[Congressional Record Volume 170, Number 142 (Thursday, September 12, 2024)]
[Senate]
[Pages S6021-S6022]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Braun):
  S. 5040. A bill to provide for the regulation of certain 
communications regarding prescription drugs; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. DURBIN. Madam President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 5040

       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 ``Protecting Patients from 
     Deceptive Drug Ads Online Act''.

     SEC. 2. REGULATION OF CERTAIN COMMUNICATIONS REGARDING 
                   PRESCRIPTION DRUGS.

       (a) Regulation of Communications.--
       (1) In general.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(h)(1) In the case of a social media influencer or health 
     care provider who makes false or misleading communications 
     regarding a drug approved under section 505 or licensed under 
     section 351 of the Public Health Service Act, and subject to 
     section 503(b), shall be liable to the United States for a 
     civil penalty in an amount described in paragraph (g)(1), in 
     accordance with a process similar to the process described in 
     paragraph (g)(2).
       ``(2) For purposes of this paragraph--
       ``(A) the term `false or misleading communications'--
       ``(i) means advertisements or promotional communications on 
     a social media platform from which there is a financial 
     benefit to the person engaging in such communications 
     regarding such drug--
       ``(I)(aa) that are made knowingly or recklessly; and
       ``(bb) contain a false or inaccurate statement or material 
     omission of fact regarding a drug described in subparagraph 
     (1); or
       ``(II) fail to include information in brief summary 
     relating to side effects, contraindications, and 
     effectiveness of the drug in the same manner and to the same 
     extent as such information is required in prescription drug 
     advertisements pursuant to section 502(n); and
       ``(ii) does not include--
       ``(I) statements that take place in the course of bona fide 
     patient care or medical research that are made by 
     professionals engaged in such patient care or medical 
     research; or
       ``(II) statements that describe the person's own 
     experience, opinion, or value judgment; and
       ``(B) the term `social media influencer' means a private 
     individual who has perceived credibility or popularity and 
     who expresses their opinions, beliefs, findings, 
     recommendations, or experience on social media platforms to 
     an audience, including in a manner conveying trust or 
     expertise on a topic, for the purpose to promoting or 
     advertising certain information or products or inducing 
     behavior by the audience.''.
       (2) Guidance.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue guidance on how the Secretary will administer 
     paragraph (h) of section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333), as added by paragraph (1), 
     including with respect to the factors that will be considered 
     in determining whether a communication is false or misleading 
     communication, as defined in such paragraph (h), including--
       (A) the various types of statements or omission of facts 
     regarding a prescription drug that would constitute false or 
     misleading, such as statements or omissions related to 
     safety, efficacy, approved or unapproved uses, directions for 
     use from the label approved by the Food and Drug 
     Administration, scientific information, or other similar 
     attributes;
       (B) whether the inclusion of the information in brief 
     summary described in paragraph (h)(2)(A)(i)(III) of section 
     303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     333), as added by paragraph (1), alone is sufficient in each 
     circumstance to avoid such a determination;
       (C) actions taken by the social media influencer, health 
     care provider, or other person to demonstrate compliance with 
     such paragraph (h); and
       (D) characteristics specific to various social media 
     platforms, and the speed of dissemination of the content on 
     such platform.
       (3) Additional requirements for telehealth providers.--
       (A) In general.--Section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding at 
     the end the following: ``For purposes of this paragraph, 
     `manufacturer, packer, or distributor' includes a person who 
     issues or causes to be issued an advertisement or other 
     descriptive printed matter with respect to a specific drug 
     subject to section 503(b)(1) and who directly or indirectly 
     offers to bring together a potential patient and a prescriber 
     or dispenser through use of electronic information and 
     telecommunication technologies to engage in prescribing or 
     dispensing of any drug subject to section 503(b)(1). Nothing 
     in this paragraph shall apply to a private communication 
     between a practitioner licensed by law to prescribe or 
     dispense a prescription drug (or an individual under the 
     direct supervision of such a practitioner) and an individual 
     patient or their representative.''.
       (B) Regulations.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall update the 
     regulations promulgated to carry out section 502(n) of the 
     Federal Food, Drug, and Cosmetic Act (21

[[Page S6022]]

     U.S.C. 352(n)) in accordance with the amendments made by 
     subparagraph (A).
       (4) Rule of construction.--Nothing in this subsection, 
     including the amendments made by this subsection, precludes a 
     drug manufacturer from taking any corrective action to 
     mitigate the potential for patient harm from false or 
     misleading communications described in paragraph (h)(2)(A) of 
     section 303 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 353), as added by paragraph (1).
       (5) Effective date.--The amendments made by paragraphs (1) 
     and (3) shall take effect 180 days after the date on which 
     the regulations described in paragraph (3)(B) are finalized.
       (b) Reporting Requirement.--
       (1) In general.--Any payment described in paragraph (2) 
     with respect to the promotion of, or communications 
     regarding, a covered drug shall be treated as a payment from 
     an applicable manufacturer to a covered recipient for 
     purposes of section 1128G of the Social Security Act (42 
     U.S.C. 1320a-7h), and shall be reported to the Secretary of 
     Health and Human Services by the drug manufacturer or health 
     care provider making the payment and made publicly available 
     by the Secretary in accordance with such section 1128G.
       (2) Payments described.--A payment described in this 
     paragraph is--
       (A) a payment by a drug manufacturer to a health care 
     provider, including a telehealth company or other similar 
     entity, or social media influencer; or
       (B) a payment by a health care provider, including a 
     telehealth provider or other similar entity, to a social 
     media influencer.
       (3) Definitions.--In this subsection--
       (A) the terms ``applicable manufacturer'' and ``covered 
     recipient'' have the meanings given such terms in section 
     1128G(e) of the Social Security Act (42 U.S.C. 1320a-7h); and
       (B) the term ``covered drug'' means any drug, including a 
     biological product (as defined in section 351(i) of the 
     Public Health Service Act (42 U.S.C. 262(i))), for which 
     payment is available under title XVIII of the Social Security 
     Act (42 U.S.C. 1395 et seq.) or a State plan under title XIX 
     or XXI of such Act (42 U.S.C. 1396 et seq.; 42 U.S.C. 1397aa 
     et seq.) (or a waiver of such a plan).
       (c) Market Surveillance of Prescription Drug Advertising or 
     Promotion.--
       (1) In general.--The Secretary may conduct market 
     surveillance activities regarding any promotion of 
     prescription drugs on social media platforms. The activities 
     under this section may include--
       (A) activities, carried out directly or by contract, 
     relating to--
       (i) aggregating and analysis of public communications 
     (which may involve the use of artificial intelligence 
     applications), including to establish any relationship 
     between a manufacturer of a prescription drug and individuals 
     engaging in communications about such drug;
       (ii) analytical tools to review submissions of promotional 
     communications;
       (iii) engagement with representatives of social media 
     platforms on strategies and opportunities to address false or 
     misleading promotion of prescription drugs, including through 
     methods of technology or functionality to identify and assess 
     false or misleading communications;
       (iv) developing and disseminating public facing 
     communications and educational materials and programs for 
     prescription drug manufacturers, social media platforms, and 
     the public, which may include communications and educational 
     materials and programs regarding the Bad Ad program of the 
     Food and Drug Administration;
       (B) hiring additional staff for the Office of Prescription 
     Drug Promotion of the Center for Drug Evaluation and Research 
     and the Advertising and Promotional Labeling Branch of the 
     Center for Biologics Evaluation and Research for the review 
     of advertising or promotion of prescription drugs on digital 
     platforms, such as social media, and such other purposes as 
     the Secretary determines appropriate; and
       (C) establishing a task force, jointly with the Federal 
     Trade Commission, to coordinate and enhance communication 
     between the Federal Trade Commission and the Food and Drug 
     Administration related to monitoring of, and compliance 
     activities relating to, prescription drug advertising or 
     promotion.
       (2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed to affect the authority of the Secretary to 
     carry out activities described in such paragraph pursuant to 
     other provisions of law.
       (3) FDA notice to manufacturers.--The Secretary may 
     establish a process for providing information to the holder 
     of an approved application of a prescription drug under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act for the purpose of notifying such holder of 
     instances of communications by health care providers or 
     social media influencers that fail to include information in 
     brief summary relating to side effects, contraindications, 
     and effectiveness of the drug in the same manner and to the 
     same extent as such information is required in prescription 
     drug advertisements pursuant to section 502(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)).
       (4) Reporting.--The Secretary shall--
       (A) not later than 2 years after the date of enactment of 
     this Act, submit to Congress a report on the activities 
     carried out under this subsection;
       (B) not later than 4 years after the date of enactment of 
     this Act, submit to Congress, and make publicly available, a 
     report on the activities carried out under this subsection; 
     and
       (C) make publicly available on the website of the Food and 
     Drug Administration notice of all enforcement actions taken 
     under paragraph (h) of section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333), as added by subsection (a).
       (5) Authorization of appropriations.--To carry out this 
     subsection, there are authorized to be appropriated 
     $15,000,000 for each of fiscal years 2025 through 2029.
       (d) Social Media Influencer.--In this section, the term 
     ``social media influencer'' has the meaning given such term 
     in paragraph (h) of section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333), as added by subsection (a).
       (e) Severability.--If any provision of this Act or of any 
     amendment made by this Act, or the application of such 
     provision or amendment to any person or circumstance, is held 
     to be invalid, the remainder of the provisions of this Act 
     and of the amendments made by this Act and the remainder of 
     the provisions of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 301 et seq.), and the application of any such 
     provision or amendment to other persons not similarly 
     situated or to other circumstances, shall not be affected.

                          ____________________