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U.S. Moves to Require Full Safety Disclosures in Drug Ads

A White House directive backs stepped-up enforcement.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
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Health and Human Services Secretary Robert F. Kennedy Jr. speaks during a Make America Healthy Again (MAHA) Commission meeting at Dept. of Health and Human Services headquarters in Washington, D.C., Sept. 9, 2025.

Overview

  • HHS and the FDA unveiled a push to restore full, on-air risk disclosures in direct-to-consumer prescription drug advertising on TV and digital platforms.
  • President Trump signed a memo directing the FDA and other agencies to intensify enforcement against misleading promotions across television, websites, and social media.
  • The FDA said it has sent broad compliance letters to drugmakers, with the Associated Press reporting “thousands” of warnings and Newsweek citing roughly 100 cease-and-desist notices.
  • Regulators said they will start reversing a 1997 practice that allowed abbreviated “major-risk” statements, a rulemaking expected to take years and likely to draw legal challenges.
  • PhRMA defended direct-to-consumer ads as protected speech, while former officials and reporting highlighted limits on FDA authority over influencers and telehealth marketers and recent staffing cuts.