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This bill would limit direct-to-consumer advertising of prescription drugs, including ads on social media. In general, drug makers could not advertise a drug to the public during the first 3 years after the drug is approved. The Health and Human Services Secretary could allow an exception in the third year if the drug company applies and the Secretary decides the ads would help public health. After those 3 years, the Secretary could also block advertising if the drug is later found to have serious health risks. The bill would require the government to update its advertising rules within one year and would make breaking these rules a violation of federal drug law.
- Drug ads aimed at consumers would be banned for the first 3 years after FDA approval.
- This ban would include ads on social media platforms.
- The Secretary could grant a waiver in the third year if the ads are judged to have a positive public health benefit.
- After the 3-year period, advertising could still be stopped if studies or reports show the drug has significant harmful effects.
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]
[H.R. 1117 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1117
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
to-consumer drug advertising.
_______________________________________________________________________
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.''.
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