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Creates new rules for drug-related communications on social media and in telehealth: it makes certain social-media influencers and some health-care providers civilly liable for false or misleading drug claims, requires reporting of specified payments tied to drug promotion, and gives the Food and Drug Administration new authority and funding to do market surveillance and hire staff to enforce these rules. The provision also sets deadlines for the FDA to issue guidance, submit reports, and update rules to implement the new obligations.
Amend Section 303 of the Federal Food, Drug, and Cosmetic Act to add paragraph (h) making a social media influencer or health care provider liable to the United States for civil penalties for false or misleading communications about certain prescription drugs, with a penalty amount described in existing paragraph (g)(1) and a similar process to paragraph (g)(2).
Define “false or misleading communications” as advertisements or promotional communications on a social media platform that provide a financial benefit to the person making them and that fail to include the required brief summary information on side effects, contraindications, and effectiveness; exclude bona fide patient care or medical research statements and statements of personal experience, opinion, or value judgment.
Define “social media influencer” as a private individual with perceived credibility or popularity who expresses opinions, recommendations, or experiences on social media to promote or advertise information or products or to induce behavior.
Secretary of Health and Human Services must issue guidance within 180 days after enactment on how paragraph (h) will be administered, including factors for determining whether a communication is false or misleading (types of statements or omissions, whether brief summary alone is sufficient, actions showing compliance, and platform characteristics/speed of dissemination).
Add requirements for telehealth providers by amending section 502(n) of the Federal Food, Drug, and Cosmetic Act; the Secretary must update regulations implementing section 502(n) within 1 year after enactment to reflect these amendments.
Who is affected and how:
Social media influencers and content creators: Directly targeted. They must follow accuracy standards for drug-related content, disclose/report covered payments, maintain records, and face civil penalties for false or misleading drug communications. Smaller creators will likely need to adopt compliance practices or rely on agencies/platforms for clarity.
Telehealth providers and other health-care professionals using digital channels: Required to ensure drug-related communications are accurate and disclosed appropriately in telehealth settings, and to report payments where applicable. This adds compliance and documentation responsibilities for telehealth encounters.
Drug manufacturers and sponsors: May be required to report or disclose transfers of value tied to influencer marketing or telehealth promotion and will face increased scrutiny of promotional pathways.
Social media platforms and intermediaries: Although liability targets influencers and providers, platforms will likely be engaged for recordkeeping, cooperation with FDA surveillance, and may have to adapt policies or reporting support tools to meet agency guidance.
FDA and federal regulators: Will gain new surveillance authority, staffing needs, and rulemaking tasks. The agency must produce guidance and reports within statutory deadlines and implement enforcement mechanisms.
Consumers and patients: Intended to benefit from clearer, more accurate drug information online and in telehealth settings, reducing misleading promotion; could also see changes in the availability or format of influencer-driven health content.
Practical effects and tradeoffs:
Net effect: The provision aims to strengthen consumer protection against misleading drug promotion online and in telehealth, at the cost of added regulatory and recordkeeping burdens on influencers, providers, and industry; much depends on FDA guidance and resources for implementation.
Adds a new subsection (h) to 21 U.S.C. 333 imposing civil liability to the United States for social media influencers or health care providers who make false or misleading communications regarding certain drugs, and defines terms including "false or misleading communications" and "social media influencer."
Amends section 502(n) (21 U.S.C. 352(n)) by adding additional text at the end of that paragraph to impose additional requirements related to telehealth providers (exact inserted text not shown in this section).
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)
Introduced February 20, 2025 by Richard Joseph Durbin · Last progress February 20, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)
Introduced in Senate