[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2300 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 2300

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
     market exclusivity for certain drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 16, 2006

Ms. Stabenow (for herself and Mr. Lott) 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 with respect to 
     market exclusivity for certain drugs, and for other purposes.

    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 ``Lower Prices Reduced with Increased 
Competition and Efficient Development of Drugs Act'' or the ``Lower 
PRICED Drugs Act''.

SEC. 2. GENERIC DRUG USE CERTIFICATION.

    (a) In General.--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 (vii), by striking ``; and'' and inserting a 
        semicolon;
            (2) in clause (viii), by striking the period and inserting 
        ``; and'';
            (3) by inserting after clause (viii) the following:
            ``(ix) if with respect to a listed drug product referred to 
        in clause (i) that contains an antibiotic drug and the 
        antibiotic drug was the subject of any application for 
        marketing received by the Secretary under section 507 (as in 
        effect before the date of enactment of the Food and Drug 
        Administration Modernization Act of 1997) before November 20, 
        1997, the approved labeling includes a method of use which, in 
        the opinion of the applicant, is claimed by any patent, a 
        statement that--
                    ``(I) identifies the relevant patent and the 
                approved use covered by the patent; and
                    ``(II) the applicant is not seeking approval of 
                such use under this subsection.''; and
            (4) in the last sentence, by striking ``clauses (i) through 
        (viii)'' and inserting ``clauses (i) through (ix)''.
    (b) Effective Date.--The amendments made by this section shall 
apply to any abbreviated new drug application under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is 
submitted on, before, or after the date of enactment of this Act.

SEC. 3. PREVENTING ABUSE OF THE THIRTY-MONTH STAY-OF-EFFECTIVENESS 
              PERIOD.

    (a) In General.--Section 505(j)(5)(B)(iii) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) is amended--
            (1) in the second sentence by striking ``may order'' and 
        inserting ``shall order''; and
            (2) by adding at the end the following: ``In determining 
        whether to shorten the thirty-month period under this clause, 
        the court shall consider the totality of the circumstances, 
        including whether the plaintiff sought to extend the discovery 
        schedule, delayed producing discovery, or otherwise acted in a 
        dilatory manner, and the public interest.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to any stay of effectiveness period under section 
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(B)(iii)) pending or filed on or after the date of 
enactment of this Act.

SEC. 4. ENSURING PROPER USE OF PEDIATRIC EXCLUSIVITY.

    (a) Drug Product.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended by striking ``drug'' each 
place it appears and inserting ``drug product''.
    (b) Market Exclusivity for New Drugs.--Section 505A(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(b)) is amended--
            (1) in the matter preceding paragraph (1), by--
                    (A) striking ``health'' and inserting 
                ``therapeutically meaningful'';
                    (B) striking ``and'' after ``(which shall include a 
                timeframe for completing such studies),''; and
                    (C) inserting ``, and based on the results of such 
                studies the Secretary approves labeling for the new 
                drug product that provides specific, therapeutically 
                meaningful information about the use of the drug 
                product in pediatric patients'' after ``in accordance 
                with subsection (d)(3)'';
            (2) in paragraph (1)(A)--
                    (A) in clause (i), by--
                            (i) striking ``the period'' and inserting 
                        ``any period''; and
                            (ii) inserting ``that is applicable to the 
                        drug product at the time of initial approval'' 
                        after ``in subsection (j)(5)(F)(ii) of such 
                        section''; and
                    (B) in clause (ii), by--
                            (i) striking ``the period'' and inserting 
                        ``any period''; and
                            (ii) inserting ``that is applicable to the 
                        drug product at the time of initial approval'' 
                        after ``of subsection (j)(5)(F) of such 
                        section''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``a listed 
                        patent'' and inserting ``a patent that was 
                        either listed when the pediatric study was 
                        submitted to the Food and Drug Administration 
                        or listed as a result of the approval by the 
                        Food and Drug Administration of new pediatric 
                        labeling that is claimed by the patent, and''; 
                        and
                            (ii) in clause (ii) by striking ``a listed 
                        patent'' and inserting ``a patent that was 
                        either listed when the pediatric study was 
                        submitted to the Food and Drug Administration 
                        or listed as a result of the approval by the 
                        Food and Drug Administration of new pediatric 
                        labeling that is claimed by the patent, and''; 
                        and
                    (B) in subparagraph (B), by striking ``a listed 
                patent'' and inserting ``a patent that was either 
                listed when the pediatric study was submitted to the 
                Food and Drug Administration or listed as a result of 
                the approval by the Food and Drug Administration of new 
                pediatric labeling that is claimed by the patent, 
                and''.
    (c) Market Exclusivity for Already-Marketed Drugs.--Section 505A(c) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(c)) is 
amended--
            (1) in the matter preceding paragraph (1), by--
                    (A) striking ``health'' and inserting 
                ``therapeutically meaningful'';
                    (B) striking ``and'' after ``the studies are 
                completed within any such timeframe,''; and
                    (C) inserting ``, and based on the results of such 
                studies the Secretary approves labeling for the 
                approved drug product that provides specific, 
                therapeutically meaningful information about the use of 
                the drug product in pediatric patients'' after ``in 
                accordance with subsection (d)(3)'';
            (2) in paragraph (1)(A)--
                    (A) in clause (i)--
                            (i) by striking ``the period'' and 
                        inserting ``any period''; and
                            (ii) by inserting ``that is applicable to 
                        the drug product at the time of initial 
                        approval'' after ``in subsection (j)(5)(F)(ii) 
                        of such section''; and
                    (B) in clause (ii)--
                            (i) by striking ``the period'' and 
                        inserting ``any period''; and
                            (ii) by inserting ``that is applicable to 
                        the drug product at the time of initial 
                        approval'' after ``of subsection (j)(5)(F) of 
                        such section''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``a listed 
                        patent'' and inserting ``a patent that was 
                        either listed when the pediatric study was 
                        submitted to the Food and Drug Administration 
                        or listed as a result of the approval by the 
                        Food and Drug Administration of new pediatric 
                        labeling that is claimed by the patent, and''; 
                        and
                            (ii) in clause (ii), by striking ``a listed 
                        patent'' and inserting ``a patent that was 
                        either listed when the pediatric study was 
                        submitted to the Food and Drug Administration 
                        or listed as a result of the approval by the 
                        Food and Drug Administration of new pediatric 
                        labeling that is claimed by the patent, and''; 
                        and
                    (B) in subparagraph (B), by striking ``a listed 
                patent'' and by inserting ``a patent that was either 
                listed when the pediatric study was submitted to the 
                Food and Drug Administration or listed as a result of 
                the approval by the Food and Drug Administration of new 
                pediatric labeling that is claimed by the patent, 
                and''.
    (d) Three-Month Exclusivity.--Section 505A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by--
            (1) by striking ``six months'' each place it appears and 
        inserting ``three months'';
            (2) by striking ``six-month'' each place it appears and 
        inserting ``three-month'';
            (3) by striking ``6-month'' each place it appears and 
        inserting ``three-month'';
            (4) in subsection (b)(1)(A)(i), by striking ``four and one-
        half years, fifty-four months, and eight years, respectively'' 
        and inserting ``four years and three months, fifty-one months, 
        and seven years and nine months, respectively''; and
            (5) in subsection (c)(1)(A)(i), by striking ``four and one-
        half years, fifty-four months, and eight years, respectively'' 
        and inserting ``four years and three months, fifty-one months, 
        and seven years and nine months, respectively''.
    (e) Definition.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended by adding at the end the 
following:
    ``(o) Drug Product.--
            ``(1) In general.--For purposes of this section, the term 
        `drug product' has the same meaning given such term in section 
        314.3(b) of title 21, Code of Federal Regulations (or any 
        successor regulation).
            ``(2) Separate drug products.--For purposes of this 
        section, each dosage form of a drug product shall constitute a 
        different drug product.''.
    (f) Technical Corrections.--Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) by striking ``subsection (c)(3)(D)'' each place it 
        appears and inserting ``subsection (c)(3)(E)''; and
            (2) in subsection (n), by striking ``under subsection (a) 
        or (c)'' and inserting ``under subsection (b) or (c)''.
    (g) Effective Date.--The amendments made by this section shall 
apply to requests by the Secretary of Health and Human Services for 
pediatric studies under section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) after the date of enactment of this Act.

SEC. 5. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(o) Citizens Petitions and Petitions for Stay of Agency Action.--
With respect to any petition that seeks to have the Secretary take, or 
refrain from taking, any form of action relating to the approval of an 
application submitted under subsection (b)(2) or (j), the following 
shall apply:
            ``(1) No delay of approval.--The Secretary shall not delay 
        approval of an application submitted under subsection (b)(2) or 
        (j) while a petition is reviewed and considered. Consideration 
        of a petition shall be separate and apart from the review and 
        approval of an application submitted under either such 
        subsection.
            ``(2) Timing of final agency action.--The Secretary shall 
        take final agency action with respect to a petition within six 
        months of receipt of that petition. The Secretary shall not 
        extend such six-month review period, even with consent of the 
        petitioner, for any reason, including based upon the submission 
        of comments relating to a petition or supplemental information 
        supplied by the petitioner. If the Secretary has not taken 
        final agency action on a petition by the date that is six 
        months after the date of receipt of the petition, such petition 
        shall be deemed to have been denied on such date.
            ``(3) Verification.--The Secretary shall not accept for 
        review a petition unless it is signed and contains the 
        following verification: `I certify that, to my best knowledge 
        and belief: (a) this petition includes all information and 
        views upon which the petition relies; (b) this petition 
        includes representative data and/or information known to the 
        petitioner which are unfavorable to the petition; and (c) I 
        have taken reasonable steps to ensure that any representative 
        data and/or information which are unfavorable to the petition 
        were disclosed to me. I further certify that the information 
        upon which I have based the action requested herein first 
        became known to the party on whose behalf this petition is 
        filed on or about __________. I verify under penalty of perjury 
        that the foregoing is true and correct.', with the date of the 
        filing of such petition inserted in the blank space.
            ``(4) Extension of period.--The thirty-month period 
        referred to in subsection (j)(5)(D)(i)(IV) shall automatically 
        be extended by the amount of time that lapses from the date 
        that the Secretary receives a petition and the date of final 
        agency action on that petition, without regard to whether the 
        Secretary grants, in whole or in part, or denies, in whole or 
        in part, that petition.''.
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