II 

118TH CONGRESS 

2D SESSION S. 4785 

To amend the Federal Food, Drug, and Cosmetic Act to restrict directto-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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Responsibility in Drug 

5 Advertising Act of 2024’’. 

6 SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 

7 The Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 301 et seq.) is amended— 

9 (1) in section 301 (21 U.S.C. 331), by adding 

10 at the end the following: 


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1 ‘‘(jjj) The conduct of direct-to-consumer advertising 

2 of a drug in violation of section 506M.’’; and 

3 (2) in chapter V, by inserting after section 

4 506L (21 U.S.C. 356l) the following: 

5 ‘‘SEC. 506M. DIRECT-TO-CONSUMER DRUG ADVERTISING. 

6 ‘‘(a) PROHIBITIONS.— 

7 ‘‘(1) FIRST 3 YEARS.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (B), no person shall conduct direct-to10 consumer advertising, including on a social 

11 media platform, of a drug approved under sec12 tion 505(c) before the end of the 3-year period 

13 beginning on the date of such approval. 

14 ‘‘(B) WAIVER.—The Secretary may waive 

15 the application of subparagraph (A) to a drug 

16 during the third year of the 3-year period de17 scribed in such subparagraph if— 

18 ‘‘(i) the sponsor of the drug submits 

19 an application to the Secretary pursuant to 

20 subparagraph (C); and 

21 ‘‘(ii) the Secretary, after considering 

22 the application and any accompanying ma23 terials, determines that direct-to-consumer 

24 advertising of the drug would have an af25 firmative value to public health. 


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1 ‘‘(C) APPLICATION FOR WAIVER.—To seek 

2 a waiver under subparagraph (B), the sponsor 

3 of a drug shall submit an application to the 

4 Secretary at such time, in such manner, and 

5 containing such information as the Secretary 

6 may require. 

7 ‘‘(2) SUBSEQUENT YEARS.—The Secretary may 

8 prohibit direct-to-consumer advertising, including on 

9 social media platforms, of a drug during the period 

10 beginning at the end of the 3-year period described 

11 in paragraph (1)(A) if the Secretary determines that 

12 the drug has significant adverse health effects based 

13 on post-approval studies, risk-benefit analyses, ad14 verse event reports, the scientific literature, any clin15 ical or observational studies, or any other appro16 priate resource. 

17 ‘‘(b) REGULATIONS.—Not later than 1 year after the 

18 date of the enactment of this section, the Secretary shall 

19 revise the regulations promulgated under this Act gov20 erning drug advertisements to the extent necessary to im21 plement this section. 

22 ‘‘(c) RULE OF CONSTRUCTION.—This section shall 

23 not be construed to diminish the authority of the Secretary 

24 to prohibit or regulate direct-to-consumer advertising of 


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1 drugs, including on social media platforms, under any 

2 other provision of law. 

3 ‘‘(d) EFFECTIVE DATE.—This section applies only 

4 with respect to a drug approved under section 505(c) on 

5 or after the date that is 1 year before the date of enact6 ment of this section.’’. 

Æ 


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