Protecting Patients from Deceptive Drug Ads Online Act

This bill regulates false or misleading online communications about prescription drugs, targeting social media influencers and health care providers. It imposes civil penalties for such communications, requires reporting of payments related to drug promotion, and authorizes market surveillance of prescription drug advertising on social media.

Sec. 2, Regulation of certain communications regarding prescription drugs: This section amends the Federal Food, Drug, and Cosmetic Act to make social media influencers and health care providers liable for civil penalties if they knowingly or recklessly make false or misleading communications about a prescription drug on social media for financial benefit, or fail to include required brief summary information on side effects, contraindications, and effectiveness. Exceptions include statements made in bona fide patient care or medical research, and statements of personal experience, opinion, or value judgment. The Secretary of Health and Human Services must issue guidance within 180 days on administering this provision, including factors for determining false or misleading communications.

Sec. 2, Additional requirements for telehealth providers: This section amends the definition of 'manufacturer, packer, or distributor' for prescription drug advertising requirements to include entities that bring together patients and prescribers via telehealth. The Secretary must update related regulations within one year. Private communications between a licensed practitioner and a patient are exempt.

Sec. 2, Reporting requirement: Payments from drug manufacturers to health care providers, telehealth companies, or social media influencers, and payments from health care providers to social media influencers for promoting or communicating about a covered drug, must be reported to the Secretary and made publicly available under the Sunshine Act.

Sec. 2, Market surveillance of prescription drug advertising or promotion: The Secretary may conduct market surveillance of prescription drug promotion on social media, including using AI to analyze public communications, hiring additional staff, and establishing a task force with the Federal Trade Commission. The Secretary may notify drug manufacturers of communications that fail to include required brief summary information. Reports to Congress are required within 2 and 4 years, and enforcement actions must be made public. $15 million per year is authorized for fiscal years 2025 through 2029.

Sec. 2, Social media influencer: Defines 'social media influencer' as a private individual with perceived credibility or popularity who expresses opinions on social media to an audience, including in a manner conveying trust or expertise, for promoting or advertising products or inducing behavior.

Sec. 2, Severability: If any provision of the Act is held invalid, the remainder of the Act and its amendments shall not be affected.