[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7473 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7473
To prohibit pharmaceutical manufacturers from interfering with
therapeutically equivalent or interchangeable substitution decisions by
health care providers to limit competition from a generic drug or
biosimilar biological product, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 7, 2022
Mrs. Carolyn B. Maloney of New York (for herself, Mr. Cicilline, Mr.
Nadler, Mr. Welch, Ms. Schakowsky, Ms. Porter, Mr. DeSaulnier, and Mr.
Raskin) introduced the following bill; which was referred to the
Committee on the Judiciary
_______________________________________________________________________
A BILL
To prohibit pharmaceutical manufacturers from interfering with
therapeutically equivalent or interchangeable substitution decisions by
health care providers to limit competition from a generic drug or
biosimilar biological product, and for other purposes.
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 ``Generic Substitution Noninterference
Act''.
SEC. 2. DECLARATION OF PURPOSES.
The purposes of this Act are--
(1) to enhance competition in the pharmaceutical market by
stopping anticompetitive practices that limit or prevent
competition from generic drugs and biosimilar biological
products,
(2) to support the purposes and intent of antitrust law by
prohibiting anticompetitive practices in the pharmaceutical
industry that harm consumers, and
(3) to preserve physician autonomy.
SEC. 3. INTERFERENCE WITH PROVIDER SUBSTITUTION DECISIONS.
(a) Prohibition.--It shall be unlawful for a pharmaceutical
manufacturer--
(1) to provide any item or service, or anything of value,
for the purpose of aiding or assisting a health care provider
to request or direct that a drug be dispensed ``as written'' or
``brand name only'' when a generic drug or biosimilar
biological product is available, including any prescription
notepad or prescription stamp, but not including any product
sample, or
(2) to direct a health care provider to write ``dispense as
written'', ``brand name only'', or another similar notation or
direction on a prescription when a generic drug or biosimilar
biological product is available.
(b) Limitation.--Nothing in this section prevents a health care
provider from exercising the provider's own medical judgment to
prescribe any drug or biologic product.
(c) Civil Penalty Actions.--If the Commission has reason to believe
that a pharmaceutical manufacturer has violated or is violating this
Act, the Federal Trade Commission may commence a civil action to
recover a civil penalty and seek other appropriate relief in a district
court of the United States against the pharmaceutical manufacturer.
Except as otherwise provided in section 16(a)(2) of the Federal Trade
Commission Act (15 U.S.C. 56(a)(3)), the Commission shall have
exclusive authority to commence or defend, and supervise the litigation
of, any civil action under paragraph (1) and any appeal of such action
in its own name by any of its attorneys designated by it for such
purpose, unless the Commission authorizes the Attorney General to do
so. The Commission shall inform the Attorney General of the exercise of
such authority and such exercise shall not preclude the Attorney
General from intervening on behalf of the United States in such action
and any appeal of such action as may be otherwise provided by law. The
civil penalty shall be sufficient to deter violations of this section,
but in no event shall be greater than three times the gross revenues
received for sales of the brand-name drug during the period in which
the prohibited conduct occurred. In determining the amount of the civil
penalty, the court shall take into account--
(1) the nature, circumstances, extent, and gravity of the
violation with respect to the pharmaceutical manufacturer,
(2) the degree of culpability,
(3) the history of violations,
(4) the ability to pay, and any effect on the ability to
continue doing business, and
(5) other matters that justice requires.
(d) Unfair Method of Competition.--A violation of this Act shall
also constitute an unfair method of competition under section 5(a)(1)
of the Federal Trade Commission Act (15 U.S.C. 45(a)(1)).
(e) Enforcement Authority.--Except as otherwise provided in
subsection (c), the Commission shall enforce this Act in the same
manner, by the same means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of the Federal
Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and
made a part of this Act.
(f) Actions by States.--
(1) In general.--In any case in which the attorney general
of a State has reason to believe that an interest of the
residents of that State has been or is threatened or adversely
affected by the engagement of a pharmaceutical manufacturer in
any conduct described in subsection (a), the State, as parens
patriae, may bring a civil action on behalf of the residents of
the State in a district court of the United States of
appropriate jurisdiction to enjoin that practice, to obtain
damages, restitution, or other compensation on behalf of
residents of such State, or to obtain such further and other
relief as the court may deem appropriate.
(2) Notice.--The State shall serve prior written notice of
any civil action under this subsection upon the Commission and
provide the Commission with a copy of its complaint, except
that if it is not feasible for the State to provide such prior
notice, the State shall serve such notice immediately upon
instituting such action. Upon receiving a notice respecting a
civil action, the Commission shall have the right to--
(A) intervene in such action,
(B) upon so intervening, to be heard on all matters
arising therein, and
(C) to file petitions for appeal.
(3) Construction.--For purposes of bringing a civil action
under this subsection, nothing in this Act shall prevent an
attorney general from exercising the powers conferred on the
attorney general by the laws of such State to conduct
investigations, or to administer oaths or affirmations, or to
compel the attendance of witnesses or the production of
documentary and other evidence.
(4) Actions by commission.--Whenever a civil action has
been instituted by or on behalf of the Commission for violation
of this Act, no State may, during the pendency of such action
instituted by or on behalf of the Commission, institute a civil
action under this subsection against any defendant named in the
complaint in such action for violation of this Act.
(5) Venue; service of process.--Any civil action brought
under this subsection in a district court of the United States
may be brought in the district in which the defendant is found,
is an inhabitant, or transacts business or wherever venue is
proper under section 1391 of title 28. Process in such an
action may be served in any district in which the defendant is
an inhabitant or in which the defendant may be found.
(g) Definitions.--In this section:
(1) Antitrust laws.--The term ``antitrust laws'' has the
meaning given the term in subsection (a) of the 1st section of
the Clayton Act (15 U.S.C. 12(a)).
(2) Biosimilar biological product.--The term ``biosimilar
biological product'' means a biological product licensed under
section 351(k) of the Public Health Service Act.
(3) Brand name drug.--The term ``brand name drug'' means a
drug approved or licensed under section 505(c) of the Federal
Food, Drug, and Cosmetic Act or section 351(a) of the Public
Health Service Act.
(4) Generic drug.--The term ``generic drug'' means a drug
approved under section 505(j) of the Federal Food, Drug, and
Cosmetic Act.
(5) Health care provider.--The term ``health care
provider'' means any individual or entity, including any
pharmacy, that participates in any Federal health care program
(as defined in section 1128B(f)) of the Social Security Act.
(6) Pharmaceutical manufacturer.--The term ``pharmaceutical
manufacturer'' means the holder of--
(A) an application approved under section 505(c) or
505(j) of the Federal Food, Drug, and Cosmetic Act, or
(B) a license under section 351(a) or 351(k) of the
Public Health Service Act.
(h) Rule of Construction.--Except to the extent this Act
establishes an additional basis for liability enforced as provided
herein, nothing in this Act shall modify, impair, limit, or supersede
the applicability of the antitrust laws, as defined in subsection (a)
of the 1st section of the Clayton Act (15 U.S.C. 12(a)), and of section
5(a) of the Federal Trade Commission Act (15 U.S.C. 45(a)). Nothing in
this Act shall be construed to limit the authority of the Federal Trade
Commission under any other provision of law.
(i) Severability.--If any provision of this Act, or the application
of such provision, to any person or circumstance is held to be
unconstitutional, the remainder of this Act, and the application of the
remaining provisions of this Act, to any person or circumstance shall
not be affected.
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