II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Patients 

5 from Deceptive Drug Ads Online Act’’. 

6 SEC. 2. REGULATION OF CERTAIN COMMUNICATIONS RE7 GARDING PRESCRIPTION DRUGS. 

8 (a) REGULATION OF COMMUNICATIONS.— 


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1 (1) IN GENERAL.—Section 303 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 

3 amended by adding at the end the following: 

4 ‘‘(h)(1) In the case of a social media influencer or 

5 health care provider who makes false or misleading com6 munications regarding a drug approved under section 505 

7 or licensed under section 351 of the Public Health Service 

8 Act, and subject to section 503(b), shall be liable to the 

9 United States for a civil penalty in an amount described 

10 in paragraph (g)(1), in accordance with a process similar 

11 to the process described in paragraph (g)(2). 

12 ‘‘(2) For purposes of this paragraph— 

13 ‘‘(A) the term ‘false or misleading communica14 tions’— 

15 ‘‘(i) means advertisements or promotional 

16 communications on a social media platform 

17 from which there is a financial benefit to the 

18 person engaging in such communications re19 garding such drug— 

20 ‘‘(I)(aa) that are made knowingly or 

21 recklessly; and 

22 ‘‘(bb) contain a false or inaccurate 

23 statement or material omission of fact re24 garding a drug described in subparagraph 

25 (1); or 


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1 ‘‘(II) fail to include information in 

2 brief summary relating to side effects, con3 traindications, and effectiveness of the 

4 drug in the same manner and to the same 

5 extent as such information is required in 

6 prescription drug advertisements pursuant 

7 to section 502(n); and 

8 ‘‘(ii) does not include— 

9 ‘‘(I) statements that take place in the 

10 course of bona fide patient care or medical 

11 research that are made by professionals 

12 engaged in such patient care or medical re13 search; or 

14 ‘‘(II) statements that describe the per15 son’s own experience, opinion, or value 

16 judgment; and 

17 ‘‘(B) the term ‘social media influencer’ means a 

18 private individual who has perceived credibility or 

19 popularity and who expresses their opinions, beliefs, 

20 findings, recommendations, or experience on social 

21 media platforms to an audience, including in a man22 ner conveying trust or expertise on a topic, for the 

23 purpose to promoting or advertising certain informa24 tion or products or inducing behavior by the audi25 ence.’’. 


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1 (2) GUIDANCE.—Not later than 180 days after 

2 the date of enactment of this Act, the Secretary of 

3 Health and Human Services (referred to in this sec4 tion as the ‘‘Secretary’’) shall issue guidance on how 

5 the Secretary will administer paragraph (h) of sec6 tion 303 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 333), as added by paragraph (1), in8 cluding with respect to the factors that will be con9 sidered in determining whether a communication is 

10 false or misleading communication, as defined in 

11 such paragraph (h), including— 

12 (A) the various types of statements or 

13 omission of facts regarding a prescription drug 

14 that would constitute false or misleading, such 

15 as statements or omissions related to safety, ef16 ficacy, approved or unapproved uses, directions 

17 for use from the label approved by the Food 

18 and Drug Administration, scientific informa19 tion, or other similar attributes; 

20 (B) whether the inclusion of the informa21 tion in brief summary described in paragraph 

22 (h)(2)(A)(i)(III) of section 303 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 333), as added by paragraph (1), alone is suffiVerDate Sep 11 2014 22:28 Sep 18, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S5040.IS S5040

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1 cient in each circumstance to avoid such a de2 termination; 

3 (C) actions taken by the social media 

4 influencer, health care provider, or other person 

5 to demonstrate compliance with such paragraph 

6 (h); and 

7 (D) characteristics specific to various so8 cial media platforms, and the speed of dissemi9 nation of the content on such platform. 

10 (3) ADDITIONAL REQUIREMENTS FOR TELE11 HEALTH PROVIDERS.— 

12 (A) IN GENERAL.—Section 502(n) of the 

13 Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 352(n)) is amended by adding at the 

15 end the following: ‘‘For purposes of this para16 graph, ‘manufacturer, packer, or distributor’ in17 cludes a person who issues or causes to be 

18 issued an advertisement or other descriptive 

19 printed matter with respect to a specific drug 

20 subject to section 503(b)(1) and who directly or 

21 indirectly offers to bring together a potential 

22 patient and a prescriber or dispenser through 

23 use of electronic information and telecommuni24 cation technologies to engage in prescribing or 

25 dispensing of any drug subject to section 


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1 503(b)(1). Nothing in this paragraph shall 

2 apply to a private communication between a 

3 practitioner licensed by law to prescribe or dis4 pense a prescription drug (or an individual 

5 under the direct supervision of such a practi6 tioner) and an individual patient or their rep7 resentative.’’. 

8 (B) REGULATIONS.—Not later than 1 year 

9 after the date of enactment of this Act, the Sec10 retary shall update the regulations promulgated 

11 to carry out section 502(n) of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 

13 352(n)) in accordance with the amendments 

14 made by subparagraph (A). 

15 (4) RULE OF CONSTRUCTION.—Nothing in this 

16 subsection, including the amendments made by this 

17 subsection, precludes a drug manufacturer from tak18 ing any corrective action to mitigate the potential 

19 for patient harm from false or misleading commu20 nications described in paragraph (h)(2)(A) of section 

21 303 of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 353), as added by paragraph (1). 

23 (5) EFFECTIVE DATE.—The amendments made 

24 by paragraphs (1) and (3) shall take effect 180 days 


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1 after the date on which the regulations described in 

2 paragraph (3)(B) are finalized. 

3 (b) REPORTING REQUIREMENT.— 

4 (1) IN GENERAL.—Any payment described in 

5 paragraph (2) with respect to the promotion of, or 

6 communications regarding, a covered drug shall be 

7 treated as a payment from an applicable manufac8 turer to a covered recipient for purposes of section 

9 1128G of the Social Security Act (42 U.S.C. 1320a– 

10 7h), and shall be reported to the Secretary of Health 

11 and Human Services by the drug manufacturer or 

12 health care provider making the payment and made 

13 publicly available by the Secretary in accordance 

14 with such section 1128G. 

15 (2) PAYMENTS DESCRIBED.—A payment de16 scribed in this paragraph is— 

17 (A) a payment by a drug manufacturer to 

18 a health care provider, including a telehealth 

19 company or other similar entity, or social media 

20 influencer; or 

21 (B) a payment by a health care provider, 

22 including a telehealth provider or other similar 

23 entity, to a social media influencer. 

24 (3) DEFINITIONS.—In this subsection— 


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1 (A) the terms ‘‘applicable manufacturer’’ 

2 and ‘‘covered recipient’’ have the meanings 

3 given such terms in section 1128G(e) of the So4 cial Security Act (42 U.S.C. 1320a–7h); and 

5 (B) the term ‘‘covered drug’’ means any 

6 drug, including a biological product (as defined 

7 in section 351(i) of the Public Health Service 

8 Act (42 U.S.C. 262(i))), for which payment is 

9 available under title XVIII of the Social Secu10 rity Act (42 U.S.C. 1395 et seq.) or a State 

11 plan under title XIX or XXI of such Act (42 

12 U.S.C. 1396 et seq.; 42 U.S.C. 1397aa et seq.) 

13 (or a waiver of such a plan). 

14 (c) MARKET SURVEILLANCE OF PRESCRIPTION

15 DRUG ADVERTISING OR PROMOTION.— 

16 (1) IN GENERAL.—The Secretary may conduct 

17 market surveillance activities regarding any pro18 motion of prescription drugs on social media plat19 forms. The activities under this section may in20 clude— 

21 (A) activities, carried out directly or by 

22 contract, relating to— 

23 (i) aggregating and analysis of public 

24 communications (which may involve the 

25 use of artificial intelligence applications), 


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1 including to establish any relationship be2 tween a manufacturer of a prescription 

3 drug and individuals engaging in commu4 nications about such drug; 

5 (ii) analytical tools to review submis6 sions of promotional communications; 

7 (iii) engagement with representatives 

8 of social media platforms on strategies and 

9 opportunities to address false or mis10 leading promotion of prescription drugs, 

11 including through methods of technology 

12 or functionality to identify and assess false 

13 or misleading communications; and 

14 (iv) developing and disseminating pub15 lic facing communications and educational 

16 materials and programs for prescription 

17 drug manufacturers, social media plat18 forms, and the public, which may include 

19 communications and educational materials 

20 and programs regarding the Bad Ad pro21 gram of the Food and Drug Administra22 tion; 

23 (B) hiring additional staff for the Office of 

24 Prescription Drug Promotion of the Center for 

25 Drug Evaluation and Research and the AdverVerDate Sep 11 2014 22:28 Sep 18, 2024 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S5040.IS S5040

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1 tising and Promotional Labeling Branch of the 

2 Center for Biologics Evaluation and Research 

3 for the review of advertising or promotion of 

4 prescription drugs on digital platforms, such as 

5 social media, and such other purposes as the 

6 Secretary determines appropriate; and 

7 (C) establishing a task force, jointly with 

8 the Federal Trade Commission, to coordinate 

9 and enhance communication between the Fed10 eral Trade Commission and the Food and Drug 

11 Administration related to monitoring of, and 

12 compliance activities relating to, prescription 

13 drug advertising or promotion. 

14 (2) RULE OF CONSTRUCTION.—Nothing in 

15 paragraph (1) shall be construed to affect the au16 thority of the Secretary to carry out activities de17 scribed in such paragraph pursuant to other provi18 sions of law. 

19 (3) FDA NOTICE TO MANUFACTURERS.—The 

20 Secretary may establish a process for providing in21 formation to the holder of an approved application 

22 of a prescription drug under section 505 of this Act 

23 or section 351 of the Public Health Service Act for 

24 the purpose of notifying such holder of instances of 

25 communications by health care providers or social 


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1 media influencers that fail to include information in 

2 brief summary relating to side effects, contraindica3 tions, and effectiveness of the drug in the same 

4 manner and to the same extent as such information 

5 is required in prescription drug advertisements pur6 suant to section 502(n) of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 352(n)). 

8 (4) REPORTING.—The Secretary shall— 

9 (A) not later than 2 years after the date 

10 of enactment of this Act, submit to Congress a 

11 report on the activities carried out under this 

12 subsection; 

13 (B) not later than 4 years after the date 

14 of enactment of this Act, submit to Congress, 

15 and make publicly available, a report on the ac16 tivities carried out under this subsection; and 

17 (C) make publicly available on the website 

18 of the Food and Drug Administration notice of 

19 all enforcement actions taken under paragraph 

20 (h) of section 303 of the Federal Food, Drug, 

21 and Cosmetic Act (21 U.S.C. 333), as added by 

22 subsection (a). 

23 (5) AUTHORIZATION OF APPROPRIATIONS.—To 

24 carry out this subsection, there are authorized to be 


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1 appropriated $15,000,000 for each of fiscal years 

2 2025 through 2029. 

3 (d) SOCIAL MEDIA INFLUENCER.—In this section, 

4 the term ‘‘social media influencer’’ has the meaning given 

5 such term in paragraph (h) of section 303 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 333), as added 

7 by subsection (a). 

8 (e) SEVERABILITY.—If any provision of this Act or 

9 of any amendment made by this Act, or the application 

10 of such provision or amendment to any person or cir11 cumstance, is held to be invalid, the remainder of the pro12 visions of this Act and of the amendments made by this 

13 Act and the remainder of the provisions of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 

15 and the application of any such provision or amendment 

16 to other persons not similarly situated or to other cir17 cumstances, shall not be affected. 

Æ 


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