II
119THCONGRESS
1
STSESSION S. 652
To provide for the regulation of certain communications regarding prescription
drugs.
IN THE SENATE OF THE UNITED STATES
FEBRUARY20, 2025
Mr. D
URBIN(for himself and Mr. MARSHALL) introduced the following bill;
which was read twice and referred to the Committee on Health, Edu-
cation, 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Protecting Patients 4
from Deceptive Drug Ads Act’’. 5
SEC. 2. REGULATION OF CERTAIN COMMUNICATIONS RE-6
GARDING PRESCRIPTION DRUGS. 7
(a) R
EGULATION OFCOMMUNICATIONS.— 8
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(1) IN GENERAL.—Section 303 of the Federal 1
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 2
amended by adding at the end the following: 3
‘‘(h)(1) In the case of a social media influencer or 4
health care provider who makes false or misleading com-5
munications regarding a drug approved under section 505 6
or licensed under section 351 of the Public Health Service 7
Act, and subject to section 503(b), or compounded in ac-8
cordance with section 503A or 503B, 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 communica-14
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 re-19
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 re-24
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garding a drug described in subparagraph 1
(1); or 2
‘‘(II) fail to include information in 3
brief summary relating to side effects, con-4
traindications, and effectiveness of the 5
drug in the same manner and to the same 6
extent as such information is required in 7
prescription drug advertisements pursuant 8
to section 502(n); and 9
‘‘(ii) does not include— 10
‘‘(I) statements that take place in the 11
course of bona fide patient care or medical 12
research that are made by professionals 13
engaged in such patient care or medical re-14
search; or 15
‘‘(II) statements that describe the per-16
son’s own experience, opinion, or value 17
judgment; and 18
‘‘(B) the term ‘social media influencer’ means a 19
private individual who has perceived credibility or 20
popularity and who expresses their opinions, beliefs, 21
findings, recommendations, or experience on social 22
media platforms to an audience, including in a man-23
ner conveying trust or expertise on a topic, for the 24
purpose to promoting or advertising certain informa-25
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tion or products or inducing behavior by the audi-1
ence.’’. 2
(2) G
UIDANCE.—Not later than 180 days after 3
the date of enactment of this Act, the Secretary of 4
Health and Human Services (referred to in this sec-5
tion as the ‘‘Secretary’’) shall issue guidance on how 6
the Secretary will administer paragraph (h) of sec-7
tion 303 of the Federal Food, Drug, and Cosmetic 8
Act (21 U.S.C. 333), as added by paragraph (1), in-9
cluding with respect to the factors that will be con-10
sidered in determining whether a communication is 11
false or misleading communication, as defined in 12
such paragraph (h), including— 13
(A) the various types of statements or 14
omission of facts regarding a prescription drug 15
that would constitute false or misleading, such 16
as statements or omissions related to safety, ef-17
ficacy, approved or unapproved uses, directions 18
for use from the label approved by the Food 19
and Drug Administration, scientific informa-20
tion, or other similar attributes; 21
(B) whether the inclusion of the informa-22
tion in brief summary described in paragraph 23
(h)(2)(A)(i)(III) of section 303 of the Federal 24
Food, Drug, and Cosmetic Act (21 U.S.C. 25
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333), as added by paragraph (1), alone is suffi-1
cient in each circumstance to avoid such a de-2
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 so-8
cial media platforms, and the speed of dissemi-9
nation of the content on such platform. 10
(3) A
DDITIONAL REQUIREMENTS FOR TELE -11
HEALTH PROVIDERS.— 12
(A) I
N 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 para-16
graph, ‘manufacturer, packer, or distributor’ in-17
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) or compounded in 21
accordance with section 503A or 503B, and 22
who directly or indirectly offers to bring to-23
gether a potential patient and a prescriber or 24
dispenser through use of electronic information 25
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and telecommunication technologies to engage 1
in prescribing or dispensing of any drug subject 2
to section 503(b)(1). Nothing in this paragraph 3
shall apply to a private communication between 4
a practitioner licensed by law to prescribe or 5
dispense a prescription drug (or an individual 6
under the direct supervision of such a practi-7
tioner) and an individual patient or their rep-8
resentative.’’. 9
(B) R
EGULATIONS.—Not later than 1 year 10
after the date of enactment of this Act, the Sec-11
retary shall update the regulations promulgated 12
to carry out section 502(n) of the Federal 13
Food, Drug, and Cosmetic Act (21 U.S.C. 14
352(n)) in accordance with the amendments 15
made by subparagraph (A). 16
(4) R
ULE OF CONSTRUCTION .—Nothing in this 17
subsection, including the amendments made by this 18
subsection, precludes a drug manufacturer from tak-19
ing any corrective action to mitigate the potential 20
for patient harm from false or misleading commu-21
nications described in paragraph (h)(2)(A) of section 22
303 of the Federal Food, Drug, and Cosmetic Act 23
(21 U.S.C. 353), as added by paragraph (1). 24
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(5) EFFECTIVE DATE.—The amendments made 1
by paragraphs (1) and (3) shall take effect 180 days 2
after the date on which the regulations described in 3
paragraph (3)(B) are finalized. 4
(b) R
EPORTINGREQUIREMENT.— 5
(1) I
N GENERAL.—Any payment described in 6
paragraph (2) with respect to the promotion of, or 7
communications regarding, a covered drug shall be 8
treated as a payment from an applicable manufac-9
turer to a covered recipient for purposes of section 10
1128G of the Social Security Act (42 U.S.C. 1320a– 11
7h), and shall be reported to the Secretary of Health 12
and Human Services by the drug manufacturer or 13
health care provider making the payment and made 14
publicly available by the Secretary in accordance 15
with such section 1128G. 16
(2) P
AYMENTS DESCRIBED .—A payment de-17
scribed in this paragraph is— 18
(A) a payment by a drug manufacturer to 19
a health care provider, including a telehealth 20
company or other similar entity, or social media 21
influencer; or 22
(B) a payment by a health care provider, 23
including a telehealth provider or other similar 24
entity, to a social media influencer. 25
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(3) DEFINITIONS.—In this subsection— 1
(A) the terms ‘‘applicable manufacturer’’ 2
and ‘‘covered recipient’’ have the meanings 3
given such terms in section 1128G(e) of the So-4
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 Secu-10
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) M
ARKETSURVEILLANCE OF PRESCRIPTION 15
D
RUGADVERTISING ORPROMOTION.— 16
(1) I
N GENERAL.—The Secretary may conduct 17
market surveillance activities regarding any pro-18
motion of prescription drugs on social media plat-19
forms. The activities under this section may in-20
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
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use of artificial intelligence applications), 1
including to establish any relationship be-2
tween a manufacturer of a prescription 3
drug and individuals engaging in commu-4
nications about such drug; 5
(ii) analytical tools to review submis-6
sions of promotional communications; 7
(iii) engagement with representatives 8
of social media platforms on strategies and 9
opportunities to address false or mis-10
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 pub-15
lic facing communications and educational 16
materials and programs for prescription 17
drug manufacturers, social media plat-18
forms, and the public, which may include 19
communications and educational materials 20
and programs regarding the Bad Ad pro-21
gram of the Food and Drug Administra-22
tion; 23
(B) hiring additional staff for the Office of 24
Prescription Drug Promotion of the Center for 25
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Drug Evaluation and Research and the Adver-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 Fed-10
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) R
ULE OF CONSTRUCTION .—Nothing in 15
paragraph (1) shall be construed to affect the au-16
thority of the Secretary to carry out activities de-17
scribed in such paragraph pursuant to other provi-18
sions of law. 19
(3) FDA
NOTICE TO MANUFACTURERS .—The 20
Secretary may establish a process for providing in-21
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
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communications by health care providers or social 1
media influencers that fail to include information in 2
brief summary relating to side effects, contraindica-3
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 pur-6
suant to section 502(n) of the Federal Food, Drug, 7
and Cosmetic Act (21 U.S.C. 352(n)). 8
(4) R
EPORTING.—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 ac-16
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) A
UTHORIZATION OF APPROPRIATIONS .—To 24
carry out this subsection, there are authorized to be 25
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appropriated $15,000,000 for each of fiscal years 1
2025 through 2029. 2
(d) S
OCIALMEDIAINFLUENCER.—In this section, 3
the term ‘‘social media influencer’’ has the meaning given 4
such term in paragraph (h) of section 303 of the Federal 5
Food, Drug, and Cosmetic Act (21 U.S.C. 333), as added 6
by subsection (a). 7
(e) S
EVERABILITY.—If any provision of this Act or 8
of any amendment made by this Act, or the application 9
of such provision or amendment to any person or cir-10
cumstance, is held to be invalid, the remainder of the pro-11
visions of this Act and of the amendments made by this 12
Act and the remainder of the provisions of the Federal 13
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 14
and the application of any such provision or amendment 15
to other persons not similarly situated or to other cir-16
cumstances, shall not be affected. 17
Æ
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