[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2589 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 2589

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
   Service Act to reauthorize and amend the Best Pharmaceuticals for 
          Children Act and the Pediatric Research Equity Act.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 2007

  Ms. Eshoo 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 and the Public Health 
   Service Act to reauthorize and amend the Best Pharmaceuticals for 
          Children Act and the Pediatric Research Equity Act.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Improving 
Pharmaceuticals for Children Act of 2007''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Reauthorization of Best Pharmaceuticals for Children Act.
Sec. 3. Reauthorization of Pediatric Research Equity Act.
Sec. 4. Government Accountability Office report.

SEC. 2. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT.

    (a) Pediatric Studies of Drugs.--
            (1) In general.--Section 505A of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355a) is amended to read as 
        follows:

``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age groups (including neonates in appropriate cases) in which 
a drug is anticipated to be used, and at the discretion of the 
Secretary, may include preclinical studies.
    ``(b) Market Exclusivity for New Drugs.--
            ``(1) In general.--Except as provided in paragraph (2), if, 
        prior to approval of an application that is submitted under 
        section 505(b)(1), the Secretary determines that information 
        relating to the use of a new drug in the pediatric population 
        may produce health benefits in that population, the Secretary 
        makes a written request for pediatric studies (which shall 
        include a timeframe for completing such studies), the applicant 
        agrees to the request, such studies are completed using 
        appropriate formulations for each age group for which the study 
        is requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3), and if the Secretary determines that labeling changes 
        are appropriate, such changes are made within the timeframe 
        requested by the Secretary--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(E) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsections (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions).
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        is made later than one year prior to the expiration of such 
        period.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--
            ``(1) In general.--Except as provided in paragraph (2), if 
        the Secretary determines that information relating to the use 
        of an approved drug in the pediatric population may produce 
        health benefits in that population and makes a written request 
        to the holder of an approved application under section 
        505(b)(1) for pediatric studies (which shall include a 
        timeframe for completing such studies), the holder agrees to 
        the request, such studies are completed using appropriate 
        formulations for each age group for which the study is 
        requested within any such timeframe and the reports thereof are 
        submitted and accepted in accordance with subsection (d)(3), 
        and if the Secretary determines that labeling changes are 
        appropriate and such changes are made within the timeframe 
        requested by the Secretary--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(D) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B)(ii) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions)
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        is made later than one year prior to the expiration of such 
        period.
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Request for studies.--
                    ``(A) In general.--The Secretary may, after 
                consultation with the sponsor of an application for an 
                investigational new drug under section 505(I), the 
                sponsor of an application for a new drug under section 
                505(b)(1), or the holder of an approved application for 
                a drug under section 505(b)(1) issue to the sponsor or 
                holder a written request for the conduct of pediatric 
                studies for such drug. In issuing such request, the 
                Secretary shall take into account adequate 
                representation of children of ethnic and racial 
                minorities. Such request to conduct pediatric studies 
                shall be in writing and shall include a timeframe for 
                such studies and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such studies.
                    ``(B) Single written request.--A single written 
                request--
                            ``(i) may related to more than one use of a 
                        drug; and
                            ``(ii) may include uses that are both 
                        approved and unapproved.
            ``(2) Written request for pediatric studies.--
                    ``(A) Request and response.--
                            ``(i) In general.--If the Secretary makes a 
                        written request for pediatric studies 
                        (including neonates, as appropriate) under 
                        subsection (b) or (c), the applicant or holder, 
                        not later than 180 days after receiving the 
                        written request, shall respond to the Secretary 
                        as to the intention of the applicant or holder 
                        to act on the request by--
                                    ``(I) indicating when the pediatric 
                                studies will be initiated, if the 
                                applicant or holder agrees to the 
                                request; or
                                    ``(II) indicating that the 
                                applicant or holder does not agree to 
                                the request and stating the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of the enactment of the 
                        Improving Pharmaceuticals for Children Act of 
                        2007, the applicant or holder does not agree to 
                        the request on the grounds that it is not 
                        possible to develop the appropriate pediatric 
                        formulation, the applicant or holder shall 
                        submit to the Secretary the reasons such 
                        pediatric formulation cannot be developed.
                    ``(B) Adverse event reports.--An applicant or 
                holder that, on or after the date of the enactment of 
                the Improving Pharmaceuticals for Children Act of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as the submission of 
                the reports of such studies, with all postmarket 
                adverse event reports regarding the drug that is the 
                subject of such studies and are available prior to 
                submission of such reports.
            ``(3) Meeting the studies requirement.--Not later than 180 
        days after the submission of the reports of the studies, the 
        Secretary shall accept or reject such reports and so notify the 
        sponsor or holder. The Secretary's only responsibility in 
        accepting or rejecting the reports shall be to determine, 
        within the 180-day period, whether the studies fairly respond 
        to the written request, have been conducted in accordance with 
        commonly accepted scientific principles and protocols, and have 
        been reported in accordance with the requirements of the 
        Secretary for filing.
            ``(4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(e) Notice of Determinations on Studies Requirement.--
            ``(1) In general.--The Secretary shall publish a notice of 
        any determination, made on or after the date of the enactment 
        of the Improving Pharmaceuticals for Children Act of 2007, that 
        the requirements of subsection (d) have been met and that 
        submissions and approvals under subsection (b)(2) or (j) of 
        section 505 for a drug will be subject to the provisions of 
        this section. Such notice shall be published not later than 30 
        days after the date of the Secretary's determination regarding 
        market exclusivity and shall include a copy of the written 
        request made under subsection (b) or (c).
            ``(2) Identification of certain drugs.--The Secretary shall 
        publish a notice identifying any drug for which, on or after 
        the date of the enactment of the Improving Pharmaceuticals for 
        Children Act of 2007, a pediatric formulation was developed, 
        studied, and found to be safe and effective in the pediatric 
        population (or specified subpopulation) if the pediatric 
        formulation for such drug is not introduced onto the market 
        within one year after the date that the Secretary publishes the 
        notice described in paragraph (1). Such notice identifying such 
        drug shall be published not later than 30 days after the date 
        of the expiration of such one year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--
                    ``(A) In general.--The Secretary shall establish an 
                internal review committee to review all written 
                requests issued on or after the date of the enactment 
                of the Improving Pharmaceuticals for Children Act of 
                2007, in accordance with paragraph (2).
                    ``(B) Members.--The committee established under 
                subparagraph (A) shall include individuals with 
                expertise in pediatrics, biopharmacology, statistics, 
                drugs and drug formulations, legal issues, pediatric 
                ethics, the appropriate expertise, such as expertise in 
                child and adolescent psychiatry, pertaining to the 
                pediatric product under review, one or more experts 
                from the Office of Pediatric Therapeutics, and other 
                individuals designated by the Secretary.
            ``(2) Review of written requests.--The committee 
        established under paragraph (1) shall review all written 
        requests issued pursuant to this section prior to being issued.
            ``(3) Tracking pediatric studies and labeling changes.--The 
        Secretary shall track and make available to the public, in an 
        easily accessible manner, including through posting on the 
        website of the Food and Drug Administration--
                    ``(A) the number of studies conducted under this 
                section and under section 409I of the Public Health 
                Service Act (42 U.S.C. 284m);
                    ``(B) the specific drugs and biological products 
                and their uses, including labeled and off-labeled 
                indications, studied under such sections;
                    ``(C) the types of studies conducted under such 
                sections, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons such formulations were not 
                developed;
                    ``(E) the labeling changes made as a result of 
                studies conducted under such sections;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under such sections for 
                distribution pursuant to subsection (k)(2); and
                    ``(G) information regarding reports submitted on or 
                after the date of the enactment of the Improving 
                Pharmaceuticals for Children Act of 2007.
            ``(4) Committee.--The Committee established under paragraph 
        (1) is the committee established in section 505B(f)(1).''
    ``(g) Limitations.--Notwithstanding subsection (c)(2), a drug to 
which the six-month period under subsection (b) or (c) has already been 
applied--
            ``(1) may receive an additional six-month period under 
        subsection (c)(1)(A)(i)(II) for a supplemental application if 
        all other requirements under this section are satisfied; and
            ``(2) may not receive any additional such period under 
        subsection (c)(1)(A)(ii).
    ``(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric study is 
required by a provision of law (including a regulation) other than this 
section and such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed to satisfy the 
requirement for market exclusivity pursuant to this section.
    ``(i) Labeling Changes.--
            ``(1) Priority status for pediatric applications and 
        supplements.--Any application or supplement to an application 
        under section 505 proposing a labeling change as a result of 
        any pediatric study conducted pursuant to this section--
                    ``(A) shall be considered to be a priority 
                application or supplement; and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If, on or after the date of the enactment of 
                the Improving Pharmaceuticals for Children Act of 2007, 
                the Commissioner determines that the sponsor and the 
                Commissioner have been unable to reach agreement on 
                appropriate changes to the labeling for the drug that 
                is the subject of the application, not later than 180 
                days after the date of submission of the application--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor of the application 
                        does not agree within 30 days after the 
                        Commissioner's request to make a labeling 
                        change requested by the Commissioner, the 
                        Commissioner shall refer the matter to the 
                        Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application to 
                make any labeling change that the Commissioner 
                determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a request 
                under subparagraph (c), does not agree to make a 
                labeling change requested by the Commissioner, the 
                Commissioner may deem the drug that is the subject of 
                the application to be misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
    ``(j) Other Labeling Changes.--If, on or after the date of the 
enactment of the Improving Pharmaceuticals for Children Act of 2007, 
the Secretary determines that a pediatric study conducted under this 
section does or does not demonstrate that the drug that is the subject 
of the study is safe and effective in pediatric populations or 
subpopulations, including whether such study results are inconclusive, 
the Secretary shall order the labeling of such product to include 
information about the results of the study and a statement of the 
Secretary's determination.
    ``(k) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a report on a pediatric study under this 
        section, the Secretary shall make available to the public the 
        medical, statistical, and clinical pharmacology reviews of 
        pediatric studies conducted under subsection (b) or (c).
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the 
        Improving Pharmaceuticals for Children Act of 2007, the 
        Secretary shall require that the sponsors of the studies that 
        result in labeling changes that are reflected in the annual 
        summary developed pursuant to subsection (f)(3)(F) distribute, 
        at least annually (or more frequently if the Secretary 
        determines that it would be beneficial to the public health), 
        such information to physicians and other health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of the 
        enactment of the Improving Pharmaceuticals for Children Act of 
        2007, during the one-year period beginning on the date a 
        labeling change is made pursuant to subsection (I), the 
        Secretary shall ensure that all adverse event reports that have 
        been received for such drug (regardless of when such report was 
        received) are referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals for 
        Children Act (Public Law 107-109). In considering the reports, 
        the Director of such Office shall provide for the review of the 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendations of such Committee regarding 
        whether the Secretary should take action under this Act in 
        response to such reports.
            ``(2) Reporting in subsequent years.--Following the one-
        year period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such reports.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.
    ``(m) Clarification of Interaction of Market Exclusivity Under This 
Section and Market Exclusivity Awarded to An Applicant for Approval of 
A Drug Under Section 505(j).--If a 180-day period under section 
505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this 
section, so that the applicant for approval of a drug under section 
505(j) entitled to the 180-day period under that section loses a 
portion of the 180-day period to which the applicant is entitled for 
the drug, the 180-day period shall be extended from--
            ``(1) the date on which the 180-day period would have 
        expired by the number of days of the overlap, if the 180-day 
        period would, but for the application of this subsection, 
        expire after the 6-month exclusivity period; or
            ``(2) the date on which the 6-month exclusivity period 
        expires, by the number of days of the overlap if the 180-day 
        period would, but for the application of this subsection, 
        expire during the six-month exclusivity period.
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of the enactment 
        of the Improving Pharmaceuticals for Children Act of 2007, if 
        pediatric studies have not been completed under subsection (d) 
        and if the Secretary, through the committee established under 
        subsection (f), determines that there is a continuing need for 
        information relating to the use of the drug in the pediatric 
        population (including neonates, as appropriate), the Secretary 
        shall--
                    ``(A) for a drug for which listed patents have not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B; or
                    ``(B) for a drug that has no listed patents or has 
                1 or more listed patents that have expired, determine 
                whether there are funds available under section 736 to 
                award a grant to conduct the requested studies pursuant 
                to paragraph (2).
            ``(2) Funding of studies.--If, pursuant to paragraph (1), 
        the Secretary determines that there are funds available under 
        section 736 to award a grant to conduct the requested pediatric 
        studies, then the Secretary shall issue a proposal to award a 
        grant to conduct the requested studies. If the Secretary 
        determines that funds are not available under section 736, the 
        Secretary shall refer the drug for inclusion on the list 
        established under section 409I of the Public Health Services 
        Act or the conduct of studies.
            ``(3) Public notice.--The Secretary shall give the public 
        notice of--
                    ``(A) a decision under paragraph (1)(A) not to 
                require an assessment under section 505B and the basis 
                for such decision;
                    ``(B) the name of any drug, its manufacturer, and 
                the indications to be studied pursuant to a grant made 
                under paragraph (2); and
                    ``(C) any decision under paragraph (2) to include a 
                drug on the list established under section 409I of the 
                Public Health Services Act.
            ``(4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of Title 18, United States Code
    ``(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric 
Information Is Added to Labeling.--
            ``(1) General rule.--A drug for which an application has 
        been submitted or approved under section 505(j) shall not be 
        considered ineligible for approval under that section or 
        misbranded under section 502 on the basis that the labeling of 
        the drug omits a pediatric indication or any other aspect of 
        labeling pertaining to pediatric use when the omitted 
        indication or other aspect is protected by patent or by 
        exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).
            ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
        section 505(j)(5)(F), the Secretary may require that the 
        labeling of a drug approved under section 505(j) that omits a 
        pediatric indication or other aspect of labeling as described 
        in paragraph (1) include--
                    ``(A) a statement that, because of marketing 
                exclusivity for a manufacturer--
                            ``(i) the drug is not labeled for pediatric 
                        use; or
                            ``(ii) in the case of a drug for which 
                        there is an additional pediatric use not 
                        referred to in paragraph (1), the drug is not 
                        labeled for the pediatric use under paragraph 
                        (1); and
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions that the 
                Secretary considers necessary.
            ``(3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                    ``(A) the availability or scope of exclusivity 
                under this section;
                    ``(B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations;
                    ``(C) the question of the eligibility for approval 
                of any application under section 505(j) that omits any 
                other conditions of approval entitled to exclusivity 
                under clause (iii) or (iv) of section 505(j)(5)(F); or
                    ``(D) except as expressly provided in paragraphs 
                (1) and (2), the operation of section 505.
    ``(p) Institute of Medicine Study.--Not later than 3 years after 
the date of the enactment of the Improving Pharmaceuticals for Children 
Act of 2007, the Secretary shall enter into a contract with the 
Institute of Medicine to conduct a study and report to Congress 
regarding the written requests made and the studies conducted pursuant 
to this section. The Institute of Medicine may devise an appropriate 
mechanism to review a representative sample of requests made and 
studies conducted pursuant to this section in order to conduct such 
study. Such study shall--
            ``(1) review such representative written requests issued by 
        the Secretary since 1997 under subsections (b) and (c);
            ``(2) review and assess such representative pediatric 
        studies conducted under subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies;
            ``(3) review the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, and ethical issues in 
        pediatric clinical trials; and
            ``(4) make recommendations regarding appropriate incentives 
        for encouraging pediatric studies of biologics.
    ``(q) Sunset.--A drug may not receive any 6-month period under 
subsection (b) or (c) unless--
            ``(1) on or before October 1, 2012, the Secretary makes a 
        written request for pediatric studies of the drug;
            ``(2) on or before October 1, 2012, an application for the 
        drug is accepted for filing under section 505(b); and
            ``(3) all requirements of this section are met.''.
            (2) Effective date.--The amendment made by this subsection 
        shall apply to written requests under section 505A of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made 
        after the date of the enactment of this Act.
    (b) Program for Pediatric Studies of Drugs.--Section 409I of the 
Public Health Service Act (42 U.S.C. 284m) is amended to read as 
follows:

``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than one year after the date 
        of the enactment of the Improving Pharmaceuticals for Children 
        Act of 2007, the Secretary, acting through the Director of the 
        National Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs and experts in pediatric 
        research, shall develop and publish a priority list of needs in 
        pediatric therapeutics, including drugs or indications that 
        require study. The list shall be revised every three years.
            ``(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph (1), the 
        Secretary shall consider--
                    ``(A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, pharmacogenetic 
                determinants of drug response, metabolism of drugs and 
                biologics in children, and pediatric clinical trials;
                    ``(B) particular pediatric diseases, disorders or 
                conditions where more complete knowledge and testing of 
                therapeutics, including drugs and biologics, may be 
                beneficial in pediatric populations; and
                    ``(C) the adequacy of necessary infrastructure to 
                conduct pediatric pharmacological research, including 
                research networks and trained pediatric investigators.
    ``(b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, 
laboratories, contract research organizations, practice groups, 
federally funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) to enable 
the entities to conduct the drug studies or other research on the 
issues described in subsection (a). The Secretary may use contracts, 
grants or other appropriate funding mechanisms to award funds under 
this subsection.
    ``(c) Process for Proposed Pediatric Study Requests and Labeling 
Changes.--
            ``(1) Submission of proposed pediatric study request.--The 
        Director of the National Institutes of Health shall, as 
        appropriate, submit proposed pediatric study requests for 
        consideration by the Commissioner of the Food and Drugs for 
        pediatric studies of a specific pediatric indication identified 
        under subsection (a). Such a proposed pediatric study request 
        shall be made in a manner equivalent to a written request made 
        under subsection (b) or (c) of Section 505A of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355a), including with 
        respect to the information provided on the pediatric studies to 
        be conducted pursuant to the request. The Director of the 
        National Institutes of Health may submit a proposed pediatric 
        study request for a drug for which--
                    ``(A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(j)); or
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of such section; and
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least one form of the 
                drug under the Federal Food, Drug, and Cosmetic Act; 
                and
                    ``(C) additional studies are needed to assess the 
                safety and effectiveness of the use of the drug in the 
                pediatric population.
            ``(2) Written request to holders of approved applications 
        for drugs lacking exclusivity.--The Commissioner of the Food 
        and Drugs, in consultation with the Director of the National 
        Institutes of Health, may issue a written request based on the 
        proposed pediatric study request for the indication or 
        indications submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) for 
        pediatric studies concerning a drug identified under subsection 
        (a) to all holders of an approved application for the drug 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355). Such a written request shall be made in a 
        manner equivalent to the manner in which a written request is 
        made under subsection (a) or (b) of section 505A of such Act 
        (21 U.S.C. 355a), including with respect to information 
        provided on the pediatric studies to be conducted pursuant to 
        the request and using appropriate formulations for each age 
        group for which the study is requested.
            ``(3) Requests for proposals.--If the Commissioner of the 
        Food and Drugs does not receive a response to a written request 
        issued under paragraph (2) not later than 30 days after the 
        date on which a request was issued, the Secretary, acting 
        through the Director of the National Institutes of Health and 
        in consultation with the Commissioner of the Food and Drugs, 
        shall publish a request for proposals to conduct the pediatric 
        studies described in the written request in accordance with 
        subsection (b).
            ``(4) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a request 
        for proposals under paragraph (3).
            ``(5) Contracts, grants, or other funding mechanisms.--A 
        contract, grant or other funding may be awarded under this 
        section only if a proposal is submitted to the Secretary in 
        such form and manner, and containing such agreements, 
        assurances, and information as the Secretary determines to be 
        necessary to carry out this section.
            ``(6) Reporting of studies.--
                    ``(A) In general.--On completion of a pediatric 
                study in accordance with an award under this section, a 
                report concerning the study shall be submitted to the 
                Director of the National Institutes of Health and the 
                Commissioner of Food and Drugs. The report shall 
                include all data generated in connection with the 
                study, including a written request if issued.
                    ``(B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be considered to 
                be in the public domain (subject to section 
                505A(d)(4)(D) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355a(d)(4)(D)) and shall be assigned a 
                docket number by the Commissioner of Food and Drugs. An 
                interested person may submit written comments 
                concerning such pediatric studies to the Commissioner 
                of Food and Drugs, and the written comments shall 
                become part of the docket file with respect to each of 
                the drugs.
                    ``(C) Action by commissioner.--The Commissioner of 
                Food and Drugs shall take appropriate action in 
                response to the reports submitted under subparagraph 
                (A) in accordance with paragraph (7).
            ``(7) Requests for labeling change.--During the 180-day 
        period after the date on which a report is submitted under 
        paragraph (6)(A), the Commissioner of Food and Drugs shall--
                    ``(A) review the report and such other data as are 
                available concerning the safe and effective use in the 
                pediatric population of the drug studied;
                    ``(B) negotiate with the holders of approved 
                applications for the drug studied for any labeling 
                changes that the Commissioner of Food and Drugs 
                determines to be appropriate and requests the holders 
                to make; and
                    ``(C)(i) place in the public docket file a copy of 
                the report and of any requested labeling changes; and
                    ``(ii) publish in the Federal Register and through 
                a posting on the website of the Food and Drug 
                Administration a summary of the report and a copy of 
                any requested labeling changes.
            ``(8) Dispute resolution.--
                    ``(A) Referral to pediatric advisory committee.--
                If, not later than the end of the 180-day period 
                specified in paragraph (7), the holder of an approved 
                application for the drug involved does not agree to any 
                labeling change requested by the Commissioner of Food 
                and Drugs under that paragraph, the Commissioner of 
                Food and Drugs shall refer the request to the Pediatric 
                Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the available information on 
                        the safe and effective use of the drug in the 
                        pediatric population, including study reports 
                        submitted under this section; and
                            ``(ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
            ``(9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a drug, 
        the Commissioner of Food and Drugs shall consider the 
        recommendation and, if appropriate, make a request to the 
        holders of approved applications for the drug to make any 
        labeling change that the Commissioner of Food and Drugs 
        determines to be appropriate.
            ``(10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving a 
        request to make a labeling change under paragraph (9), does not 
        agree to make a requested labeling change, the Commissioner of 
        Food and Drugs may deem the drug to be misbranded under the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
            ``(11) No effect on authority.--Nothing in this subsection 
        limits the authority of the United States to bring an 
        enforcement action under the Federal Food, Drug, and Cosmetic 
        Act when a drug lacks appropriate pediatric labeling. Neither 
        course of action (the Pediatric Advisory Committee process or 
        an enforcement action referred to in the preceding sentence) 
        shall preclude, delay, or serve as the basis to stay the other 
        course of action.
    ``(d) Dissemination of Pediatric Information.--Not later than one 
year after the date of the enactment of the Improving Pharmaceuticals 
for Children Act of 2007, the Secretary, acting through the Director of 
the National Institutes of Health, shall study the feasibility of 
establishing a compilation of information on pediatric drug use and 
report the findings to Congress.
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section--
                    ``(A) $200,000,000 for fiscal year 2008; and
                    ``(B) such sums as are necessary for each of the 
                four succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.
    (c) Fees Relating to Drugs.--Section 735(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379(6)) is amended by adding at the 
end the following new subparagraph:
                    ``(G) Activities relating to the support of studies 
                of drugs on pediatric populations under section 
                505A(n)(1).''.
    (d) Training of Pediatric Pharmacologists.--
            (1) Investment in tomorrow's pediatric researchers.--
        Section 452G(2) of the Public Health Service Act (42 U.S.C. 
        285g-10(2)) is amended by inserting before the period at the 
        end the following: ``, including pediatric pharmacological 
        research''.
            (2) Pediatric research loan repayment program.--Section 
        487F(a)(1) of the Public Health Service Act (42 U.S.C. 288-
        6(a)(1)) is amended by inserting ``including pediatric 
        pharmacological research,'' after ``pediatric research,''.
    (e) Foundation for the National Institutes of Health.--Section 
499(c)(1)(c) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(c)) 
is amended by striking ``and studies listed by the Secretary pursuant 
to section 409I(a)(1)(A) of this Act and referred under section 
505A(d)(4)(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(a)(d)(4)(c))''.
    (f) Continuation of Operation of Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by 
adding at the end the following new subsection:
    ``(d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the 
advisory committee shall continue to operate during the five-year 
period beginning on the date of the enactment of the Improving 
Pharmaceuticals for Children Act of 2007.''.
    (g) Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee.--Section 15 of the Best Pharmaceuticals for Children Act (42 
U.S.C. 284m note) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (B), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (c), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
                    ``(D) provide recommendations to the internal 
                review committee created under section 505A(f) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355a(f)) regarding the implementation of amendments to 
                sections 505A and 505B of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355a and 355c) with respect to 
                the treatment of pediatric cancers.''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory Committee 
        Act (5 U.S.C. App.), the Subcommittee shall continue to operate 
        during the five-year period beginning on the date of the 
        enactment of the Improving Pharmaceuticals for Children Act of 
        2007.''; and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.
    (h) Effective Date and Limitation for Rule Relating to Toll-Free 
Number for Adverse Events on Labeling for Human Drug Products.--
            (1) In general.--Notwithstanding subchapter II of chapter 
        5, and chapter 7, of title 5, United States Code (commonly 
        known as the ``Administrative Procedure Act'') and any other 
        provision of law, the proposed rule issued by the Commissioner 
        of Food and Drugs entitled ``Toll-Free Number for Reporting 
        Adverse Events on Labeling for Human Drug Products,'' 69 Fed. 
        Reg. 21778, (April 22, 2004) shall take effect on January 1, 
        2008, unless such Commissioner issues the final rule before 
        such date.
            (2) Limitation.--The proposed rule that takes effect under 
        subsection (a), or the final rule described under subsection 
        (a), shall, notwithstanding section 17(a) of the Best 
        Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply 
        to a drug--
                    (A) for which an application is approved under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355);
                    (B) that is not described under section 503(b)(1) 
                of such Act (21 U.S.C. 353(b)(1)); and
                    (C) the packaging of which includes a toll-free 
                number through which consumers can report complaints to 
                the manufacturer or distributor of the drug.

SEC. 3. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

    Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c) is amended to read as follows:

``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
              PRODUCTS.

    ``(a) New Drugs and Biological Products.--
            ``(1) In general.--A person that submits an application (or 
        supplement to an application)--
                    ``(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration; or
                    ``(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration; shall submit 
                with the application the assessments described in 
                paragraph (2).
            ``(2) Assessments.--
                    ``(A) In general.--The assessments referred to in 
                paragraph (1) shall contain data, gathered using 
                appropriate formulations for each age group for which 
                the assessment is required, that are adequate--
                            ``(i) to assess the safety and 
                        effectiveness of the drug or the biological 
                        product for the claimed indications in all 
                        relevant pediatric subpopulations; and
                            ``(ii) to support dosing and administration 
                        for each pediatric subpopulation for which the 
                        drug or the biological product is safe and 
                        effective.
                    ``(B) Similar course of disease or similar effect 
                of drug or biological product.--
                            ``(i) In general.--If the course of the 
                        disease and the effects of the drug are 
                        sufficiently similar in adults and pediatric 
                        patients, the Secretary may conclude that 
                        pediatric effectiveness can be extrapolated 
                        from adequate and well-controlled studies in 
                        adults, usually supplemented with other 
                        information obtained in pediatric patients, 
                        such as pharmacokinetic studies.
                            ``(ii) Extrapolation between age groups.--A 
                        study may not be needed in each pediatric age 
                        group if data from one age group can be 
                        extrapolated to another age group.
                            ``(iii) Information on extrapolation.--A 
                        brief documentation of the scientific data 
                        supporting the conclusion under clauses (i) and 
                        (ii) shall be included in the medical review 
                        that is collected as part of the application 
                        under section 505 of this Act or section 351 of 
                        the Public Health Service Act (42 U.S.C. 262).
            ``(3) Deferral.--
                    ``(A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may defer submission of some or all 
                assessments required under paragraph (1) until a 
                specified date after approval of the drug or issuance 
                of the license for a biological product if--
                            ``(i) the Secretary finds that--
                                    ``(I) the drug or biological 
                                product is ready for approval for use 
                                in adults before pediatric studies are 
                                complete;
                                    ``(II) pediatric studies should be 
                                delayed until additional safety or 
                                effectiveness data have been collected; 
                                or
                                    ``(III) there is another 
                                appropriate reason for deferral; and
                            ``(ii) the applicant submits to the 
                        Secretary--
                                    ``(I) certification of the grounds 
                                for deferring the assessments;
                                    ``(II) a description of the planned 
                                or ongoing studies;
                                    ``(III) evidence that the studies 
                                are being conducted or will be 
                                conducted with due diligence and at the 
                                earliest possible time; and
                                    ``(IV) a timeline for the 
                                completion of such studies.
                    ``(B) Annual review.--
                            ``(i) In general.--On an annual basis 
                        following the approval of a deferral under 
                        subparagraph (A), the applicant shall submit to 
                        the Secretary the following information:
                                    ``(I) Information detailing the 
                                progress made in conducting pediatric 
                                studies.
                                    ``(II) If no progress has been made 
                                in conducting such studies, evidence 
                                and documentation that such studies 
                                will be conducted with due diligence 
                                and at the earliest possible time.
                            ``(ii) Public availability.--The 
                        information submitted through the annual review 
                        under clause (I) shall promptly be made 
                        available to the public in an easily accessible 
                        manner, including through the website of the 
                        Food and Drug Administration.
            ``(4) Waivers.--
                    ``(A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a full waiver, as appropriate, of 
                the requirement to submit assessments for a drug or 
                biological product under this subsection if the 
                applicant certifies and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients is so small or the patients 
                        are geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups; or
                            ``(iii) The drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients.
                    ``(B) Partial waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a partial waiver, as appropriate, 
                of the requirement to submit assessments for a drug or 
                biological product under this subsection with respect 
                to a specific pediatric age group if the applicant 
                certifies and the secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(II) is not likely to be used by 
                                a substantial number of pediatric 
                                patients in that age group; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial waiver shall submit to the Secretary 
                documentation detailing why a pediatric formulation 
                cannot be developed and, if the waiver is granted, the 
                applicant's submission shall promptly be made available 
                to the public in an easily accessible manner, including 
                through posting on the website of the Food and Drug 
                Administration.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(b) Marketed Drugs and Biological Products.--
            ``(1) In general.--After providing notice in the form of a 
        letter and an opportunity for written response and a meeting, 
        which may include an advisory committee meeting, the Secretary 
        may (by order in the form of a letter) require the sponsor or 
        holder of an approved application for a drug under section 505 
        or the holder of a license for a biological product under 
        section 351 of the Public Health Service Act (42 U.S.C. 262) to 
        submit by a specified date the assessments described in 
        subsection (a)(2) and the written request, as appropriate, if 
        the Secretary finds that--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) adequate pediatric labeling could confer a 
                benefit on pediatric patients;
                    ``(B) there is reason to believe that the drug or 
                biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients for 1 or more of the claimed 
                indications; or
                    ``(C) the absence of adequate pediatric labeling 
                could pose a risk to pediatric patients.
            ``(2) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if the applicant certifies and 
                the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed); or
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if the applicant certifies 
                and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii)(I) the drug or biological product--
                                    ``(aa) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(bb) is not likely to be used in 
                                a substantial number of pediatric 
                                patients in that age group; and
                            ``(II) the absence of adequate labeling 
                        could not pose significant risks to pediatric 
                        patients; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial waiver shall submit to the Secretary 
                documentation detailing why a pediatric formulation 
                cannot be developed and, if the waiver is granted, the 
                applicant's submission shall promptly be made available 
                to the public in an easily accessible manner, including 
                through posting on the website of the Food and Drug 
                Administration.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and 
paragraphs (1)(B)(I) and (2)(B)(iii)(I)(aa) of subsection (b), a drug 
or biological product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary determines 
that--
            ``(1) if approved, the drug or biological product could 
        represent an improvement in the treatment, diagnosis, or 
        prevention of a disease, compared with marketed products 
        adequately labeled for that use in the relevant pediatric 
        population; or
            ``(2) the drug or biological product is in a class of 
        products or for an indication for which there is a need for 
        additional options.
    ``(d) Submission of Assessments.--If a person fails to submit an 
assessment described in subsection (a)(2), or a request for approval of 
a pediatric formulation described in subsection (a) or (b), in 
accordance with applicable provisions of subsections (a) and (b)--
            ``(1) the drug or biological product that is the subject of 
        the assessment or request may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303); but
            ``(2) the failure to submit the assessment or request shall 
        not be the basis for a proceeding--
                    ``(A) to withdraw approval for a drug under section 
                505(e); or
                    ``(B) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act (42 U.S.C. 262).
    ``(e) Meetings.--Before and during the investigational process for 
a new drug or biological product, the Secretary shall meet at 
appropriate times with the sponsor of the new drug or biological 
product to discuss--
            ``(1) information that the sponsor submits on plans and 
        timelines for pediatric studies; or
            ``(2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.
    ``(f) Review of Pediatric Assessments, Deferrals, and Waivers.--
            ``(1) Review.--The Secretary shall create an internal 
        committee to review all pediatric assessments issued under this 
        section and all deferral and waiver requests made pursuant to 
        this section. Such internal committee shall include 
        individuals, each of whom is an employee of the Food and Drug 
        Administration, with expertise in pediatrics, biopharmacology, 
        statistics, drugs and drug formulations, legal issues, 
        pediatric ethics, the appropriate expertise, such as expertise 
        in child and adolescent psychiatry, pertaining to the pediatric 
        product under review, one or more experts from the Office of 
        Pediatric Therapeutics, and other individuals designated by the 
        Secretary.
            ``(2) Action by committee.--The committee established under 
        paragraph (1) may perform a function under this section using 
        appropriate members of the committee described in paragraph (1) 
        and need not convene all members of the committee described in 
        paragraph (1) in order to perform a function under this 
        section.
            ``(3) Documentation of committee action.--For each drug or 
        biological product, the committee established under this 
        paragraph shall document for each function described in 
        paragraph (4) which members of the committee participated in 
        such function.
            ``(4) Review of requests for pediatric assessments, 
        deferrals and waivers.--All requests for a pediatric assessment 
        issued pursuant to this section and all requests for deferrals 
        and waivers from the requirement to conduct a pediatric 
        assessment under this section shall be reviewed by the 
        committee established under paragraph (1).
            ``(5) Tracking of assessments and labeling changes.--The 
        Secretary shall track and make available to the public in an 
        easily accessible manner, including through post on the website 
        of the Food and Drug Administration--
                    ``(A) the number of assessments conducted under 
                this section;
                    ``(B) the specific drugs and biological products 
                and their uses assessed under this section;
                    ``(C) the types of assessments conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the total number of deferrals requested and 
                granted under this section and, if granted, the reasons 
                for such deferrals, the timeline for completion, and 
                the number completed and pending by the specified date, 
                as outlined in subsection (a)(3);
                    ``(E) the number of waivers requested and granted 
                under this section and, if granted, the reasons for the 
                waivers;
                    ``(F) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons any such formulation were not 
                developed;
                    ``(G) the labeling changes made as a result of 
                assessments conducted under this section;
                    ``(H) an annual summary of labeling changes made as 
                a result of assessments conducted under this section 
                for distribution pursuant to subsection (h)(2); and
                    ``(I) an annual summary of information submitted 
                pursuant to subsection (a)(3)(B).
            ``(6) Committee.--The committee established under paragraph 
        (1) is the committee established under section 505A(f)(1).
    ``(g) Labeling Changes.--
            ``(1) Priority status for pediatric applications.--Any 
        supplement to an application under section 505 and section 351 
        of the Public Health Service Act proposing a labeling change as 
        a result of any pediatric assessments conducted pursuant to 
        this section--
                    ``(A) shall be considered a priority application or 
                supplement; and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If the Commissioner determines that a sponsor 
                and the Commissioner have been unable to reach 
                agreement on appropriate changes to the labeling for 
                the drug that is the subject of the application or 
                supplement, not later than 180 days after the date of 
                the submission of the application or supplement--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor does not agree within 
                        30 days after the Commissioner's request to 
                        make a labeling change requested by the 
                        Commissioner, the Commissioner shall refer the 
                        matter to the Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application to 
                make any labeling changes that the Commissioner 
                determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a request 
                under subparagraph (c), does not agree to make a 
                labeling change requested by the Commissioner, the 
                Commissioner may deem the drug that is the subject of 
                the application to be misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
            ``(3) Other labeling changes.--If the Secretary makes a 
        determination that a pediatric assessment conducted under this 
        section does or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective in pediatric 
        populations or subpopulations, including whether such 
        assessment results are inconclusive, the Secretary shall order 
        the label of such product to include information about the 
        results of the assessment and a statement of the Secretary's 
        determination.
    ``(h) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a pediatric assessment under this section, the 
        Secretary shall make available to the public in an easily 
        accessible manner the medical, statistical, and clinical 
        pharmacology reviews of such pediatric assessments, and shall 
        post such assessments on the website of the Food and Drug 
        Administration.
            ``(2) Dissemination of information regarding labeling 
        changes.--The Secretary shall require that the sponsors of the 
        assessments that result in labeling changes that are reflected 
        in the annual summary developed pursuant to subsection 
        (f)(5)(H) distribute such information to physicians and other 
        health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend Section 301(j) of this Act or section 552 
        of title 5 or section 1905 of title 18, United States Code.
    ``(i) Adverse Event Reporting.--
            ``(1) Reporting in year one.--During the one-year period 
        beginning on the date a labeling change is made pursuant to 
        subsection (g), the Secretary shall ensure that all adverse 
        event reports that have been received for such drug (regardless 
        of when such report was received) are referred to the Office of 
        Pediatric Therapeutics. In considering the report, the Director 
        of such Office shall provide for the review of the report by 
        the Pediatric Advisory Committee, including obtaining any 
        recommendations of such committee regarding whether the 
        Secretary should take action under this Act in response to such 
        report.
            ``(2) Reporting in subsequent years.--Following the one-
        year period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering the report, the Director of such Office may provide 
        for the review of the report by the Pediatric Advisory 
        Committee, including obtaining any recommendation of such 
        Committee regarding whether the Secretary should take action in 
        response to such report.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.
    ``(j) Scope of Authority.--Nothing in this section provides to the 
Secretary any authority to require a pediatric assessment of any drug 
or biological product, or any assessment regarding other populations or 
uses of a drug or biological product, other than the pediatric 
assessments described in this section.
    ``(k) Orphan Drugs.--Unless the Secretary requires otherwise by 
regulation, this section does not apply to any drug for an indication 
for which orphan designation has been granted under section 526.
    ``(l) Institute of Medicine Study.--
            ``(1) In general.--Not later than three years after the 
        date of the enactment of the Improving Pharmaceuticals for 
        Children Act of 2007, the Secretary shall contract with the 
        Institute of Medicine to conduct a study and report to Congress 
        regarding the pediatric studies conducted pursuant to this 
        section since 1997.
            ``(2) Content of study.--The study under paragraph (1) 
        shall review and assess--
                    ``(A) pediatric studies conducted pursuant to this 
                section since 1997 and labeling changes made as a 
                result of such studies; and
                    ``(B) the use of extrapolation for pediatric 
                subpopulations, the use of alternative endpoints for 
                pediatric populations, neonatal assessment tools, the 
                number and type of pediatric adverse events, and 
                ethical issues in pediatric clinical trials.
            ``(3) Representative sample.--The Institute of Medicine may 
        devise an appropriate mechanism to review a representative 
        sample of studies conducted pursuant to this section from each 
        review division within the Center for Drug Evaluation and 
        Research in order to make the requested assessment.''.

SEC. 4. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

    Not later than September 1, 2011, the Comptroller General of the 
United States, in consultation with the Secretary of Health and Human 
Services, shall submit to Congress a report that addresses the 
effectiveness of sections 505A and 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health 
Service Act (42 U.S.C. 284m) in ensuring that medicines used by 
children are tested and properly labeled. Such report shall include--
            (1) the number and importance of drugs and biological 
        products for children that are being tested as a result of the 
        amendments made by this Act and the importance for children, 
        health care providers, parents, and others of labeling changes 
        made as a result of such testing;
            (2) the number and importance of drugs and biological 
        products for children that are not being tested for their use 
        notwithstanding the provisions of this Act and possible reasons 
        for the lack of testing, including whether the number of 
        written requests declined by sponsors or holders of drugs 
        subject to section 505A(g)(2) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355a(g)(2)) has increased or decreased 
        as a result of the amendments made by this Act;
            (3) the number of drugs and biological products for which 
        testing is being done and labeling changes required, including 
        the date labeling changes are made and which labeling changes 
        required the use of the dispute resolution process established 
        pursuant to the amendments made by this Act, together with a 
        description of the outcomes of such process, including a 
        description of the disputes and the recommendations of the 
        Pediatric Advisory Committee;
            (4) any recommendations for modifications to the programs 
        established under sections 505A and 505B of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the 
        Public Health Service Act (42 U.S.C. 284m) that the Secretary 
        determines to be appropriate, including a detailed rationale 
        for each recommendation; and
            (5)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonate population; and
            (B) the results of those efforts, including efforts made to 
        encourage the conduct of appropriate studies in neonates by 
        companies with products that have sufficient safety and other 
        information to make the conduct of the studies ethical and 
        safe.
                                 <all>