[Congressional Record Volume 148, Number 149 (Monday, November 18, 2002)]
[Senate]
[Pages S11339-S11342]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      DRUG COMPETITION ACT OF 2001

  Mr. REID. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 431, S. 754.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 754) 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.

  There being no objection, the Senate proceeded to consider the bill 
which had been reported from the Committee on the Judiciary, with an 
amendment to strike all after the enacting clause and insert in lieu 
thereof the following:
  [Strike the part shown in black brackets and insert the part shown in 
Italic.]

                                 S. 754

       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 
     2001''.

     [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 into 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 branded drugs and companies who 
     could manufacture generic or bioequivalent versions of such 
     branded 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.
       [(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'' is a product 
     that the Food and Drug Administration has approved under 
     section 505(j) of the Federal Food, Drug and Cosmetic Act.
       [(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) NDA.--The term ``NDA'' means a New Drug Application, 
     as defined under section 505(b) et seq. of the Federal Food, 
     Drug and Cosmetic Act (21 U.S.C. 355(b) et seq.)

     [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 regarding the sale 
     or manufacture of a generic drug equivalent of a brand name 
     drug that is manufactured by that brand name manufacturer and 
     which agreement could have the effect of limiting--
       [(1) the research, development, manufacture, marketing or 
     selling of a generic drug product that could be approved for 
     sale by the FDA pursuant to the ANDA; or
       [(2) the research, development, manufacture, marketing or 
     selling of a generic drug product that could be approved by 
     the FDA;
     [both shall file with the Commission and the Attorney General 
     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 FTC not later than 10 business days after the 
     date the agreements are 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, with the concurrence of the Assistant 
     Attorney General and by rule in accordance with section 553 
     of title 5, 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.]

     SECTION. 1. SHORT TITLE.

       This Act may be cited as the ``Drug Competition Act of 
     2001''.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) prescription drug prices are increasing at an alarming 
     rate and are a major worry of many senior citizens and 
     American families;
       (2) there is a potential for companies with patent rights 
     regarding brand name drugs and companies which could 
     manufacture generic versions of such drugs to enter into 
     financial deals that could tend to restrain trade and greatly 
     reduce competition and increase prescription drug 
     expenditures for American citizens; and
       (3) enhancing competition among these companies can 
     significantly reduce prescription drug expenditures for 
     Americans.

     SEC. 3. PURPOSES.

       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 with

[[Page S11340]]

     patent rights regarding brand name drugs and companies which 
     could manufacture generic versions of such drugs; and
       (2) by providing timely notice, to enhance the 
     effectiveness and efficiency of the enforcement of the 
     antitrust and competition laws of the United States.

     SEC. 4. DEFINITIONS.

       In this Act:
       (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
     Application, as defined under section 201(aa) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
       (2) Assistant attorney general.--The term ``Assistant 
     Attorney General'' means the Assistant Attorney General in 
     charge of the Antitrust Division of the Department of 
     Justice.
       (3) Brand name drug.--The term ``brand name drug'' means a 
     drug approved under section 505(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(c)).
       (4) Brand name drug company.--The term ``brand name drug 
     company'' means the party that received Food and Drug 
     Administration approval to market a brand name drug pursuant 
     to an NDA, where that drug is the subject of an ANDA, or a 
     party owning or controlling enforcement of any patent listed 
     in the Approved Drug Products With Therapeutic Equivalence 
     Evaluations of the Food and Drug Administration for that 
     drug, 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) Generic drug.--The term ``generic drug'' means a 
     product that the Food and Drug Administration has approved 
     under section 505(j) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)).
       (7) 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)).
       (8) NDA.--The term ``NDA'' means a New Drug Application, as 
     defined under section 505(b) et seq. of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(b) et seq.)

     SEC. 5. NOTIFICATION OF AGREEMENTS.

       (a) In General.--
       (1) Requirement.--A generic drug applicant that has 
     submitted an ANDA containing a certification under section 
     505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug 
     company that enter into an agreement described in paragraph 
     (2), prior to the generic drug that is the subject of the 
     application entering the market, shall each file the 
     agreement as required by subsection (b).
       (2) Definition.--An agreement described in this paragraph 
     is an agreement regarding--
       (A) the manufacture, marketing or sale of the brand name 
     drug that is the subject of the generic drug applicant's 
     ANDA;
       (B) the manufacture, marketing or sale of the generic drug 
     that is the subject of the generic drug applicant's ANDA; or
       (C) the 180-day period referred to in section 
     505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)(5)(B)(iv)) as it applies to such ANDA or to 
     any other ANDA based on the same brand name drug.
       (b) Filing.--
       (1) Agreement.--The generic drug applicant and the brand 
     name drug company entering into an agreement described in 
     subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any such agreement, 
     except that the generic drug applicant and the brand-name 
     drug company shall not be required to file an agreement that 
     solely concerns--
       (A) purchase orders for raw material supplies;
       (B) equipment and facility contracts; or
       (C) employment or consulting contracts.
       (2) Other agreements.--The generic drug applicant and the 
     brand name drug company entering into an agreement described 
     in subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any other agreements 
     not described in subsection (a)(2) between the generic drug 
     applicant and the brand name drug company which are 
     contingent upon, provide a contingent condition for, or are 
     otherwise related to an agreement which must be filed under 
     this Act.
       (3) Description.--In the event that any agreement required 
     to be filed by paragraph (1) or (2) has not been reduced to 
     text, both the generic drug applicant and the brand name drug 
     company shall file written descriptions of the non-textual 
     agreement or agreements that must be filed sufficient to 
     reveal all of the terms of the agreement or agreements.

     SEC. 6. FILING DEADLINES.

       Any filing required under section 5 shall be filed with the 
     Assistant Attorney General and the Commission not later than 
     10 business days after the date the agreements are executed.

     SEC. 7. DISCLOSURE EXEMPTION.

       Any information or documentary material filed with the 
     Assistant Attorney General or the Commission pursuant to this 
     Act shall be exempt from disclosure under section 552 of 
     title 5, and no such information or documentary material may 
     be made public, except as may be relevant to any 
     administrative or judicial action or proceeding. Nothing in 
     this section is intended to prevent disclosure to either body 
     of Congress or to any duly authorized committee or 
     subcommittee of the Congress.

     SEC. 8. ENFORCEMENT.

       (a) Civil Penalty.--Any brand name drug company or generic 
     drug applicant which fails to comply with any provision of 
     this Act shall be liable for a civil penalty of not more than 
     $11,000, for each day during which such entity 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 brand name 
     drug company or generic drug applicant fails to comply with 
     any provision 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 Assistant Attorney 
     General or the Commission. Equitable relief under this 
     subsection may include an order by the district court which 
     renders unenforceable, by the brand name drug company or 
     generic drug applicant failing to file, any agreement that 
     was not filed as required by this Act for the period of time 
     during which the agreement was not filed by the company or 
     applicant as required by this Act.

     SEC. 9. 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 define the terms used in this Act;
       (2) may exempt classes of persons or agreements from the 
     requirements of this Act; and
       (3) may prescribe such other rules as may be necessary and 
     appropriate to carry out the purposes of this Act.

     SEC. 10. SAVINGS CLAUSE.

       Any action taken by the Assistant Attorney General or the 
     Commission, or any failure of the Assistant Attorney General 
     or the Commission to take action, under this Act shall not 
     bar any proceeding or any action with respect to any 
     agreement between a brand name drug company and a generic 
     drug applicant at any time under any other provision of law, 
     nor shall any filing under this Act constitute or create a 
     presumption of any violation of any antitrust or competition 
     laws.

     SEC. 11. EFFECTIVE DATE.

       This Act shall--
       (1) take effect 30 days after the date of enactment of this 
     Act; and
       (2) shall apply to agreements described in section 5 that 
     are entered into 30 days after the date of enactment of this 
     Act.
  Mr. LEAHY. Mr. President, I am pleased that the Senate has, at long 
last, taken up the Drug Competition Act of 1002, S. 754. Prescription 
drug prices are rapidly increasing, and are a source of considerable 
concern to many Americans, especially senior citizens and families. 
Generic drug prices can be as much as 80 percent lower than the 
comparable brand name version.
  While the Drug Competition Act is a small bill in terms of length, it 
is a large one in terms of impact. It will ensure that law enforcement 
agencies can take quick and decisive action against companies that are 
driven more by greed than by good sense. It gives the Federal Trade 
Commission and the Justice Department access to information about 
secret deals between drug companies that keep generic drugs off the 
market. This is a practice that hurts American families, particularly 
senior citizens, by denying them access to low-cost generic drugs, and 
further inflating medical costs.
  This has been a genuine bipartisan effort, and I must thank all my 
colleagues, including Senator Hatch who has a long-standing interest in 
these issues, subcommittee Chairman Kohl who has worked with me from 
the start on this effort, and particularly Senator Grassley, who has 
worked hard to reach consensus on this bill that will help protect 
consumers.
  The issue of drug companies paying generic companies not to compete 
was exposed in recent years by the FTC, and by articles in major 
newspapers, including an editorial in the July 26, 2000, the New York 
Times, titled ``Driving Up Drug Prices.'' This editorial concluded that 
the problem ``needs help from Congress to close loopholes in federal 
law.'' And while the FTC has sued pharmaceutical companies that have 
made such secret and anticompetitive deals, as the then-Director of the 
Bureau of Competition Molly Boast testified before the Judiciary 
Committee in May 2001, the antitrust enforcement agencies are only 
finding out about such deals by luck, or by accident. Most recently, 
the FTC has issued a comprehensive study of the generic pharmaceutical 
industry which explicitly supported passage of S. 754.
  Under current law, the first generic manufacturer that gets 
permission to sell a generic drug before the patent on the brand-name 
drug expires, enjoys protection from competition for 180 days--a 
headstart on other generic companies. That was a good idea--but the 
unfortunate loophole exploited by a few is that secret deals can be 
made that allow the manufacturer of the generic drug to claim the 180-
day grace

[[Page S11341]]

period--to block other generic drugs from entering the market--while, 
at the same time, getting paid by the brand-name manufacturer to not 
sell the generic drug.
  The bill closes this loophole for those who want to cheat the public, 
but keeps the system the same for companies engaged in true 
competition. The deals would be reviewed only by those agencies--the 
agreements would not be available to the public. I think it is 
important for Congress not to overact and throw out the good with the 
bad. Most generic companies want to take advantage of this 180-day 
provision and deliver quality generic drugs at much lower costs for 
consumers. We should not eliminate the incentive for them. Instead, we 
should let the FTC and Justice look at every deal that could lead to 
abuse, so that only the deals that are consistent with the intent of 
that law will be allowed to stand. This bill accomplishes precisely 
that goal, and helps ensure effective and timely access to generic 
pharmaceuticals that can lower the cost of prescription drugs for 
seniors, for families, and for all of us.
  Mr. REID. Mr. President, I ask unanimous consent that the Hatch-Leahy 
amendment which is at the desk be agreed to; that the committee 
amendment, as amended, be agreed to; that the bill, as amended, be read 
the third time, passed, and the motion to reconsider be laid upon the 
table, with no intervening action or debate; and that any statements 
relating to the bill be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 4965) was agreed to, as follows:


                           amendment no. 4965

       On page 11, line 17, strike ``or''.
       On page 11, line 18, strike the period and insert ``; or''.
       On page 11, after line 18, insert the following: (D) 
     packaging and labeling contracts.
       On page 13, line 17, strike all beginning with 
     ``Equitable'' through line 23.
  The committee amendment in the nature of a substitute, as amended, 
was agreed to.
  The bill (S. 754), as amended, was read the third time and passed, as 
follows:

                                 S. 754

       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 
     2002''.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) prescription drug prices are increasing at an alarming 
     rate and are a major worry of many senior citizens and 
     American families;
       (2) there is a potential for companies with patent rights 
     regarding brand name drugs and companies which could 
     manufacture generic versions of such drugs to enter into 
     financial deals that could tend to restrain trade and greatly 
     reduce competition and increase prescription drug 
     expenditures for American citizens; and
       (3) enhancing competition among these companies can 
     significantly reduce prescription drug expenditures for 
     Americans.

     SEC. 3. PURPOSES.

       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 with patent rights regarding brand name drugs and 
     companies which could manufacture generic versions of such 
     drugs; and
       (2) by providing timely notice, to enhance the 
     effectiveness and efficiency of the enforcement of the 
     antitrust and competition laws of the United States.

     SEC. 4. DEFINITIONS.

       In this Act:
       (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
     Application, as defined under section 201(aa) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
       (2) Assistant attorney general.--The term ``Assistant 
     Attorney General'' means the Assistant Attorney General in 
     charge of the Antitrust Division of the Department of 
     Justice.
       (3) Brand name drug.--The term ``brand name drug'' means a 
     drug approved under section 505(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(c)).
       (4) Brand name drug company.--The term ``brand name drug 
     company'' means the party that received Food and Drug 
     Administration approval to market a brand name drug pursuant 
     to an NDA, where that drug is the subject of an ANDA, or a 
     party owning or controlling enforcement of any patent listed 
     in the Approved Drug Products With Therapeutic Equivalence 
     Evaluations of the Food and Drug Administration for that 
     drug, 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) Generic drug.--The term ``generic drug'' means a 
     product that the Food and Drug Administration has approved 
     under section 505(j) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)).
       (7) 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)).
       (8) NDA.--The term ``NDA'' means a New Drug Application, as 
     defined under section 505(b) et seq. of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(b) et seq.)

     SEC. 5. NOTIFICATION OF AGREEMENTS.

       (a) In General.--
       (1) Requirement.--A generic drug applicant that has 
     submitted an ANDA containing a certification under section 
     505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug 
     company that enter into an agreement described in paragraph 
     (2), prior to the generic drug that is the subject of the 
     application entering the market, shall each file the 
     agreement as required by subsection (b).
       (2) Definition.--An agreement described in this paragraph 
     is an agreement regarding--
       (A) the manufacture, marketing or sale of the brand name 
     drug that is the subject of the generic drug applicant's 
     ANDA;
       (B) the manufacture, marketing or sale of the generic drug 
     that is the subject of the generic drug applicant's ANDA; or
       (C) the 180-day period referred to in section 
     505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)(5)(B)(iv)) as it applies to such ANDA or to 
     any other ANDA based on the same brand name drug.
       (b) Filing.--
       (1) Agreement.--The generic drug applicant and the brand 
     name drug company entering into an agreement described in 
     subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any such agreement, 
     except that the generic drug applicant and the brand-name 
     drug company shall not be required to file an agreement that 
     solely concerns--
       (A) purchase orders for raw material supplies;
       (B) equipment and facility contracts;
       (C) employment or consulting contracts; or
       (D) packaging and labeling contracts.
       (2) Other agreements.--The generic drug applicant and the 
     brand name drug company entering into an agreement described 
     in subsection (a)(2) shall file with the Assistant Attorney 
     General and the Commission the text of any other agreements 
     not described in subsection (a)(2) between the generic drug 
     applicant and the brand name drug company which are 
     contingent upon, provide a contingent condition for, or are 
     otherwise related to an agreement which must be filed under 
     this Act.
       (3) Description.--In the event that any agreement required 
     to be filed by paragraph (1) or (2) has not been reduced to 
     text, both the generic drug applicant and the brand name drug 
     company shall file written descriptions of the non-textual 
     agreement or agreements that must be filed sufficient to 
     reveal all of the terms of the agreement or agreements.

     SEC. 6. FILING DEADLINES.

       Any filing required under section 5 shall be filed with the 
     Assistant Attorney General and the Commission not later than 
     10 business days after the date the agreements are executed.

     SEC. 7. DISCLOSURE EXEMPTION.

       Any information or documentary material filed with the 
     Assistant Attorney General or the Commission pursuant to this 
     Act shall be exempt from disclosure under section 552 of 
     title 5, and no such information or documentary material may 
     be made public, except as may be relevant to any 
     administrative or judicial action or proceeding. Nothing in 
     this section is intended to prevent disclosure to either body 
     of Congress or to any duly authorized committee or 
     subcommittee of the Congress.

     SEC. 8. ENFORCEMENT.

       (a) Civil Penalty.--Any brand name drug company or generic 
     drug applicant which fails to comply with any provision of 
     this Act shall be liable for a civil penalty of not more than 
     $11,000, for each day during which such entity 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 brand name 
     drug company or generic drug applicant fails to comply with 
     any provision 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 Assistant Attorney 
     General or the Commission.

     SEC. 9. 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 define the terms used in this Act;
       (2) may exempt classes of persons or agreements from the 
     requirements of this Act; and

[[Page S11342]]

       (3) may prescribe such other rules as may be necessary and 
     appropriate to carry out the purposes of this Act.

     SEC. 10. SAVINGS CLAUSE.

       Any action taken by the Assistant Attorney General or the 
     Commission, or any failure of the Assistant Attorney General 
     or the Commission to take action, under this Act shall not 
     bar any proceeding or any action with respect to any 
     agreement between a brand name drug company and a generic 
     drug applicant at any time under any other provision of law, 
     nor shall any filing under this Act constitute or create a 
     presumption of any violation of any antitrust or competition 
     laws.

     SEC. 11. EFFECTIVE DATE.

       This Act shall--
       (1) take effect 30 days after the date of enactment of this 
     Act; and
       (2) shall apply to agreements described in section 5 that 
     are entered into 30 days after the date of enactment of this 
     Act.

                          ____________________