[Congressional Record Volume 146, Number 108 (Thursday, September 14, 2000)]
[Senate]
[Pages S8589-S8590]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SCHUMER (for himself, Mr. McCain, and Mr. Johnson):
  S. 3051. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; to the Committee 
on Health, Education, Labor, and Pensions.

[[Page S8590]]

            greater access to affordable pharmaceuticals act

  Mr. McCAIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 3051

       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 ``Greater Access to Affordable 
     Pharmaceuticals Act'' or the ``GAAP Act of 2000''.

     SEC. 2. NEW DRUG APPLICATIONS.

       (a) Limitations on the Use of Patents to Prevent Approval 
     of Abbreviated New Drug Applications.--Section 505(b)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(b)(2)) is amended--
       (1) in subparagraph (A)--
       (A) in the matter preceding clause (i), by striking ``the 
     drug for which such investigations were conducted or which 
     claims a use for such drug for which the applicant is seeking 
     approval under this subsection'' and inserting ``an active 
     ingredient of the drug for which such investigations were 
     conducted, alone or in combination with another active 
     ingredient or which claims the first approved use for such 
     drug for which the applicant is seeking approval under this 
     subsection''; and
       (B) in clause (iv), by striking ``; and'' and inserting a 
     period;
       (2) in the matter preceding subparagraph (A), by striking 
     ``shall also include--'' and all that follows through ``a 
     certification'' and inserting ``shall also include a 
     certification'';
       (3) by striking subparagraph (B); and
       (4) by redesignating clauses (i) through (iv) as 
     subparagraphs (A) through (D), respectively, and aligning the 
     margins of the subparagraphs with the margins of subparagraph 
     (A) of section 505(c)(1) of that Act (21 U.S.C. 355(c)(1)).
       (b) Abbreviated New Drug Applications.--Section 
     505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(j)(2)(A)) is amended--
       (1) in clause (vi), by striking the semicolon and inserting 
     ``; and''; and
       (2) in clause (vii)--
       (A) in the matter preceding subclause (I), by striking 
     ``the listed drug referred to in clause (i) or which claims a 
     use for such listed drug for which the applicant is seeking 
     approval under this subsection'' and inserting ``an active 
     ingredient of the listed drug referred to in clause (i), 
     alone or in combination with another active ingredient or 
     which claims the first approved use for such drug for which 
     the applicant is seeking approval under this subsection'';
       (B) in subclause (IV), by striking ``; and'' and inserting 
     a period; and
       (C) by striking clause (viii).
       (c) Effective Date.--The amendments made by this section 
     shall only be effective with respect to a listed drug for 
     which no certification pursuant to section 
     505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, Cosmetic Act 
     was made prior to the date of enactment of this Act.

     SEC. 3. CITIZEN PETITION REVIEW.

       Section 505(j)(5) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(5)) is amended--
       (1) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (D) and (E), respectively; and
       (2) by inserting after subparagraph (B) the following:
       ``(C) Notwithstanding any other provision of law, the 
     submission of a citizen's petition filed pursuant to section 
     10.30 of title 21, Code of Federal Regulations, with respect 
     to an application submitted under paragraph (2)(A), shall not 
     cause the Secretary to delay review and approval of such 
     application, unless such petition demonstrates through 
     substantial scientific proof that approval of such 
     application would pose a threat to public health and 
     safety.''.

     SEC. 4. BIOEQUIVALENCE TESTING METHODS.

       Section 505(j)(8)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(8)(B)) is amended--
       (1) in clause (i), by striking ``or'' at the end;
       (2) in clause (ii), by striking the period and inserting 
     ``; or''; and
       (3) by adding at the end the following:
       ``(iii) the effects of the drug and the listed drug do not 
     show a significant difference based on tests (other than 
     tests that assess rate and extent of absorption), including 
     comparative pharmacodynamic studies, limited confirmation 
     studies, or in vitro methods, that demonstrate that no 
     significant differences in therapeutic effects of active or 
     inactive ingredients are expected.''.

     SEC. 5. ACCELERATED GENERIC DRUG COMPETITION.

       (a) In General.--Section 505(j)(5) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
       (1) in subparagraph (B)(iv), by striking subclause (II) and 
     inserting the following:
       ``(II) the date of a final decision of a court in an action 
     described in clause (ii) from which no appeal can or has been 
     taken, or the date of a settlement order or consent decree 
     signed by a Federal judge, that enters a final judgement, and 
     includes a finding that the relevant patents that are the 
     subject of the certification involved are invalid or not 
     infringed, whichever is earlier,'';
       (2) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (D) and (E), respectively; and
       (3) by inserting after subparagraph (B), the following:
       ``(C) The one-hundred and eighty day period described in 
     subparagraph (B)(iv) shall become available to the next 
     applicant submitting an application containing a 
     certification described in paragraph (2)(A)(vii)(IV) if the 
     previous applicant fails to commence commercial marketing of 
     its drug product once its application is made effective, 
     withdraws its application, or amends the certification from a 
     certification under subclause (IV) to a certification under 
     subclause (III) of such paragraph, either voluntarily or as a 
     result of a settlement or defeat in patent litigation.''.
       (b) Effective Date.--The amendments made by this section 
     shall only be effective with respect to an application filed 
     under section 505(j) of the Federal Food, Drug, Cosmetic Act 
     for a listed drug for which no certification pursuant to 
     505(j)(2)(A)(vii)(IV) of such Act was made prior to the date 
     of enactment of this Act.

     SEC. 6. SENSE OF CONGRESS.

       It is the sense of Congress that measures should be taken 
     to effectuate the purpose of the Drug Price Competition and 
     Patent Term Restoration Act of 1984 (referred to in this 
     section as the ``Hatch-Waxman Act'') to make generic drugs 
     more available and accessible, and thereby reduce health care 
     costs, including measures that require manufacturers of a 
     drug for which an application is approved under section 
     505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     255(c)) desiring to extend a patent of such drug to utilize 
     the patent extension procedure provided under the Hatch-
     Waxman Act.

     SEC. 7. CONFORMING AMENDMENTS.

       (a) Applications.--Section 505 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355) is amended--
       (1) in subsection (b)(3), in subparagraphs (A) and (C), by 
     striking ``paragraph (2)(A)(iv)'' and inserting ``paragraph 
     (2)'';
       (2) in subsection (c)(3)--
       (A) in subparagraph (A), by striking ``clause (i) or (ii) 
     of subsection (b)(2)(A)'' and inserting ``subparagraph (A) or 
     (B) of subsection (b)(2)'';
       (B) in subparagraph (B), by striking ``clause (iii) of 
     subsection (b)(2)(A)'' and all that follows through the 
     period and inserting ``subparagraph (C) of subsection (b)(2), 
     the approval may be made effective on the date certified 
     under subparagraph (C).'';
       (C) in subparagraph (C), by striking ``clause (iv) of 
     subsection (b)(2)(A)'' and inserting ``subparagraph (D) of 
     subsection (b)(2)''; and
       (D) in subparagraph (D)(ii), by striking ``clause (iv) of 
     subsection (b)(2)(A)'' and inserting ``subparagraph (D) of 
     subsection (b)(2)''; and
       (3) in subsection (j), in paragraph (2)(A), in the matter 
     following clause (vii)(IV), by striking ``clauses (i) through 
     (viii)'' and inserting ``clauses (i) through (vii)''.
       (b) Pediatric Studies of Drugs.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended--
       (1) in subsection (a)(2)--
       (A) in clause (i) of subparagraph (A), by striking 
     ``(b)(2)(A)(ii)'' and inserting ``(b)(2)'';
       (B) in clause (ii) of subparagraph (A), by striking 
     ``(b)(2)(A)(iii)'' and inserting ``(b)(2)''; and
       (C) in subparagraph (B), by striking ``subsection 
     (b)(2)(A)(iv)'' and inserting ``subsection (b)(2)''; and
       (2) in subsection (c)(2)--
       (A) in clause (i) of subparagraph (A), by striking 
     ``(b)(2)(A)(ii)'' and inserting ``(b)(2)'';
       (B) in clause (ii) of subparagraph (A), by striking 
     ``(b)(2)(A)(iii)'' and inserting ``(b)(2)''; and
       (C) in subparagraph (B), by striking ``subsection 
     (b)(2)(A)(iv)'' and inserting ``subsection (b)(2)''.
       (c) Definition.--Section 201 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321) is amended by adding at the end 
     the following:
       ``(kk) For purposes of the references to court decisions in 
     clauses (i) and (iii) of section 505(c)(3)(C) and clauses 
     (iii)(I), (iii)(III) of section 505(j)(5)(B), the term `the 
     court' means the court that enters final judgment from which 
     no appeal (not including a writ of certiorari) can or has 
     been taken.''.
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