[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5247 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 5247

 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 21, 2000

  Mr. Baldacci (for himself and Mr. Coburn) introduced the following 
         bill; which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.

    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.''.
                                 <all>