[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6022 Introduced in House (IH)]








109th CONGRESS
  2d Session
                                H. R. 6022

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2006

 Mr. Waxman (for himself, Mr. Pallone, and Ms. DeLauro) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 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 the 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 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 the 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 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 the 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 or drug 
                product 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), a patent concerning a drug 
        is a qualifying listed patent for purposes of this subsection 
        if the patent meets the condition described in subparagraph 
        (A), or the condition described in subparagraph (B), as 
        follows:
                    ``(A) Information on the patent had been 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).
                    ``(B) After such date, the patent became subject to 
                the requirement under such subsection to file 
                information on the patent as a result of the approval 
                by the Secretary of a use of the drug in the pediatric 
                population, which use--
                            ``(i) is described in the approved labeling 
                        referred to in paragraph (1)(D); and
                            ``(ii) is claimed by the patent.
    ``(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 one of the conditions described in 
        subparagraph (A) or (B) of subsection (b)(3), as applied to the 
        drug referred to in paragraph (1).''.
    (b) Determination 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) One month, if the sales revenue for the drug 
                that is projected under paragraph (3) for the base year 
                is $1,000,000,000 or more.
                    ``(B) Two months, if the sales revenue for the drug 
                that is so projected is $500,000,000 or more but less 
                than $1,000,000,000.
                    ``(C) Three months, if the sales revenue for the 
                drug that is so projected is less than $500,000,000.
            ``(2) Base year.--For purposes of this subsection, the base 
        year for a drug is the calendar year during 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 two-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 three 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 the enactment of this 
        Act.
            (2) Effective date.--The amendments made by this subsection 
        take effect 180 days after the date of the 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) of this section, is amended--
            (1) in subsection (e)(4)(C), by inserting ``of the Public 
        Health Service Act'' after ``499(j)(9)(B)(i)''; and
            (2) in each of subsections (f) and (g), by striking 
        ``subsection (d)'' each place such term appears and inserting 
        ``subsection (e)''; and
            (3) in subsection (n), by striking ``under subsection (a) 
        or (c)'' and inserting ``under subsection (b) or (c)''.
    (e) Effective Date.--The amendments made by this section 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 the 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) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
            ``(1) In general.--With respect to a pending application 
        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 applies, subject to paragraph (5):
                    ``(A)(i) In the case of an application under 
                subsection (b)(2), the Secretary may not, subject to 
                clause (iii), consider the petition if it is submitted 
                later than 210 days prior to the date on which the 
                approval of the application may first be made effective 
                under subsection (c)(3), including subparagraphs (C) 
                and (E) (as applicable), or 210 days prior to the 
                expiration of any 30-month stay under such subparagraph 
                (C) with respect to the application, whichever is 
                later.
                    ``(ii) In the case of an application under 
                subsection (j), the Secretary may not, subject to 
                clause (iii), consider the petition if it is submitted 
                later than 210 days prior to the date on which the 
                approval of the application may first be made effective 
                under paragraph (5) of such subsection, including 
                subparagraphs (B)(iii) and (F) (as applicable), or 210 
                days prior to the expiration of any 30-month stay under 
                such subparagraph (B)(iii) with respect to the 
                application, whichever is later.
                    ``(iii) The restriction established in clause (i) 
                or (ii) (as the case may be) does not apply to the 
                petition if the Secretary determines that the 
                petitioner has shown good cause for the failure to 
                submit the petition by the applicable date under such 
                clause.
                    ``(B)(i) The Secretary may not, on the basis of the 
                petition, delay approval of the application unless the 
                Secretary determines that a delay is necessary to 
                protect the public health. Consideration of a petition 
                shall be separate and apart from the review and 
                approval of the application.
                    ``(ii) With respect to a determination by the 
                Secretary under clause (i) that a delay is necessary to 
                protect the public health:
                            ``(I) The Secretary shall publish on the 
                        Internet site of the Food and Drug 
                        Administration a statement providing the 
                        reasons underlying the determination.
                            ``(II) Not later than 10 days after making 
                        the determination, the Secretary shall provide 
                        notice to the sponsor of the application and an 
                        opportunity for a meeting with the Commissioner 
                        to discuss the determination.
                    ``(C) The Secretary shall take final agency action 
                on the petition not later than 180 days after the date 
                on which the petition is submitted. The Secretary shall 
                not extend such period, even with the consent of the 
                petitioner, for any reason, including based upon the 
                submission of comments relating to the petition or 
                supplemental information supplied by the petitioner.
                    ``(D) If the filing of the application resulted in 
                first-applicant status under subsection 
                (j)(5)(D)(i)(IV), the 30-month period under such 
                subsection is deemed to be extended by a period of time 
                equal to the period beginning on the date on which the 
                Secretary received the petition and ending on the date 
                of final agency action on the petition (inclusive of 
                such beginning and ending dates), without regard to 
                whether the Secretary grants, in whole or in part, or 
                denies, in whole or in part, the petition.
                    ``(E) The Secretary may not consider the petition 
                for review 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 submitted on or about the 
                following date: __________. 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.'.
            ``(2) Exhaustion of administrative remedies.--
                    ``(A) Final agency action within 180 days .--The 
                Secretary shall be considered to have taken final 
                agency action on a petition referred to in paragraph 
                (1) if--
                            ``(i) during the 180-day period referred to 
                        in subparagraph (C) of such paragraph, the 
                        Secretary makes a final decision within the 
                        meaning of section 10.45(d) of title 21, Code 
                        of Federal Regulations; 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 paragraph (1) before final agency action 
                within the meaning of subparagraph (A) has occurred, 
                the court shall dismiss the action for failure to 
                exhaust administrative remedies.
            ``(3) Applicability of certain regulations.--The provisions 
        of this section are in addition to the requirements for the 
        submission of a petition to the Secretary that apply under 
        section 10.30 or 10.35 of title 21, Code of Federal 
        Regulations.
            ``(4) Annual report on delays in approvals per petitions.--
        The Secretary shall annually submit to the 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 such applications whose 
                effective dates were delayed by petitions referred to 
                in paragraph (1) during such period; and
                    ``(C) the number of days by which the applications 
                were so delayed.
            ``(5) Exceptions.--This subsection does not apply to--
                    ``(A) a petition that relates solely to the timing 
                of the approval of an application pursuant to 
                subsection (j)(5)(B)(iv); or
                    ``(B) a petition that is made by the sponsor of an 
                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.
            ``(6) 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>