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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4785 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4785

 To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
                     to-consumer drug advertising.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 25, 2024

    Mr. King (for himself, Mr. Welch, and Mr. Kaine) 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 2024''.

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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