```

[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5235 Introduced in House (IH)]

106th CONGRESS
  2d Session
                                H. R. 5235

To ensure the timely availability of generic drugs through enhancement 
   of drug approval and antitrust laws enforced by the Food and Drug 
 Administration and the Federal Trade Commission regarding brand name 
                        drugs and generic drugs.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 20, 2000

 Mr. Waxman (for himself, Mr. Stark, Mr. Brown of Ohio, Mr. Berry, Mr. 
   Coburn, and Mr. Deutsch) 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 ensure the timely availability of generic drugs through enhancement 
   of drug approval and antitrust laws enforced by the Food and Drug 
 Administration and the Federal Trade Commission 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 ``Prescription 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 concern of senior citizens and American 
        families;
            (2) there is a potential for drug companies owning patents 
        on brand-name drugs to enter to 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 Food and Drug 
        Administration and the Federal Trade Commission regarding 
        agreements between companies owning patents on branded drugs 
        and companies who could manufacture generic or bioequivalent 
        versions of such branded drugs; and
            (2) by providing timely notice, to--
                    (A) ensure the prompt availability of safe and 
                effective generic drugs;
                    (B) enhance the effectiveness and efficiency of the 
                enforcement of the antitrust laws of the United States; 
                and
                    (C) 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.
            (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.
            (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'' means a 
        product that is the subject of an ANDA.
            (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.
            (9) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

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

    A brand name drug company and a generic drug applicant that enter 
into an agreement regarding the sale or manufacture of a generic drug 
that the Secretary has determined is the therapeutic equivalent of a 
brand name drug that is manufactured or marketed by that brand name 
drug company, or for which the generic drug applicant seeks such a 
determination of therapeutic equivalence, and which agreement could 
have the effect of limiting the research, development, manufacture, 
marketing, or selling of a generic drug that has been or could be 
approved for sale by the FDA pursuant to an ANDA, shall file with the 
Commission and the Secretary 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 Commission and the Secretary 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 may order compliance, and may 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, in consultation with the Secretary, and 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 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.
                                 <all>
```