[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1088 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1088

   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

                             April 11, 2007

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) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended by striking subsections (b) 
and (c) and inserting the following:
    ``(b) Market Exclusivity for New Drugs.--
            ``(1) In general.--With respect to a pending application 
        under section 505(b)(1), each of the periods of time under this 
        chapter specified in paragraph (2) that is applicable with 
        respect to the drug involved is deemed to be extended by the 
        period of time determined under subsection (d) if, prior to 
        approval of such application--
                    ``(A) the Secretary determines that information 
                relating to the use in the pediatric population of the 
                drug may produce health benefits in that population;
                    ``(B) the Secretary makes a written request to the 
                sponsor of the application for one or more pediatric 
                studies, which request shall include a timeframe for 
                completing such studies;
                    ``(C) the sponsor agrees to the request;
                    ``(D) such studies are completed within any such 
                timeframe and the reports thereof submitted in 
                accordance with subsection (e)(2) or accepted in 
                accordance with subsection (e)(3); and
                    ``(E) based on the results of such studies, the 
                Secretary approves labeling for the drug that provides 
                specific, therapeutically meaningful information about 
                the use of the drug in pediatric patients.
            ``(2) Period of time to be extended.--For purposes of 
        paragraph (1), the periods of time under this chapter that are 
        specified in this paragraph with respect to the drug involved 
        are the following:
                    ``(A) In section 505:
                            ``(i) In each of subsections (c)(3)(E)(ii) 
                        and (j)(5)(F)(ii):
                                    ``(I) The period of five years.
                                    ``(II) The period of four years, 
                                the period of forty-eight months, and 
                                the period of seven and one-half years.
                            ``(ii) In each of clauses (iii) and (iv) of 
                        subsection (c)(3)(E), and in each of clauses 
                        (iii) and (iv) of subsection (j)(5)(F), the 
                        period of three years.
                    ``(B) In section 527(a), the period of seven years, 
                in the case of a drug designated under section 526 for 
                a rare disease or condition.
                    ``(C) In section 505, under subsections (c)(3) and 
                (j)(5)(B), the period of time during which the approval 
                of an application may not be made effective, in the 
                case of a drug that--
                            ``(i) is the subject of a qualifying listed 
                        patent for which a certification has been 
                        submitted under subsection (b)(2)(A)(ii) or 
                        (j)(2)(A)(vii)(II) of such section and for 
                        which pediatric studies were submitted prior to 
                        the expiration of the patent (including any 
                        patent extensions);
                            ``(ii) is the subject of a qualifying 
                        listed patent for which a certification has 
                        been submitted under subsections (b)(2)(A)(iii) 
                        or (j)(2)(A)(vii)(III) of such section; or
                            ``(iii) is the subject of a qualifying 
                        listed patent for which a certification has 
                        been submitted under subsection (b)(2)(A)(iv) 
                        or (j)(2)(A)(vii)(IV) of such section, and with 
                        respect to which, in the patent infringement 
                        litigation resulting from the certification, 
                        the court determines that the patent is valid 
                        and would be infringed.
        With respect to subparagraph (C), the extension of time that 
        applies under this subsection begins on the day after the date 
        of the expiration of the patent involved (including any patent 
        extension).
            ``(3) Qualifying listed patent.--With respect to a study 
        submitted pursuant to paragraph (1), information on the patent 
        must be filed with the Secretary as required under subsection 
        (b)(1) or (c)(2) of section 505 as of the date on which the 
        study was submitted to the Secretary pursuant to paragraph (1) 
        in order to be considered a qualifying listed patent for 
        purposes of this subsection.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--
            ``(1) In general.--With respect to an approved application 
        under section 505(b)(1), each of the periods of time under this 
        chapter specified in paragraph (2) that is applicable with 
        respect to the drug involved is deemed to be extended by the 
        period of time determined under subsection (d) if--
                    ``(A) the Secretary determines that information 
                relating to the use in the pediatric population of the 
                drug may produce health benefits in that population;
                    ``(B) the Secretary makes a written request to the 
                holder of such application for one or more pediatric 
                studies, which request shall include a timeframe for 
                completing such studies;
                    ``(C) the holder agrees to the request;
                    ``(D) such studies are completed within any such 
                timeframe and the reports thereof submitted in 
                accordance with subsection (e)(2) or accepted in 
                accordance with subsection (e)(3); and
                    ``(E) based on the results of such studies, the 
                Secretary approves labeling for the drug that provides 
                specific, therapeutically meaningful information about 
                the use of the drug in pediatric patients.
            ``(2) Period of time to be extended.--For purposes of 
        paragraph (1), the periods of time under this chapter that are 
        specified in this paragraph are the periods of time referred to 
        in subsection (b)(2), as applied to the drug referred to in 
        paragraph (1). With respect to periods of time referred to in 
        subsection (b)(2)(C) as applied to such drug, the extension of 
        time that applies under this subsection begins on the day after 
        the date of the expiration of the patent involved (including 
        any patent extension).
            ``(3) Qualifying listed patent.--With respect to a study 
        submitted pursuant to paragraph (1), a patent concerning a drug 
        is a qualifying listed patent for purposes of this subsection 
        if the patent meets the condition described in subsection 
        (b)(3), as applied to the drug referred to in paragraph (1).''.
    (b) Length of Extension Period.--Section 505A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) by redesignating subsections (d) through (n) as 
        subsections (e) through (o), respectively; and
            (2) by inserting after subsection (c) the following:
    ``(d) Determination of Extension Period.--
            ``(1) In general.--For purposes of subsections (b) and (c), 
        the extension period determined under this subsection with 
        respect to a drug is the following, as applicable:
                    ``(A) 3 months, if the sales revenue for the same 
                active moiety that is projected under paragraph (3) for 
                the base year is $1,000,000,000 or more.
                    ``(B) 6 months, if the sales revenue for the same 
                active moiety that is projected under paragraph (3) for 
                the base year is less than $1,000,000,000.
            ``(2) Base year.--For purposes of this subsection, the base 
        year for the same active moiety is the preceding 12 months from 
        the date which market exclusivity under Federal law for the 
        drug would expire in the absence of an extension under 
        subsection (b) or (c).
            ``(3) Projection of sales revenue.--
                    ``(A) In general.--For purposes of paragraph (1), 
                the Secretary shall make an estimate of the sales 
                revenue for a drug for a base year on the basis of the 
                sales histories of an appropriate sample of drugs over 
                the 20-year period preceding the date of the enactment 
                of the Lower PRICED Drugs Act, including data on the 
                sales revenue of the drug that has been included in 
                reports by IMS Health.
                    ``(B) Timing of projection.--An estimate under 
                subparagraph (A) for a drug shall be a projection made 
                in advance of the base year for the drug. In the case 
                of an extension period under subsection (b), the 
                projection may not be made earlier than the expiration 
                of the 2-year period beginning on the date on which the 
                drug is approved by the Secretary under section 505, 
                unless all market exclusivity under Federal law for the 
                drug will, in the absence of an extension under 
                subsection (b), expire before the expiration of such 
                period, in which case the projection shall be 
                determined not later than 3 months before the beginning 
                of the base year.
                    ``(C) IMS health.--The reference in subparagraph 
                (A)(ii) to IMS Health is a reference to the corporation 
                Intercontinental Marketing Services, first established 
                in 1954, whose activities include the conduct of 
                syndicated market research studies of the 
                pharmaceutical industry and the international 
                monitoring of prescription drug sales.
            ``(4) Criteria.--The Secretary shall by regulation 
        establish criteria for making projections under paragraph 
        (1).''.
    (c) Final Rule for Criteria for Projection of Sales Revenue; 
Effective Date.--
            (1) Final rule.--With respect to criteria under subsection 
        (d)(4) of section 505A of the Federal Food, Drug, and Cosmetic 
        Act, as added by subsection (b) of this section, the Secretary 
        of Health and Human Services shall promulgate the final rule 
        not later than 180 days after the date of enactment of this 
        Act.
            (2) Effective date.--The amendments made by this subsection 
        take effect 180 days after the date of enactment of this Act, 
        without regard to whether the final rule under paragraph (1) 
        has been promulgated, subject to subsection (e). The preceding 
        sentence does not affect the requirement under paragraph (1) 
        for the Secretary to promulgate a final rule, notwithstanding 
        circumstances under the preceding sentence in which such 
        amendments have taken effect in the absence of a final rule.
    (d) Conforming Amendments; Technical Corrections.--Section 505A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as amended 
by subsection (b)(1), is amended--
            (1) in subsection (e)(4)(C), by inserting ``of the Public 
        Health Service Act'' after ``499(j)(9)(B)(i)'';
            (2) in subsection (f), by striking ``subsection (c)(3)(D)'' 
        each place it appears and inserting ``subsection (c)(3)(E)'';
            (3) in each of subsections (f) and (g), by striking 
        ``subsection (d)'' each place such term appears and inserting 
        ``subsection (e)''; and
            (4) in subsection (o), by striking ``under subsection (a) 
        or (c)'' and inserting ``under subsection (b) or (c)''.
    (e) 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 a pending application submitted under subsection (b)(2) 
or (j), if a petition is submitted to the Secretary that seeks to have 
the Secretary take, or refrain from taking, any form of action relating 
to the approval of the application, including a delay in the effective 
date of the application, 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 180 
        days of submission of that petition. The Secretary shall not 
        extend such 180-day 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 180 days 
        after the date of submission 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 received or expect to receive 
        payments, including cash and other forms of consideration, from 
        the following persons or organizations to file this petition: 
        __________. I verify under penalty of perjury that the 
        foregoing is true and correct.', with the date of the filing of 
        such petition being inserted in the first blank space, and the 
        appropriate names of persons or organizations being inserted in 
        the second 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.
            ``(5) Exhaustion of administrative remedies.--
                    ``(A) Final agency action within 180 days.--The 
                Secretary shall be considered to have take final agency 
                action on a petition referred to in this subsection 
                if--
                            ``(i) during the 180-day period referred to 
                        in paragraph (2), the Secretary makes a final 
                        decision within the meaning of section 10.45(d) 
                        of title 21, Code of Federal Regulations (or 
                        any successor regulation); or
                            ``(ii) such period expires without the 
                        Secretary having made such a final decision.
                    ``(B) Dismissal of certain civil actions.--If a 
                civil action is filed with respect to a petition 
                referred to in this subsection before final agency 
                action, the court shall dismiss the action for failure 
                to exhaust administrative remedies.
            ``(6) Annual report on delays in approvals per petition.--
        The Secretary shall annually submit to Congress a report that 
        specifies--
                    ``(A) the number of applications under subsections 
                (b)(2) and (j) that were approved during the preceding 
                12-month period;
                    ``(B) the number of petitions described in this 
                subsection that were submitted during such period;
                    ``(C) the number of such applications whose 
                effective dates were delayed by such petitions during 
                such period; and
                    ``(D) the number of days by which the applications 
                were so delayed.
            ``(7) Exception.--This subsection does not apply to a 
        petition that is made by the sponsor of the application under 
        subsection (b)(2) or (j) and that seeks only to have the 
        Secretary take or refrain from taking any form of action with 
        respect to that application.
            ``(8) Definition.--For purposes of this subsection, the 
        term `petition' includes any request to the Secretary, without 
        regard to whether the request is characterized as a 
        petition.''.
                                 <all>