Alerts9.12.25
FDA Launches Crackdown on Deceptive Drug Advertising and Initiates Rulemaking
Highlights
- 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.”
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