S 483 Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.
Responsibility in Drug Advertising Act of 2025
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- to-consumer drug advertising.
Summary
The bill restricts direct-to-consumer advertising of newly approved drugs, prohibiting such advertising for the first three years after a drug receives FDA approval, including advertising on social media platforms. The FDA Secretary may waive this prohibition during the third year if the drug sponsor requests a waiver and the Secretary determines that direct-to-consumer advertising would provide affirmative public health value. After the initial three-year period, the Secretary may prohibit direct-to-consumer advertising of a drug if post-approval studies or other evidence indicates the drug has significant adverse health effects. The bill requires the FDA to revise its advertising regulations within one year of enactment and applies to drugs approved within one year before the bill's enactment and to future drug approvals.
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)
2 cosponsors
- Sen. Kaine, Tim [D-VA] (D-VA)
- Sen. Welch, Peter [D-VT] (D-VT)
Actions (2)
- Feb 6, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Feb 6, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE SENATE OF THE UNITED STATES
February 6 (legislative day, February 5), 2025
Mr. King (for himself, Mr. Kaine, and Mr. Welch) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
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>
Comments