Generic Substitution Noninterference Act
Bill: H.R.7473 | Sponsor: Rep. Maloney, Carolyn B. (D-NY)
Policy area: Health

Summary:
Generic Substitution Noninterference Act
This bill prohibits drug manufacturers from helping or directing health care providers to limit prescriptions to brand-name drugs when generic versions are available. The Federal Trade Commission and states may enforce this bill through civil actions.

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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