II

106TH CONGRESS

2D SESSION S. 3051

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

access to affordable pharmaceuticals.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 14, 2000

Mr. SCHUMER (for himself, Mr. MCCAIN, and Mr. JOHNSON) introduced the

following bill; which was read twice and referred to the Committee on

Health, Education, Labor, and Pensions

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’’ or the ‘‘GAAP Act of

6 2000’’.

7 SEC. 2. NEW DRUG APPLICATIONS.

8 (a) LIMITATIONS ON THE USE OF PATENTS TO PRE9 VENT APPROVAL OF ABBREVIATED NEW DRUG APPLICA-
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1 TIONS.—Section 505(b)(2) of the Federal Food, Drug,

2 and Cosmetic Act (21 U.S.C. 355(b)(2)) is amended—

3 (1) in subparagraph (A)—

4 (A) in the matter preceding clause (i), by

5 striking ‘‘the drug for which such investigations

6 were conducted or which claims a use for such

7 drug for which the applicant is seeking approval

8 under this subsection’’ and inserting ‘‘an active

9 ingredient of the drug for which such investiga10 tions were conducted, alone or in combination

11 with another active ingredient or which claims

12 the first approved use for such drug for which

13 the applicant is seeking approval under this

14 subsection’’; and

15 (B) in clause (iv), by striking ‘‘; and’’ and

16 inserting a period;

17 (2) in the matter preceding subparagraph (A),

18 by striking ‘‘shall also include—’’ and all that fol19 lows through ‘‘a certification’’ and inserting ‘‘shall

20 also include a certification’’;

21 (3) by striking subparagraph (B); and

22 (4) by redesignating clauses (i) through (iv) as

23 subparagraphs (A) through (D), respectively, and

24 aligning the margins of the subparagraphs with the
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1 margins of subparagraph (A) of section 505(c)(1) of

2 that Act (21 U.S.C. 355(c)(1)).

3 (b) ABBREVIATED NEW DRUG APPLICATIONS.—Sec4 tion 505(j)(2)(A) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(j)(2)(A)) is amended—

6 (1) in clause (vi), by striking the semicolon and

7 inserting ‘‘; and’’; and

8 (2) in clause (vii)—

9 (A) in the matter preceding subclause (I),

10 by striking ‘‘the listed drug referred to in clause

11 (i) or which claims a use for such listed drug

12 for which the applicant is seeking approval

13 under this subsection’’ and inserting ‘‘an active

14 ingredient of the listed drug referred to in

15 clause (i), alone or in combination with another

16 active ingredient or which claims the first ap17 proved use for such drug for which the appli18 cant is seeking approval under this subsection’’;

19 (B) in subclause (IV), by striking ‘‘; and’’

20 and inserting a period; and

21 (C) by striking clause (viii).

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

23 this section shall only be effective with respect to a listed

24 drug for which no certification pursuant to section
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1 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, Cosmetic

2 Act was made prior to the date of enactment of this Act.

3 SEC. 3. CITIZEN PETITION REVIEW.

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

5 Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—

6 (1) by redesignating subparagraphs (C) and

7 (D) as subparagraphs (D) and (E), respectively; and

8 (2) by inserting after subparagraph (B) the fol9 lowing:

10 ‘‘(C) Notwithstanding any other provision of law, the

11 submission of a citizen’s petition filed pursuant to section

12 10.30 of title 21, Code of Federal Regulations, with re13 spect to an application submitted under paragraph (2)(A),

14 shall not cause the Secretary to delay review and approval

15 of such application, unless such petition demonstrates

16 through substantial scientific proof that approval of such

17 application would pose a threat to public health and safe18 ty.’’.

19 SEC. 4. BIOEQUIVALENCE TESTING METHODS.

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

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

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

23 (2) in clause (ii), by striking the period and in24 serting ‘‘; or’’; and

25 (3) by adding at the end the following:
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1 ‘‘(iii) the effects of the drug and the listed

2 drug do not show a significant difference based

3 on tests (other than tests that assess rate and

4 extent of absorption), including comparative

5 pharmacodynamic studies, limited confirmation

6 studies, or in vitro methods, that demonstrate

7 that no significant differences in therapeutic ef8 fects of active or inactive ingredients are ex9 pected.’’.

10 SEC. 5. ACCELERATED GENERIC DRUG COMPETITION.

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

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

13 amended—

14 (1) in subparagraph (B)(iv), by striking sub15 clause (II) and inserting the following:

16 ‘‘(II) the date of a final decision of a court

17 in an action described in clause (ii) from which

18 no appeal can or has been taken, or the date of

19 a settlement order or consent decree signed by

20 a Federal judge, that enters a final judgement,

21 and includes a finding that the relevant patents

22 that are the subject of the certification involved

23 are invalid or not infringed, whichever is ear24 lier,’’;
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1 (2) by redesignating subparagraphs (C) and

2 (D) as subparagraphs (D) and (E), respectively; and

3 (3) by inserting after subparagraph (B), the

4 following:

5 ‘‘(C) The one-hundred and eighty day period de6 scribed in subparagraph (B)(iv) shall become available to

7 the next applicant submitting an application containing a

8 certification described in paragraph (2)(A)(vii)(IV) if the

9 previous applicant fails to commence commercial mar10 keting of its drug product once its application is made ef11 fective, withdraws its application, or amends the certifi12 cation from a certification under subclause (IV) to a cer13 tification under subclause (III) of such paragraph, either

14 voluntarily or as a result of a settlement or defeat in pat15 ent litigation.’’.

16 (b) EFFECTIVE DATE.—The amendments made by

17 this section shall only be effective with respect to an appli18 cation filed under section 505(j) of the Federal Food,

19 Drug, Cosmetic Act for a listed drug for which no certifi20 cation pursuant to 505(j)(2)(A)(vii)(IV) of such Act was

21 made prior to the date of enactment of this Act.

22 SEC. 6. SENSE OF CONGRESS.

23 It is the sense of Congress that measures should be

24 taken to effectuate the purpose of the Drug Price Com25 petition and Patent Term Restoration Act of 1984 (re-
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1 ferred to in this section as the ‘‘Hatch-Waxman Act’’) to

2 make generic drugs more available and accessible, and

3 thereby reduce health care costs, including measures that

4 require manufacturers of a drug for which an application

5 is approved under section 505(c) of the Federal Food,

6 Drug, and Cosmetic Act (21 U.S.C. 255(c)) desiring to

7 extend a patent of such drug to utilize the patent exten8 sion procedure provided under the Hatch-Waxman Act.

9 SEC. 7. CONFORMING AMENDMENTS.

10 (a) APPLICATIONS.—Section 505 of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 355) is

12 amended—

13 (1) in subsection (b)(3), in subparagraphs (A)

14 and (C), by striking ‘‘paragraph (2)(A)(iv)’’ and in15 serting ‘‘paragraph (2)’’;

16 (2) in subsection (c)(3)—

17 (A) in subparagraph (A), by striking

18 ‘‘clause (i) or (ii) of subsection (b)(2)(A)’’ and

19 inserting ‘‘subparagraph (A) or (B) of sub20 section (b)(2)’’;

21 (B) in subparagraph (B), by striking

22 ‘‘clause (iii) of subsection (b)(2)(A)’’ and all

23 that follows through the period and inserting

24 ‘‘subparagraph (C) of subsection (b)(2), the ap-
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1 proval may be made effective on the date cer2 tified under subparagraph (C).’’;

3 (C) in subparagraph (C), by striking

4 ‘‘clause (iv) of subsection (b)(2)(A)’’ and insert5 ing ‘‘subparagraph (D) of subsection (b)(2)’’;

6 and

7 (D) in subparagraph (D)(ii), by striking

8 ‘‘clause (iv) of subsection (b)(2)(A)’’ and insert9 ing ‘‘subparagraph (D) of subsection (b)(2)’’;

10 and

11 (3) in subsection (j), in paragraph (2)(A), in

12 the matter following clause (vii)(IV), by striking

13 ‘‘clauses (i) through (viii)’’ and inserting ‘‘clauses (i)

14 through (vii)’’.

15 (b) PEDIATRIC STUDIES OF DRUGS.—Section 505A

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

17 355a) is amended—

18 (1) in subsection (a)(2)—

19 (A) in clause (i) of subparagraph (A), by

20 striking ‘‘(b)(2)(A)(ii)’’ and inserting ‘‘(b)(2)’’;

21 (B) in clause (ii) of subparagraph (A), by

22 striking ‘‘(b)(2)(A)(iii)’’ and inserting ‘‘(b)(2)’’;

23 and
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1 (C) in subparagraph (B), by striking ‘‘sub2 section (b)(2)(A)(iv)’’ and inserting ‘‘subsection

3 (b)(2)’’; and

4 (2) in subsection (c)(2)—

5 (A) in clause (i) of subparagraph (A), by

6 striking ‘‘(b)(2)(A)(ii)’’ and inserting ‘‘(b)(2)’’;

7 (B) in clause (ii) of subparagraph (A), by

8 striking ‘‘(b)(2)(A)(iii)’’ and inserting ‘‘(b)(2)’’;

9 and

10 (C) in subparagraph (B), by striking ‘‘sub11 section (b)(2)(A)(iv)’’ and inserting ‘‘subsection

12 (b)(2)’’.

13 (c) DEFINITION.—Section 201 of the Federal Food,

14 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by

15 adding at the end the following:

16 ‘‘(kk) For purposes of the references to court deci17 sions in clauses (i) and (iii) of section 505(c)(3)(C) and

18 clauses (iii)(I), (iii)(III) of section 505(j)(5)(B), the term

19 ‘the court’ means the court that enters final judgment

20 from which no appeal (not including a writ of certiorari)

21 can or has been taken.’’.

Æ