PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Feb 7, 2025
Responsibility in Drug Advertising Act of 2025
This bill prohibits direct-to-consumer advertising of new drugs during the first three years following their approval by the Food and Drug Administration (FDA). Direct-to-consumer advertising includes advertising via social media.
Upon request from a drug’s sponsor, the FDA may waive the prohibition during the third year following a drug’s approval if it determines that the direct-to-consumer advertising of the drug would have an affirmative value to public health. Conversely, the FDA may prohibit such advertising beyond the three-year period following approval if it determines that the drug has significant adverse health effects based on post-approval studies, adverse event reports, and other appropriate resources.
The prohibition applies to new drugs approved beginning one year before the bill’s enactment.
People & committees
Rep. DeLauro, Rosa L. [D-CT-3] · D–CT
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
Source last updated: Jan 21, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-07 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
The proposed Responsibility in Drug Advertising Act of 2025 would generally ban advertising covered drugs directly to the public, including through social media, for three years after approval. Drug sponsors could seek permission for third-year advertising if it would have affirmative public-health value. After three years, the Secretary could prohibit advertising upon determining that a drug has significant adverse health effects. The bill's new restrictions concern advertising; they do not themselves prohibit drug sales.
This Act may be cited as the Responsibility in Drug Advertising Act of 2025.
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
determines that direct-to-consumer advertising of the drug would have an affirmative value to public health.
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
The proposed advertising rules would cover only drugs approved under section 505(c) on or after the date one year before enactment. For covered drugs, the initial three-year restriction would run from the approval date, rather than from enactment.
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.
before the end of the 3-year period beginning on the date of such approval.
The Secretary could waive the initial advertising restriction for a drug during the third year. A drug sponsor would have to apply, and the Secretary would have to determine, after considering the application and any accompanying materials, that advertising the drug directly to the public would have affirmative public-health value. Granting the exception would be discretionary.
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.
Sponsors seeking a third-year exception would have to follow the application timing, manner, and information requirements set by the Secretary.
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.
After the initial three years, the Secretary could prohibit advertising directly to the public, including on social media, upon finding significant adverse health effects. That finding could rely on studies after approval, comparisons of risks and benefits, adverse event reports, scientific literature, clinical or observational studies, or another appropriate source.
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.
The bill would add a new paragraph (jjj) to section 301 of the Federal Food, Drug, and Cosmetic Act addressing direct-to-consumer drug advertising that violates new section 506M. The supplied text does not reproduce section 301's existing language or specify penalties for that violation.
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.
Within one year after enactment, the Secretary would have to revise existing drug-advertising regulations as necessary to implement the new section.
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.
The proposal would preserve the Secretary's authority under other provisions of law to prohibit or regulate drug advertising directly to the public, including on social media.
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.
The supplied official-actions snapshot, updated January 21, 2026, records introduction in the House and referral to the House Committee on Energy and Commerce on February 7, 2025.
Source snapshot updated 2026-01-21T03:43:39Z. 2025-02-07: Referred to the House Committee on Energy and Commerce. 2025-02-07: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-07. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified after reviewing the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified after reviewing the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials; the source set cannot establish formal earmark status beyond the text.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow carve-out, special exemption, or preferential treatment warranting a targeted-benefit finding was identified after reviewing the complete supplied introduced text. Generally available waiver procedures and case-by-case administration alone do not establish preferential treatment. This conclusion is limited to the supplied introduced version and does not establish absence in other versions or accompanying materials.
Full text preserved for this analysis. Legislative record snapshot: Jan 21, 2026. How PlainBill uses AI