[Congressional Record Volume 171, Number 34 (Thursday, February 20, 2025)]
[Senate]
[Pages S1129-S1130]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN (for himself and Mr. Marshall):
S. 652. A bill to provide for the regulation of certain
communications regarding prescription drugs; to the Committee on
Health, Education, Labor, and Pensions.
Mr. DURBIN. Mr. 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. 652
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 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), or compounded in accordance with section 503A
or 503B, 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
[[Page S1130]]
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) or compounded in accordance with
section 503A or 503B, 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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