text: 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.''.
target: States that the filing of a citizen petition review shall not cause the Secretary of Health and Human Services to delay review and approval of an abbreviated  new drug application unless the petition demonstrates through substantial scientific proof that approval would pose a threat to public health and safety.
  Allows a drug to be considered a bioequivalent to a listed drug if the effects of such drug and the listed drug do not show a significant difference based on certain tests or studies.
  Provides for an accelerated date of approval of a generic drug application.
  Expresses 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 to make generic drugs more available and accessible, thereby reducing health care costs.
feat_title: GAAP Act of 2000