s Office of Prescription Drug Promotion (OPDP) was significantly affected by government layoffs in April.
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