[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5040 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  2d Session
                                S. 5040

   To provide for the regulation of certain communications regarding 
                          prescription drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 12, 2024

 Mr. Durbin (for himself and Mr. Braun) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To provide for the regulation of certain communications regarding 
                          prescription drugs.

    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 
                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; and
                            (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.
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