119-hr1117

[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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