[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5313 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 5313

To enhance competition for prescription drugs by increasing the ability 
 of the Department of Justice and Federal Trade Commission to enforce 
 existing antitrust laws regarding brand name drugs and generic drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 27, 2000

 Mr. Andrews introduced the following bill; which was referred to the 
    Committee on Commerce, and in addition to the Committee on the 
 Judiciary, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To enhance competition for prescription drugs by increasing the ability 
 of the Department of Justice and Federal Trade Commission to enforce 
 existing antitrust laws regarding brand name drugs and generic 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 ``Drug Competition Act of 2000''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) prescription drug costs are increasing at an alarming 
        rate and are a major worry of senior citizens and American 
        families;
            (2) there is a potential for drug companies owning patents 
        on brand-name drugs to enter in private financial deals with 
        generic drug companies in a manner that could tend to restrain 
        trade and greatly reduce competition and increase prescription 
        drug costs for American citizens; and
            (3) enhancing competition between generic drug 
        manufacturers and brand name manufacturers can significantly 
        reduce prescription drug costs to American families.

SEC. 3. PURPOSE.

    The purposes of this Act are--
            (1) to provide timely notice to the Department of Justice 
        and the Federal Trade Commission regarding agreements between 
        companies owning patents on brand name drugs and companies who 
        could manufacture generic or bioequivalent versions of such 
        brand name drugs; and
            (2) by providing timely notice, to--
                    (A) enhance the effectiveness and efficiency of the 
                enforcement of the antitrust laws of the United States; 
                and
                    (B) deter pharmaceutical companies from engaging in 
                anticompetitive actions or actions that tend to 
                unfairly restrain trade.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) Agreement.--The term ``agreement'' means an agreement 
        under section 1 of the Sherman Act (15 U.S.C. 1) or section 5 
        of the Federal Trade Commission Act (15 U.S.C. 45).
            (2) Antitrust laws.-- The term ``antitrust laws'' has the 
        same meaning as in section 1 of the Clayton Act (15 U.S.C. 12), 
        except that such term includes section 5 of the Federal Trade 
        Commission Act (15 U.S.C. 45) to the extent that such section 
        applies to unfair methods of competition.
            (3) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
        Application, as defined under section 505(j) of the Federal 
        Food, Drug and Cosmetic Act (21 U.S.C 355(j)).
            (4) Brand name drug company.--The term ``brand name drug 
        company'' means a person engaged in the manufacture or 
        marketing of a drug approved under section 505(b) of the 
        Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(b)).
            (5) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (6) FDA.--The term ``FDA'' means the United States Food and 
        Drug Administration.
            (7) Generic drug.--The term ``generic drug'' is a product 
        that the Food and Drug Administration has approved under 
        section 505(j) of the Federal Food, Drug and Cosmetic Act (221 
        U.S.C. 355(j)).
            (8) Generic drug applicant.--The term ``generic drug 
        applicant'' means a person who has filed or received approval 
        for an ANDA under section 505(j) of the Federal Food, Drug and 
        Cosmetic Act (21 U.S.C. 355(j)).
            (9) NDA.--The term ``NDA'' means a New Drug Application, as 
        defined under section 505(b) of the Federal Food, Drug and 
        Cosmetic Act (21 U.S.C. 355(b))

SEC. 5. NOTIFICATION OF AGREEMENTS AFFECTING THE SALE OR MARKETING OF 
              GENERIC DRUGS.

    A brand name drug manufacturer and a generic drug manufacturer that 
enter into an agreement--
            (1) regarding the sale or manufacture of a generic drug 
        equivalent of a brand name drug that is manufactured by that 
brand name manufacturer. and
            (2) which agreement could have the effect of limiting the 
        research, development, manufacture, marketing or selling of a 
        generic drug product that could be approved for sale by the FDA 
        pursuant to an ANDA,
shall both file with the Commission and the Attorney General a notice 
that such an agreement has been entered into, the text of the 
agreement, an explanation of the purpose and scope of the agreement, 
and an explanation of whether the agreement could delay, restrain, 
limit, or in any way interfere with the production, manufacture, or 
sale of the generic version of the drug in question.

SEC. 6. FILING DEADLINES.

    Any notice, agreement, or other material required to be filed under 
section 5 shall be filed with the Attorney General and the Commission 
not later than 10 business days after the date the agreement is 
executed.

SEC. 7. ENFORCEMENT.

    (a) Civil Fine.--Any person, or any officer, director, or partner 
thereof, who fails to comply with any provision of this Act shall be 
liable for a civil penalty of not more than $20,000 for each day during 
which such person is in violation of this Act. Such penalty may be 
recovered in a civil action brought by the United States or brought by 
the Commission in accordance with the procedures established in section 
16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
    (b) Compliance and Equitable Relief.--If any person, or any 
officer, director, partner, agent, or employee thereof, fails to comply 
with the notification requirement under section 5 of this Act, the 
United States district court, for the district in which such person 
officer, director, partner, agent, or employee thereof resides or does 
business, may order compliance and grant such other equitable relief as 
the court in its discretion determines necessary or appropriate, upon 
application of the Commission or the Assistant Attorney General.

SEC. 8. RULEMAKING.

    The Commission, with the concurrence of the Assistant Attorney 
General and by rule in accordance with section 553 of title 5, United 
States Code, consistent with the purposes of this Act--
            (1) may require that the notice of an agreement described 
        in section 5 of this Act be in such form and contain such 
        documentary material and information relevant to the agreement 
        as is necessary and appropriate to enable the Commission and 
        the Assistant Attorney General to determine whether such 
        agreement may violate the antitrust laws;
            (2) may define the terms used in this Act;
            (3) may exempt classes of persons or agreements from the 
        requirements of this Act; and
            (4) may prescribe such other rules as may be necessary and 
        appropriate to carry out the purposes of this Act.

SEC. 9. EFFECTIVE DATES.

    This Act shall take effect 90 days after the date of enactment of 
this Act.
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