I

107TH CONGRESS

1ST SESSION H. R. 1862

To amend the Federal Food, Drug, and Cosmetic Act to provide greater

access to affordable pharmaceuticals.

IN THE HOUSE OF REPRESENTATIVES

MAY 16, 2001

Mr. BROWN of Ohio (for himself, Mrs. EMERSON, Mrs. THURMAN, Mr.

PALLONE, Mr. BALDACCI, Mr. STUPAK, Mr. SHOWS, Mr. ALLEN, Ms.

KAPTUR, Mr. SANDERS, and Mr. FRANK) introduced the following bill;

which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

provide greater access to affordable pharmaceuticals.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Greater Access to Af5 fordable Pharmaceuticals Act of 2001’’.

6 SEC. 2. FINDINGS; PURPOSES.

7 (a) FINDINGS.—Congress finds that—
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1 (1) prescription drug costs are increasing at an

2 alarming rate and are a major worry of American

3 families and senior citizens;

4 (2) enhancing competition between generic drug

5 manufacturers and brand-name manufacturers can

6 significantly reduce prescription drug costs for

7 American families;

8 (3) the pharmaceutical market has become in9 creasingly competitive during the last decade be10 cause of the increasing availability and accessibility

11 of generic pharmaceuticals, but competition must be

12 further stimulated and strengthened;

13 (4) the Federal Trade Commission has discov14 ered that there are increasing opportunities for drug

15 companies owning patents on brand-name drugs and

16 generic drug companies to enter into private finan17 cial deals in a manner that could restrain trade and

18 greatly reduce competition and increase prescription

19 drug costs for consumers;

20 (5) generic pharmaceuticals are approved by the

21 Food and Drug Administration on the basis of sci22 entific testing and other information establishing

23 that pharmaceuticals are therapeutically equivalent

24 to brand-name pharmaceuticals, ensuring consumers
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1 a safe, efficacious, and cost-effective alternative to

2 brand-name innovator pharmaceuticals;

3 (6) the Congressional Budget Office estimates

4 that—

5 (A) the use of generic pharmaceuticals for

6 brand-name pharmaceuticals could save pur7 chasers of pharmaceuticals between

8 $8,000,000,000 and $10,000,000,000 each

9 year; and

10 (B) generic pharmaceuticals cost between

11 25 percent and 60 percent less than brand12 name pharmaceuticals, resulting in an esti13 mated average savings of $15 to $30 on each

14 prescription;

15 (7) generic pharmaceuticals are widely accepted

16 by consumers and the medical profession, as the

17 market share held by generic pharmaceuticals com18 pared to brand-name pharmaceuticals has more than

19 doubled during the last decade, from approximately

20 19 percent to 43 percent, according to the Congres21 sional Budget Office;

22 (8) expanding access to generic pharmaceuticals

23 can help consumers, especially senior citizens and

24 the uninsured, have access to more affordable pre25 scription drugs;
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1 (9) Congress should ensure that measures are

2 taken to effectuate the amendments made by the

3 Drug Price Competition and Patent Term Restora4 tion Act of 1984 (98 Stat. 1585) (referred to in this

5 section as the ‘‘Hatch-Waxman Act’’) to make ge6 neric drugs more accessible, and thus reduce health

7 care costs; and

8 (10) it would be in the public interest if patents

9 on drugs for which applications are approved under

10 section 505(c) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355(c)) were extended only

12 through the patent extension procedure provided

13 under the Hatch-Waxman Act rather than through

14 the attachment of riders to bills in Congress.

15 (b) PURPOSES.—The purposes of this Act are—

16 (1) to increase competition, thereby helping all

17 Americans, especially seniors and the uninsured, to

18 have access to more affordable medication; and

19 (2) to ensure fair marketplace practices and

20 deter pharmaceutical companies (including generic

21 companies) from engaging in anticompetitive action

22 or actions that tend to unfairly restrain trade.
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1 SEC. 3. ACCELERATED GENERIC DRUG COMPETITION.

2 (a) IN GENERAL.—Section 505(j)(5) of the Federal

3 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is

4 amended—

5 (1) in subparagraph (B)(iv), by striking sub6 clause (II) and inserting the following:

7 ‘‘(II) the earlier of—

8 ‘‘(aa) the date of a final decision of a

9 court in an action described in clause (iii)

10 (from which no appeal can or has been

11 taken); or

12 ‘‘(bb) the date of a settlement order

13 or consent decree signed by a Federal

14 judge that enters a final judgment and in15 cludes a finding that the patents that are

16 the subject of the certification are invalid

17 or not infringed;’’;

18 (2) by redesignating subparagraphs (C) and

19 (D) as subparagraphs (E) and (F), respectively; and

20 (3) by inserting after subparagraph (B) the fol21 lowing:

22 ‘‘(C) FORFEITURE OF 180-DAY PERIOD.—

23 ‘‘(i) IN GENERAL.—The 180-day pe24 riod described in subparagraph (B)(iv)

25 shall be forfeited by the previous applicant

26 and become available to the next applicant
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1 submitting an application containing a cer2 tification described in paragraph

3 (2)(A)(vii)(IV) if—

4 ‘‘(I) the previous applicant fails

5 to market the drug within 90 days

6 after the date on which the approval

7 of the application for the drug is

8 made effective under subparagraph

9 (B)(iii);

10 ‘‘(II) the previous applicant with11 draws the application;

12 ‘‘(III) the previous applicant

13 amends the certification from a cer14 tification under subclause (IV) to a

15 certification under paragraph

16 (2)(A)(vii)(III), either voluntarily or

17 as a result of a settlement or defeat in

18 patent litigation;

19 ‘‘(IV) the previous applicant fails

20 to get tentative approval of the appli21 cation within 30 months after the

22 date on which the application is filed,

23 unless the failure is caused by—

24 ‘‘(aa) a change in the re25 quirements for tentative approval
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1 of the application imposed after

2 the date on which the application

3 was filed; or

4 ‘‘(bb) other extraordinary or

5 unusual circumstances, as deter6 mined by the Secretary;

7 ‘‘(V) in a case in which, after the

8 date on which the previous application

9 was submitted under this subsection,

10 new patent information is submitted

11 for the drug under subsection (c)(2)

12 for a patent for which certification is

13 required under paragraph

14 (2)(A)(vii)(IV), the previous applicant

15 fails to challenge the patent that is

16 the subject of the information within

17 60 days after the date on which the

18 patent information is submitted; or

19 ‘‘(VI) the previous applicant is

20 determined by the Secretary, after a

21 fair and sufficient hearing and in con22 sultation with the Federal Trade

23 Commission, to have engaged in anti24 competitive or collusive conduct, or

25 any other conduct intended to unfairly
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1 monopolize the commercial manufac2 turing of the drug of the application.

3 ‘‘(ii) AVAILABILITY.—The 180-day pe4 riod described in subparagraph (B)(iv)

5 shall be available only to—

6 ‘‘(I) the previous applicant sub7 mitting an application for a drug

8 under this subsection containing a

9 certification described in paragraph

10 (2)(A)(vii)(IV) with respect to any

11 patent; or

12 ‘‘(II) under clause (i), the next

13 applicant submitting an application

14 for a drug under this subsection con15 taining such a certification with re16 spect to any patent;

17 even if an application has been submitted

18 for the drug under this subsection con19 taining such a certification with respect to

20 a different patent.

21 ‘‘(iii) APPLICABILITY.—The 180-day

22 period described in subparagraph (B)(iv)

23 shall apply only if—
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1 ‘‘(I) the application contains a

2 certification described in paragraph

3 (2)(A)(vii)(IV); and

4 ‘‘(II) an action is brought for in5 fringement of a patent that is the

6 subject of the certification or the ap7 plicant brings an action (not later

8 than 50 days after the date on which

9 the notice provided under paragraph

10 (2)(B)(ii) was received), against the

11 holder of the approved application for

12 the listed drug.’’.

13 (b) EFFECTIVE DATE.—The amendment made by

14 this section shall be effective only with respect to an appli15 cation filed under section 505(j) of the Federal Food,

16 Drug, and Cosmetic Act (21 U.S.C. 355(j)) for a listed

17 drug for which no certification under section

18 505(j)(2)(A)(vii)(IV) of that Act was made before the date

19 of enactment of this Act.

20 SEC. 4. BIOEQUIVALENCE TESTING METHODS.

21 Section 505(j)(8)(B) of the Federal Food, Drug, and

22 Cosmetic Act (21 U.S.C. 355(j)(8)(B)) is amended—

23 (1) in clause (i), by striking ‘‘or’’ at the end;

24 (2) in clause (ii), by striking the period at the

25 end and inserting ‘‘; or’’; and
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1 (3) by adding at the end the following:

2 ‘‘(iii)(I) clauses (i) and (ii) are not applica3 ble, as determined by the Secretary;

4 ‘‘(II) the effects of the drug and the listed

5 drug do not show a significant difference based

6 on tests (other than tests that assess rate and

7 extent of absorption), including—

8 ‘‘(aa) a bioequivalence study with a

9 pharmacodynamic endpoint;

10 ‘‘(bb) a bioequivalence study with a

11 clinical endpoint;

12 ‘‘(cc) in vitro methods; or

13 ‘‘(dd) any other methodology that

14 demonstrates that no significant dif15 ferences in therapeutic effects of active in16 gredients are expected; and

17 ‘‘(III) limited confirmatory studies to sup18 plement the bioequivalence testing are consid19 ered necessary by the Secretary.’’.

20 SEC. 5. CITIZEN PETITIONS.

21 Section 505(j)(5) of the Federal Food, Drug, and

22 Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by sec23 tion 3(a)) is amended by inserting after subparagraph (C)

24 the following:

25 ‘‘(D) CITIZEN PETITIONS.—
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1 ‘‘(i) IN GENERAL.—Notwithstanding

2 any other provision of law, any petition

3 submitted under section 10.30 of title 21,

4 Code of Federal Regulations (or any suc5 cessor regulation), shall include a state6 ment that to the best knowledge and belief

7 of the petitioner, the petition—

8 ‘‘(I) includes all information and

9 views on which the petitioner relies;

10 ‘‘(II) is well grounded in fact and

11 is warranted by law (including regula12 tions);

13 ‘‘(III) is not submitted for any

14 improper purpose, such as to harass

15 or cause unnecessary delay;

16 ‘‘(IV) does not contain a materi17 ally false, misleading, or fraudulent

18 statement that the petitioner has

19 knowingly and willingly included; and

20 ‘‘(V) includes all representative

21 data and information known to the

22 petitioner that is favorable or unfavor23 able to the petition.

24 ‘‘(ii) APPLICABILITY OF CRIMINAL

25 PROVISION.—Section 1001 of title 18,
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1 United States Code, shall apply to a per2 son that submits a petition under section

3 10.30 of title 21, Code of Federal Regula4 tions (or any successor regulation).

5 ‘‘(iii) INVESTIGATIONS.—

6 ‘‘(I) IN GENERAL.—The Federal

7 Trade Commission shall investigate,

8 on receipt of a complaint or upon its

9 own initiative, any petition submitted

10 under section 10.30 of title 21, Code

11 of Federal Regulations (or any suc12 cessor regulation), that may have been

13 submitted for an improper purpose,

14 such as to delay competition or agen15 cy action.

16 ‘‘(II) REFERRAL.—If the Com17 mission finds that a petitioner has en18 gaged in conduct that may be illegal,

19 the Commission shall refer the peti20 tion to the Antitrust Division of the

21 Department of Justice for further ac22 tion.

23 ‘‘(iv) NOTICE OF RECEIPT OF CONSID24 ERATION.—
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1 ‘‘(I) IN GENERAL.—A person

2 that submits a petition under section

3 10.30 of title 21, Code of Federal

4 Regulations (or any successor regula5 tion), shall provide a written notice to

6 the Federal Trade Commission if the

7 person receives any consideration for

8 submitting the petition.

9 ‘‘(II) A notice under subclause

10 (I) shall include—

11 ‘‘(aa) the name of the per12 son or entity that provided the

13 consideration;

14 ‘‘(bb) the dollar value of the

15 consideration, if provided in cash,

16 or a description of such consider17 ation;

18 ‘‘(cc) the date on which the

19 consideration was provided; and

20 ‘‘(dd) any other information

21 that the Commission requires to

22 be disclosed.’’.

23 SEC. 6. PATENT CERTIFICATION.

24 (a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec25 tion 505(j)(5) of the Federal Food, Drug, and Cosmetic
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1 Act (21 U.S.C. 355(j)(5)) (as amended by section 3(a)(2))

2 is amended—

3 (1) in subparagraph (B), by striking clause (iii)

4 and inserting the following:

5 ‘‘(iii) CERTIFICATION THAT PATENT

6 IS INVALID OR WILL NOT BE INFRINGED.—

7 ‘‘(I) IN GENERAL.—Except as

8 provided in subclauses (II) and (III),

9 if the applicant made a certification

10 described in paragraph

11 (2)(A)(vii)(IV), the approval shall be

12 made effective on the expiration of 45

13 days after the date on which the no14 tice provided under paragraph

15 (2)(B)(ii) was received.

16 ‘‘(II) ACTION FOR PATENT IN17 FRINGEMENT.—If an action is

18 brought for infringement of a patent

19 that is the subject of the certification

20 before the expiration of the 45-day pe21 riod beginning on the date on which

22 the notice provided under paragraph

23 (2)(B)(ii) was received, the approval

24 shall be made effective on the expira25 tion of the 45-day period unless the
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1 court grants a preliminary injunction

2 prohibiting the applicant from engag3 ing in the commercial manufacture or

4 sale of the drug until the court de5 cides the issues of patent validity and

6 infringement.

7 ‘‘(III) PATENT INVALID OR NOT

8 INFRINGED.—If the court decides that

9 the patent is invalid or was not in10 fringed, the approval shall be made ef11 fective on the date of the court deci12 sion.

13 ‘‘(IV) PATENT INFRINGED.—If

14 the court decides that the patent was

15 infringed, the approval shall be made

16 effective on such date as the court or17 ders under section 271(e)(4)(A) of

18 title 35, United States Code.

19 ‘‘(V) PROCEDURE.—In an action

20 described in subclause (II)—

21 ‘‘(aa) each of the parties

22 shall reasonably cooperate in ex23 pediting the action;

24 ‘‘(bb) until the expiration of

25 45 days after the date the notice
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1 provided under paragraph

2 (2)(B)(i) was received, no civil

3 action may be brought under sec4 tion 2201 of title 28, United

5 States Code, for a declaratory

6 judgment with respect to the pat7 ent, except as provided in sub8 paragraph (H); and

9 ‘‘(cc) any such civil action

10 shall be brought in the judicial

11 district in which the defendant

12 has its principal place of business

13 or a regular and established place

14 of business.’’; and

15 (2) by adding at the end the following:

16 ‘‘(G) CIVIL ACTION FOR DECLARATORY

17 JUDGMENT.—A person that files an abbreviated

18 application for a new drug under this para19 graph may bring a civil action against the hold20 er of an approved application for a listed drug

21 for a declaratory judgment to determine wheth22 er the patent that claims the listed drug or a

23 method of using the drug is invalid or will not

24 be infringed.
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1 ‘‘(H) CIVIL ACTION TO DETERMINE LEGAL

2 STATUS.—Notwithstanding any other provision

3 of law, if information on a patent for a listed

4 drug has been published under subsection (c)(2)

5 for at least 1 year after the date on which an

6 abbreviated application for approval of a new

7 drug was filed under this subsection in relation

8 to the listed drug, the person that filed the ab9 breviated application or the holder of the ap10 proved application for the listed drug may im11 mediately bring a civil action to determine the

12 legal status of the patent for the listed drug.’’.

13 (b) NEW DRUG APPLICATIONS.—Section 505(c)(3)

14 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

15 355(c)(3)) is amended by striking subparagraph (C) and

16 inserting the following:

17 ‘‘(C) CERTIFICATION THAT PATENT IS IN18 VALID OR WILL NOT BE INFRINGED.—

19 ‘‘(i) IN GENERAL.—Except as pro20 vided in clauses (ii) and (iii), if the appli21 cant made a certification described in sub22 section (b)(2)(A)(iv), the approval shall be

23 made effective on the expiration of 45 days

24 after the date on which the notice provided

25 under subsection (b)(3)(B) was received.
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1 ‘‘(ii) ACTION BROUGHT BEFORE EXPI2 RATION OF 45 DAYS.—If an action is

3 brought for infringement of a patent that

4 is the subject of the certification before the

5 expiration of the 45-day period beginning

6 on the date the notice provided under sub7 section (b)(3)(B) was received, the ap8 proval shall be made effective on the expi9 ration of the 45-day period unless the

10 court grants a preliminary injunction pro11 hibiting the applicant from engaging in the

12 commercial manufacture or sale of the

13 drug until the court decides the issues of

14 patent validity and infringement.

15 ‘‘(iii) PATENT INVALID OR NOT IN16 FRINGED.—If the court decides that the

17 patent is invalid or not infringed, the ap18 proval shall be made effective on the date

19 of the court decision.

20 ‘‘(iv) PATENT INFRINGED.—If the

21 court decides that the patent has been in22 fringed, the approval may be made effec23 tive on such date as the court orders under

24 section 271(e)(4)(A) of title 35, United

25 States Code.
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1 ‘‘(v) PROCEDURE.—In an action de2 scribed in clause (ii)—

3 ‘‘(I) each of the parties shall rea4 sonably cooperate in expediting the

5 action;

6 ‘‘(II) until the expiration of 45

7 days after the date the notice provided

8 under subsection (b)(3)(B) was re9 ceived, no civil action may be brought

10 under section 2201 of title 28, United

11 States Code, for a declaratory judg12 ment with respect to the patent, ex13 cept as provided in subsection

14 (j)(5)(H); and

15 ‘‘(III) any such civil action shall

16 be brought in the judicial district

17 where the defendant has its principal

18 place of business or a regular and es19 tablished place of business.’’.

20 (c) EFFECTIVE DATE.—The amendments made by

21 this section shall not apply to an application submitted

22 under section 505 of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 355) before the date of enactment

24 of this Act.
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1 SEC. 7. PATENT INFORMATION.

2 Section 505 of the Federal Food, Drug, and Cosmetic

3 Act (21 U.S.C. 355) is amended—

4 (1) in subsection (b), by striking ‘‘(b)(1) Any

5 person’’ and all that follows through paragraph (1)

6 and inserting the following:

7 ‘‘(b) APPLICATIONS.—

8 ‘‘(1) IN GENERAL.—

9 ‘‘(A) FILING.—Any person may file with

10 the Secretary an application with respect to any

11 drug subject to subsection (a).

12 ‘‘(B) CONTENTS.—A person that files an

13 application shall submit to the Secretary as a

14 part of the application with respect to a drug—

15 ‘‘(i) full reports of investigations that

16 have been made to show whether or not

17 such drug is safe for use and whether the

18 drug is effective in use;

19 ‘‘(ii) a full list of the articles used as

20 components of the drug;

21 ‘‘(iii) a full statement of the composi22 tion of the drug;

23 ‘‘(iv) a full description of the methods

24 used in, and the facilities and controls

25 used for, the manufacture, processing, and

26 packing of the drug;
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1 ‘‘(v) such samples of the drug and of

2 the articles used as components of the

3 drug as the Secretary may require; and

4 ‘‘(vi) specimens of the labeling pro5 posed to be used for the drug.

6 ‘‘(C) PATENT INFORMATION.—

7 ‘‘(i) IN GENERAL.—The applicant

8 shall file with the application the patent

9 number and expiration date of any patent

10 that claims a drug or method of using a

11 drug and with respect to which a claim of

12 patent infringement could reasonably be

13 asserted if a person not licensed by the

14 owner engaged in the manufacture, use, or

15 sale of the drug for which the applicant

16 submitted the application.

17 ‘‘(ii) AMENDMENT OF APPLICATION.—

18 If an application is filed with respect to a

19 drug and a patent as described in clause

20 (i) is issued after the filing date but before

21 approval of the application, the applicant

22 shall amend the application to include the

23 information required by clause (i).

24 ‘‘(iii) PUBLICATION OF INFORMA25 TION.—On approval of the application, the
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1 Secretary shall publish information sub2 mitted under clauses (i) and (ii).

3 ‘‘(D) GUIDANCE.—The Secretary shall, in

4 consultation with the Director of the National

5 Institutes of Health and with representatives of

6 the drug manufacturing industry, review and

7 develop guidance, as appropriate, on the inclu8 sion of women and minorities in clinical trials

9 required by subparagraph (B)(i).’’; and

10 (2) in paragraph (2)(A)—

11 (A) by striking ‘‘which claims’’ the first

12 place it appears and all that follows through

13 ‘‘subsection and’’; and

14 (B) by striking ‘‘subsection (c)—’’ and in15 serting ‘‘and with respect to which a claim of

16 patent infringement could reasonably be as17 serted if a person not licensed by the owner en18 gaged in the manufacture, use, or sale of the

19 drug for which the investigations were con20 ducted—’’;

21 (3) in the first sentence of subsection (c)(2)—

22 (A) by inserting ‘‘such patent information’’

23 after ‘‘shall file’’; and

24 (B) by striking ‘‘Secretary,’’ and all that

25 follows and inserting ‘‘Secretary.’’;
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1 (4) in subsection (j)(2)(vii), by striking ‘‘which

2 claims the listed drug’’ and all that follows through

3 ‘‘under this subsection and’’ and inserting ‘‘for the

4 listed drug referred to in clause (i)’’; and

5 (5) by adding at the end the following:

6 ‘‘(o) PATENT INFORMATION.—

7 ‘‘(1) APPLICABILITY.—This subsection applies

8 to a holder of an approved application under sub9 section (c) that files a patent—

10 ‘‘(A) that claims, with regard to a drug of

11 the application, a drug or method of using a

12 drug; and

13 ‘‘(B) for which a claim of patent infringe14 ment could reasonably be asserted if a person

15 not licensed by the owner engaged in the manu16 facture, use, or sale of the drug, after the date

17 of approval of the application.

18 ‘‘(2) CERTIFICATION.—A holder of a patent de19 scribed in paragraph (1) shall—

20 ‘‘(A) inform the Secretary of the filing of

21 the patent; and

22 ‘‘(B) certify that the information is a com23 plete and accurate listing of all such patents.
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1 ‘‘(3) SECRETARY.—The Secretary shall list the

2 information provided under paragraph (2) in accord3 ance with subsection (j)(7).’’.

4 SEC. 8. REPORT.

5 (a) IN GENERAL.—Not later than the date that is

6 5 years after the date of enactment of this Act, the Fed7 eral Trade Commission shall submit to Congress a report

8 describing the extent to which implementation of the

9 amendments made by this Act—

10 (1) has enabled products to come to market in

11 a fair and expeditious manner, consistent with the

12 rights of patent owners under intellectual property

13 law; and

14 (2) has promoted lower prices of drugs and

15 greater access to drugs through price competition.

16 (b) AUTHORIZATION OF APPROPRIATIONS.—There is

17 authorized to be appropriated to carry out this section

18 $5,000,000.

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