FDA Pushes For Broader Powers To Curb Misleading Direct To Consumer Drug Advertising

Building on the Trump administration’s efforts to crack down on deceptive direct-to-consumer (DTC) prescription drug advertising, the Food and Drug Administration (FDA) has recently requested new authority from Congress to more strictly regulate DTC drug advertisements.¹ As detailed in the FDA’s fiscal 2027 budget request, the proposal would amend Section 502 of the Federal Food, Drug, and Cosmetic Act to provide the agency greater authority to address misleading advertising that adversely affects consumers and patients.²

Under the FDA’s proposal, a drug would be deemed misbranded if a DTC advertisement for the product “lacks fair balance and creates a misleading impression regarding FDA approval, the scope of the FDA-approved indication(s) and the limitations of use, or the drug’s efficacy and benefits, including by making or suggesting overstated representations that are not supported.”³ In addition, compounded drugs would be classified as misbranded if their advertisements are false or misleading — specifically, if they fail to clearly note that the products have not been evaluated for safety, effectiveness or quality by the FDA; make unsupported claims regarding safety and effectiveness; are misleadingly compared to FDA-approved drugs; or omit necessary risk information.⁴

Since President Trump’s September 2025 directive to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to enhance transparency and accuracy in DTC prescription drug advertisements, the FDA has issued thousands of letters warning pharmaceutical and telehealth companies to remove misleading advertisements.⁵ Thirty of those letters targeted telehealth firms over advertising of compounded GLP-1 products and followed a letter from Sens. Dick Durbin, D-Ill., and Roger Marshall, R-Kan., that urged the agency to exercise its authority and require pre-submission review of certain DTC pharmaceutical advertisements of GLP-1 medications prior to last year’s Super Bowl.⁶ The same senators introduced the Protecting Patients from Deceptive Drug Ads Act last year, which sought to instruct the FDA to issue warning letters and fines to combat false and misleading prescription drug advertisements by both telehealth companies and social media influencers.⁷ The bill, S.652, has been referred to the Committee on Health, Education, Labor, and Pensions.⁸

Collectively, these developments confirm that pharmaceutical advertising remains a focus of the executive branch and underscores the importance of pharmaceutical advertisers to stay ahead of the changing regulatory landscape.

Footnotes

1. U.S. Food & Drug Admin., Dep’t of Health & Human Services, Fiscal Year 2027 at 16, https://www.fda.gov/media/191778/download?attachment.

2. Id.

3. Id.

4. Id.

5. See Presidential Memoranda, “Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs (Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements)” (Sept. 9, 2025), https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs/; Press Release, U.S. Food & Drug Admin., “FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s” (Mar. 3, 2026), https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s.

6. See Press Release, supra note 5; Press Release, Dick Durbin, U.S. Senator for Illinois, “Durbin, Marshall Draw FDA Attention to Misleading Drug Commercial Set to Run During Super Bowl” (Feb. 7, 2025), https://www.durbin.senate.gov/newsroom/press-releases/durbin-marshall-draw-fda-attention-to-misleading-drug-commercial-set-to-run-during-super-bowl.

7. See Protecting Patients from Deceptive Drug Ads Act, Text, S.652, 119th Cong. (2025), https://www.congress.gov/bill/119th-congress/senate-bill/652/text.

8. See Protecting Patients from Deceptive Drug Ads Act, All Actions, S.652, 119th Cong. (2025), https://www.congress.gov/bill/119th-congress/senate-bill/652/all-actions.