| 1 | 1 | | II |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 483 |
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| 5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- |
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| 6 | 6 | | to-consumer drug advertising. |
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| 7 | 7 | | IN THE SENATE OF THE UNITED STATES |
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| 8 | 8 | | FEBRUARY6 (legislative day, FEBRUARY5), 2025 |
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| 9 | 9 | | Mr. K |
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| 10 | 10 | | ING(for himself, Mr. KAINE, and Mr. WELCH) introduced the following |
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| 11 | 11 | | bill; which was read twice and referred to the Committee on Health, Edu- |
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| 12 | 12 | | cation, Labor, and Pensions |
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| 13 | 13 | | A BILL |
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| 14 | 14 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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| 15 | 15 | | restrict direct-to-consumer drug advertising. |
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| 16 | 16 | | Be it enacted by the Senate and House of Representa-1 |
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| 17 | 17 | | tives of the United States of America in Congress assembled, 2 |
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| 18 | 18 | | SECTION 1. SHORT TITLE. 3 |
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| 19 | 19 | | This Act may be cited as the ‘‘Responsibility in Drug 4 |
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| 20 | 20 | | Advertising Act of 2025’’. 5 |
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| 21 | 21 | | SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 6 |
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| 22 | 22 | | The Federal Food, Drug, and Cosmetic Act (21 7 |
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| 23 | 23 | | U.S.C. 301 et seq.) is amended— 8 |
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| 24 | 24 | | (1) in section 301 (21 U.S.C. 331), by adding 9 |
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| 25 | 25 | | at the end the following: 10 |
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| 26 | 26 | | VerDate Sep 11 2014 04:50 Mar 07, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S483.IS S483 |
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| 27 | 27 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 28 | 28 | | •S 483 IS |
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| 29 | 29 | | ‘‘(jjj) The conduct of direct-to-consumer advertising 1 |
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| 30 | 30 | | of a drug in violation of section 506M.’’; and 2 |
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| 31 | 31 | | (2) in chapter V, by inserting after section 3 |
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| 32 | 32 | | 506L (21 U.S.C. 356l) the following: 4 |
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| 33 | 33 | | ‘‘SEC. 506M. DIRECT-TO-CONSUMER DRUG ADVERTISING. 5 |
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| 34 | 34 | | ‘‘(a) P |
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| 35 | 35 | | ROHIBITIONS.— 6 |
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| 36 | 36 | | ‘‘(1) F |
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| 37 | 37 | | IRST 3 YEARS.— 7 |
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| 38 | 38 | | ‘‘(A) I |
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| 39 | 39 | | N GENERAL.—Subject to subpara-8 |
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| 40 | 40 | | graph (B), no person shall conduct direct-to- 9 |
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| 41 | 41 | | consumer advertising, including on a social 10 |
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| 42 | 42 | | media platform, of a drug approved under sec-11 |
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| 43 | 43 | | tion 505(c) before the end of the 3-year period 12 |
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| 44 | 44 | | beginning on the date of such approval. 13 |
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| 45 | 45 | | ‘‘(B) W |
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| 46 | 46 | | AIVER.—The Secretary may waive 14 |
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| 47 | 47 | | the application of subparagraph (A) to a drug 15 |
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| 48 | 48 | | during the third year of the 3-year period de-16 |
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| 49 | 49 | | scribed in such subparagraph if— 17 |
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| 50 | 50 | | ‘‘(i) the sponsor of the drug submits 18 |
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| 51 | 51 | | an application to the Secretary pursuant to 19 |
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| 52 | 52 | | subparagraph (C); and 20 |
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| 53 | 53 | | ‘‘(ii) the Secretary, after considering 21 |
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| 54 | 54 | | the application and any accompanying ma-22 |
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| 55 | 55 | | terials, determines that direct-to-consumer 23 |
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| 56 | 56 | | advertising of the drug would have an af-24 |
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| 57 | 57 | | firmative value to public health. 25 |
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| 58 | 58 | | VerDate Sep 11 2014 04:50 Mar 07, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S483.IS S483 |
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| 59 | 59 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
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| 60 | 60 | | •S 483 IS |
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| 61 | 61 | | ‘‘(C) APPLICATION FOR WAIVER .—To seek 1 |
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| 62 | 62 | | a waiver under subparagraph (B), the sponsor 2 |
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| 63 | 63 | | of a drug shall submit an application to the 3 |
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| 64 | 64 | | Secretary at such time, in such manner, and 4 |
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| 65 | 65 | | containing such information as the Secretary 5 |
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| 66 | 66 | | may require. 6 |
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| 67 | 67 | | ‘‘(2) S |
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| 68 | 68 | | UBSEQUENT YEARS .—The Secretary may 7 |
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| 69 | 69 | | prohibit direct-to-consumer advertising, including on 8 |
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| 70 | 70 | | social media platforms, of a drug during the period 9 |
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| 71 | 71 | | beginning at the end of the 3-year period described 10 |
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| 72 | 72 | | in paragraph (1)(A) if the Secretary determines that 11 |
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| 73 | 73 | | the drug has significant adverse health effects based 12 |
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| 74 | 74 | | on post-approval studies, risk-benefit analyses, ad-13 |
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| 75 | 75 | | verse event reports, the scientific literature, any clin-14 |
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| 76 | 76 | | ical or observational studies, or any other appro-15 |
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| 77 | 77 | | priate resource. 16 |
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| 78 | 78 | | ‘‘(b) R |
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| 79 | 79 | | EGULATIONS.—Not later than 1 year after the 17 |
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| 80 | 80 | | date of the enactment of this section, the Secretary shall 18 |
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| 81 | 81 | | revise the regulations promulgated under this Act gov-19 |
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| 82 | 82 | | erning drug advertisements to the extent necessary to im-20 |
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| 83 | 83 | | plement this section. 21 |
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| 84 | 84 | | ‘‘(c) R |
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| 85 | 85 | | ULE OFCONSTRUCTION.—This section shall 22 |
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| 86 | 86 | | not be construed to diminish the authority of the Secretary 23 |
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| 87 | 87 | | to prohibit or regulate direct-to-consumer advertising of 24 |
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| 88 | 88 | | VerDate Sep 11 2014 04:50 Mar 07, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S483.IS S483 |
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| 89 | 89 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
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| 90 | 90 | | •S 483 IS |
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| 91 | 91 | | drugs, including on social media platforms, under any 1 |
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| 92 | 92 | | other provision of law. 2 |
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| 93 | 93 | | ‘‘(d) E |
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| 94 | 94 | | FFECTIVEDATE.—This section applies only 3 |
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| 95 | 95 | | with respect to a drug approved under section 505(c) on 4 |
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| 96 | 96 | | or after the date that is 1 year before the date of enact-5 |
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| 97 | 97 | | ment of this section.’’. 6 |
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| 98 | 98 | | Æ |
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| 99 | 99 | | VerDate Sep 11 2014 04:50 Mar 07, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S483.IS S483 |
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| 100 | 100 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
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