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Adds a statutory definition of “direct-to-consumer advertising” to the misbranding provisions of the Federal Food, Drug, and Cosmetic Act and makes that definition apply to drugs approved under section 505 (new drug approvals) or licensed under section 351 (biologics). The change takes effect 30 days after enactment and applies to covered drugs regardless of when they were approved or licensed.
Adds a new paragraph (hh) to section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352). The new paragraph contains at least two subparagraphs labeled (1) and (2).
Paragraph (hh)(1) text (as provided): "If it is a drug approved under section 505 or licensed under section 351 of the Public Health Service Act, and subject to section 503(b)(1), and the holder of the approved application under section 505 or of the license under such section 351 has conducted direct-to-consumer advertising of the drug within the most recent 30-day period."
Paragraph (hh)(2) defines the term direct-to-consumer advertising, for purposes of this paragraph, as "any promotional communication targeting consumers, including through television, radio, print media, digital platforms, and social media, for purposes of marketing such a drug."
The amendment made by subsection (a) takes effect 30 days after the date of enactment of this Act and applies with respect to any drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act, regardless of when the drug was approved or licensed.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Last progress June 12, 2025 (8 months ago)
Introduced on June 12, 2025 by Bernard Sanders
Primary impacts fall on drug sponsors, advertisers, and digital platforms that present or host consumer-directed promotional materials. Drug manufacturers and biologics sponsors will need to review all consumer-facing promotional content to determine whether it meets the new statutory definition and adjust content, claims, or presentation to reduce misbranding risk. Advertising agencies and platform operators that place or host ads may need to update contracts, vetting and moderation processes, and compliance checks. Consumers may see changes in how prescription products are advertised (language, format, disclaimers), though the amendment does not itself require new disclosures. The FDA is likely to interpret and apply the definition in its enforcement work; this may prompt guidance or increased regulatory letters if the agency narrows or clarifies its view of DTC ads. The provision imposes regulatory compliance tasks on private firms but does not create federal spending obligations or new state/local mandates. Legal challenges or litigation could arise around the statute’s interpretation, especially for borderline communications (e.g., reminders, disease awareness materials, or professional-targeted messages with incidental consumer exposure). Overall administrative burden is moderate and focused on legal/compliance teams within affected companies and on agency interpretation.
Updated 1 week ago
Last progress July 22, 2025 (6 months ago)