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This bill would limit drug ads that go directly to the public. It would stop companies from advertising a newly approved drug to consumers for the first three years after approval, including on social media. During that third year, the Health and Human Services Secretary could allow an ad only if the drug company asks for a waiver and the Secretary decides the ads would help public health. After the three-year period, the Secretary could also block ads for a drug if new evidence shows the drug has serious harmful effects. The bill would require the government to update its drug advertising rules within one year.
No direct-to-consumer advertising would be allowed for a drug during its first 3 years after approval.
This ban would cover ads on social media and other forms of public advertising aimed at consumers.
The Secretary could grant a waiver in the third year if the drug maker applies and the ad is judged to have a positive value for public health.
After the 3-year period, the Secretary could still ban ads for a drug if post-approval studies, safety reports, or other evidence show major health risks.
Official Summaries
Responsibility in Drug Advertising Act of 2025
This bill prohibits direct-to-consumer advertising of new drugs during the first three years following their approval by the Food and Drug Administration (FDA). Direct-to-consumer advertising includes advertising via social media.
Upon request from a drug’s sponsor, the FDA may waive the prohibition during the third year following a drug’s approval if it determines that the direct-to-consumer advertising of the drug would have an affirmative value to public health. Conversely, the FDA may prohibit such advertising beyond the three-year period following approval if it determines that the drug has significant adverse health effects based on post-approval studies, adverse event reports, and other appropriate resources.
The prohibition applies to new drugs approved beginning one year before the bill’s enactment.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 483 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 483
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
to-consumer drug advertising.
_______________________________________________________________________
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.''.
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