HR1117-119

1. Short title This Act may be cited as the Responsibility in Drug Advertising Act of 2025.

2. Direct-to-consumer drug advertising The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— in section 301 (21 U.S.C. 331), by adding at the end the following: The conduct of direct-to-consumer advertising of a drug in violation of section 506M. in chapter V, by inserting after section 506L (21 U.S.C. 356l) the following: 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. 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— the sponsor of the drug submits an application to the Secretary pursuant to subparagraph (C); and 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. 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. 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. 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. 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. 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. (jjj)The conduct of direct-to-consumer advertising of a drug in violation of section 506M.; and 506M.Direct-to-consumer drug advertising(a)Prohibitions(1)First 3 years(A)In generalSubject 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)WaiverThe 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 waiverTo 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 yearsThe 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)RegulationsNot 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 constructionThis 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 dateThis 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..

506M. Direct-to-consumer drug advertising 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. 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— the sponsor of the drug submits an application to the Secretary pursuant to subparagraph (C); and 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. 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. 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. 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. 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. 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.