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Responsibility in Drug Advertising Act of 2025
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- to-consumer drug advertising.
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer advertising of newly approved drugs. It prohibits direct-to-consumer advertising, including on social media, of newly approved drugs for 3 years following approval, though the FDA Secretary may waive this prohibition in the third year if advertising would have affirmative public health value. After the 3-year period, the Secretary can prohibit advertising if the drug is found to have significant adverse health effects based on post-approval monitoring and studies. The FDA Secretary must revise advertising regulations within 1 year to implement these restrictions.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
Money behind the sponsor
Top reported contributors to Rosa L. Delauro’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Rosa L. Delauro → · Outside spending →
Actions (2)
- Feb 7, 2025 Referred to the House Committee on Energy and Commerce. · house
- Feb 7, 2025 Introduced in House
More bills on these subjects (8)
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Similar bills (6)
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Text versions (1)
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Full text
IN THE HOUSE OF REPRESENTATIVES
February 7, 2025
Ms. DeLauro introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- to-consumer drug advertising.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Responsibility in Drug Advertising Act of 2025”.
SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—
(1) in section 301 (21 U.S.C. 331), by adding at the end the following: “(jjj) The conduct of direct-to-consumer advertising of a drug in violation of section 506M.”; and
(2) in chapter V, by inserting after section 506L (21 U.S.C. 356l) the following:
“SEC. 506M. DIRECT-TO-CONSUMER DRUG ADVERTISING.
“(a) Prohibitions.—
“(1) First 3 years.—
“(A) In general.—Subject to subparagraph (B), no person shall conduct direct-to-consumer advertising, including on a social media platform, of a drug approved under section 505(c) before the end of the 3- year period beginning on the date of such approval.
“(B) Waiver.—The Secretary may waive the application of subparagraph (A) to a drug during the third year of the 3-year period described in such subparagraph if—
“(i) the sponsor of the drug submits an application to the Secretary pursuant to subparagraph (C); and
“(ii) the Secretary, after considering the application and any accompanying materials, determines that direct-to-consumer advertising of the drug would have an affirmative value to public health.
“(C) Application for waiver.—To seek a waiver under subparagraph (B), the sponsor of a drug shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
“(2) Subsequent years.—The Secretary may prohibit direct- to-consumer advertising, including on social media platforms, of a drug during the period beginning at the end of the 3-year period described in paragraph (1)(A) if the Secretary determines that the drug has significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, any clinical or observational studies, or any other appropriate resource.
“(b) Regulations.—Not later than 1 year after the date of the enactment of this section, the Secretary shall revise the regulations promulgated under this Act governing drug advertisements to the extent necessary to implement this section.
“(c) Rule of Construction.—This section shall not be construed to diminish the authority of the Secretary to prohibit or regulate direct- to-consumer advertising of drugs, including on social media platforms, under any other provision of law.
“(d) Effective Date.—This section applies only with respect to a drug approved under section 505(c) on or after the date that is 1 year before the date of enactment of this section.”. <all>
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