[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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