[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1156 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1156

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the 
               Best Pharmaceuticals for Children program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 18, 2007

  Mr. Dodd (for himself, Mr. Kennedy, Mr. Harkin, Mr. Bingaman, Mrs. 
  Murray, Mrs. Clinton, and Mr. Brown) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the 
               Best Pharmaceuticals for Children program.

    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 ``Best Pharmaceuticals for Children 
Amendments of 2007''.

SEC. 2. PEDIATRIC STUDIES OF DRUGS.

    (a) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsection (a), by inserting before the period at 
        the end the following: ``, and, at the discretion of the 
        Secretary, may include preclinical studies'';
            (2) in subsection (b)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(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--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) later 
        than 9 months prior to the expiration of such period.'';
            (3) in subsection (c)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(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, such changes are made within the timeframe 
        requested by the Secretary--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) later 
        than 9 months prior to the expiration of such period.'';
            (4) by striking subsection (d) and inserting the following:
    ``(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 relate to more than 1 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 the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of enactment of the Best 
                        Pharmaceuticals for Children Amendments 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 enactment of the 
                Best Pharmaceuticals for Children Amendments of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as 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 days, 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.'';
            (5) by striking subsections (e) and (f) and inserting the 
        following:
    ``(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 enactment of 
        the Best Pharmaceuticals for Children Amendments 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 enactment of the Best Pharmaceuticals for Children 
        Amendments 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 1 year of 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 1 year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--
                    ``(A) In general.--The Secretary shall create an 
                internal review committee to review all written 
                requests issued and all reports submitted on or after 
                the date of enactment of the Best Pharmaceuticals for 
                Children Amendments of 2007, in accordance with 
                paragraphs (2) and (3).
                    ``(B) Members.--The committee under subparagraph 
                (A) shall include individuals, each of whom is an 
                employee of the Food and Drug Administration, with the 
                following expertise:
                            ``(i) Pediatrics.
                            ``(ii) Biopharmacology.
                            ``(iii) Statistics.
                            ``(iv) Drugs and drug formulations.
                            ``(v) Legal issues.
                            ``(vi) Appropriate expertise pertaining to 
                        the pediatric product under review.
                            ``(vii) One or more experts from the Office 
                        of Pediatric Therapeutics, including an expert 
                        in pediatric ethics.
                            ``(viii) Other individuals as designated by 
                        the Secretary.
            ``(2) Review of written requests.--All written requests 
        under this section shall be reviewed and approved by the 
        committee established under paragraph (1) prior to being 
        issued.
            ``(3) Review of pediatric studies.--The committee 
        established under paragraph (1) shall review all studies 
        conducted pursuant to this section to determine whether to 
        accept or reject such reports under subsection (d)(3).
            ``(4) Tracking pediatric studies and labeling changes.--The 
        committee established under paragraph (1) shall be responsible 
        for tracking and making 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;
                    ``(B) the specific drugs and drug uses, including 
                labeled and off-labeled indications, studied under this 
                section;
                    ``(C) the types of studies conducted under this 
                section, 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 this section;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under this section for 
                distribution pursuant to subsection (k)(2); and
                    ``(G) information regarding reports submitted on or 
                after the date of enactment of the Best Pharmaceuticals 
                for Children Amendments of 2007.'';
            (6) in subsection (g)--
                    (A) in paragraph (1)--
                            (i) by striking ``(c)(1)(A)(ii)'' and 
                        inserting ``(c)(1)(A)(i)(II)''; and
                            (ii) by striking ``(c)(2)'' and inserting 
                        ``(c)(1)(B)'';
                    (B) in paragraph (2), by striking ``(c)(1)(B)'' and 
                inserting ``(c)(1)(A)(ii)'';
                    (C) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively;
                    (D) by striking ``Limitations.--A drug'' and 
                inserting ``Limitations.--
            ``(1) In general.--Notwithstanding subsection (c)(2), a 
        drug''; and
                    (E) by adding at the end the following:
            ``(2) Exclusivity adjustment.--
                    ``(A) Adjustment.--
                            ``(i) In general.--With respect to any 
                        drug, if the organization designated under 
                        subparagraph (B) notifies the Secretary that 
                        the combined annual gross sales for all drugs 
                        with the same active moiety exceeded 
                        $1,000,000,000 in any calendar year prior to 
                        the time the sponsor or holder agrees to the 
                        initial written request pursuant to subsection 
                        (d)(2), then each period of market exclusivity 
                        deemed or extended under subsection (b) or (c) 
                        shall be reduced by 3 months for such drug.
                            ``(ii) Determination.--The determination 
                        under clause (i) of the combined annual gross 
                        sales shall be determined--
                                    ``(I) taking into account only 
                                those sales within the United States; 
                                and
                                    ``(II) taking into account only the 
                                sales of all drugs with the same active 
                                moiety of the sponsor or holder and its 
                                affiliates.
                    ``(B) Designation.--The Secretary shall designate 
                an organization other than the Food and Drug 
                Administration to evaluate whether the combined annual 
                gross sales for all drugs with the same active moiety 
                exceeded $1,000,000,000 in a calendar year as described 
                in subparagraph (A). Prior to designating such 
                organization, the Secretary shall determine that such 
                organization is independent and is qualified to 
                evaluate the sales of pharmaceutical products. The 
                Secretary shall re-evaluate the designation of such 
                organization once every 3 years.
                    ``(C) Notification.--Once a year at a time 
                designated by the Secretary, the organization 
                designated under subparagraph (B) shall notify the Food 
                and Drug Administration of all drugs with the same 
                active moiety with combined annual gross sales that 
                exceed $1,000,000,000 during the previous calendar 
                year.''.
            (7) in subsection (i)--
                    (A) in the heading, by striking ``Supplements'' and 
                inserting ``Changes'';
                    (B) in paragraph (1)--
                            (i) in the heading, by inserting 
                        ``applications and'' after ``pediatric'';
                            (ii) by inserting ``application or'' after 
                        ``Any'';
                            (iii) by striking ``change pursuant to a 
                        report on a pediatric study under'' and 
                        inserting ``change as a result of any pediatric 
                        study conducted pursuant to''; and
                            (iv) by inserting ``application or'' after 
                        ``to be a priority''; and
                    (C) in paragraph (2)(A), by--
                            (i) striking ``If the Commissioner'' and 
                        inserting ``If, on or after the date of 
                        enactment of the Best Pharmaceuticals for 
                        Children Amendments of 2007, the 
                        Commissioner''; and
                            (ii) striking ``an application with'' and 
                        all that follows through ``on appropriate'' and 
                        inserting ``the sponsor and the Commissioner 
                        have been unable to reach agreement on 
                        appropriate'';
            (8) by striking subsection (m);
            (9) by redesignating subsections (j), (k), (l), and (n), as 
        subsections (k), (m), (o), and (p), respectively;
            (10) by inserting after subsection (i) the following:
    ``(j) Other Labeling Changes.--If, on or after the date of 
enactment of the Best Pharmaceuticals for Children Amendments 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, including whether such study 
results are inconclusive, in pediatric populations or subpopulations, 
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.'';
            (11) in subsection (k), as redesignated by paragraph (9)--
                    (A) in paragraph (1)--
                            (i) by striking ``a summary of the medical 
                        and'' and inserting ``the medical, statistical, 
                        and''; and
                            (ii) by striking ``for the supplement'' and 
                        all that follows through the period and 
                        inserting ``under subsection (b) or (c).'';
                    (B) by redesignating paragraph (2) as paragraph 
                (3); and
                    (C) by inserting after paragraph (1) the following:
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of enactment of the Best 
        Pharmaceuticals for Children Amendments 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)(4)(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.'';
            (12) by inserting after subsection (k), as redesignated by 
        paragraph (9), the following:
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        of 2007, during the 1-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 such reports, 
        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 section in response to 
        such reports.
            ``(2) Reporting in subsequent years.--Following the 1-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.'';
            (13) by inserting after subsection (m), as redesignated by 
        paragraph (9), the following:
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007, if 
        pediatric studies of a drug 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 carry out the following:
                    ``(A) For a drug for which a listed patent has not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B. Prior to making such determination, the 
                Secretary may take not more than 60 days to certify 
                whether the Foundation for the National Institutes of 
                Health has sufficient funding at the time of such 
                certification to initiate 1 or more of the pediatric 
                studies of such drug referred to in the sentence 
                preceding this paragraph and fund 1 or more of such 
                studies in their entirety. Only if the Secretary makes 
                such certification in the affirmative, the Secretary 
                shall refer such pediatric study or studies to the 
                Foundation for the National Institutes of Health for 
                the conduct of such study or studies.
                    ``(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 Service Act 
        for 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 refer a 
                drug for inclusion on the list established under 
                section 409I of the Public Health Service 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.''; and
            (14) in subsection (p), as redesignated by paragraph (9)--
                    (A) striking ``6-month period'' and inserting ``3-
                month or 6-month period'';
                    (B) by striking ``subsection (a)'' and inserting 
                ``subsection (b)''; and
                    (C) by striking ``2007'' both places it appears and 
                inserting ``2012''.
    (b) Effective Date.--Except as otherwise provided in the amendments 
made by subsection (a), such amendments 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 enactment of this Act.

SEC. 3. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    Section 409I of the Public Health Service Act (42 U.S.C. 284m) is 
amended--
            (1) by striking subsections (a) and (b) and inserting the 
        following:
    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        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 3 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.'';
            (2) in subsection (c)--
                    (A) in the heading, by striking ``Contracts'' and 
                inserting ``Proposed Pediatric Study Requests'';
                    (B) by striking paragraphs (4) and (12);
                    (C) by redesignating paragraphs (1), (2), and (3), 
                as paragraphs (2), (3), and (4);
                    (D) by inserting before paragraph (2), as 
                redesignated by subparagraph (C), the following:
            ``(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 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, 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; or
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act;
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least 1 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.'';
                    (E) in paragraph (2), as redesignated by 
                subparagraph (C)--
                            (i) by inserting ``based on the proposed 
                        pediatric study request for the indication or 
                        indications submitted pursuant to paragraph 
                        (1)'' after ``issue a written request'';
                            (ii) by striking ``in the list described in 
                        subsection (a)(1)(A) (except clause (iv))'' and 
                        inserting ``under subsection (a)''; and
                            (iii) by inserting ``and using appropriate 
                        formulations for each age group for which the 
                        study is requested'' before the period at the 
                        end;
                    (F) in paragraph (3), as redesignated by 
                subparagraph (C)--
                            (i) in the heading, by striking 
                        ``contracts'';
                            (ii) by striking ``paragraph (1)'' and 
                        inserting ``paragraph (2)'';
                            (iii) by striking ``or if a referral 
                        described in subsection (a)(1)(A)(iv) is 
                        made,'';
                            (iv) by striking ``for contract proposals'' 
                        and inserting ``for proposals''; and
                            (v) by inserting ``in accordance with 
                        subsection (b)'' before the period at the end;
                    (G) in paragraph (4), as redesignated by 
                subparagraph (C)--
                            (i) by striking ``contract''; and
                            (ii) by striking ``paragraph (2)'' and 
                        inserting ``paragraph (3)'';
                    (H) in paragraph (5)--
                            (i) by striking the heading and inserting 
                        ``Contracts, grants, or other funding 
                        mechanisms''; and
                            (ii) by striking ``A contract'' and all 
                        that follows through ``is submitted'' and 
                        inserting ``A contract, grant, or other funding 
                        may be awarded under this section only if a 
                        proposal is submitted'';
                    (I) in paragraph (6)(A)--
                            (i) by striking ``a contract awarded'' and 
                        inserting ``an award''; and
                            (ii) by inserting ``, including a written 
                        request if issued'' after ``with the study''; 
                        and
            (3) by inserting after subsection (c) the following:
    ``(d) Dissemination of Pediatric Information.--Not later than 1 
year after the date of enactment of the Best Pharmaceuticals for 
Children Amendments 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 4 
                succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.

SEC. 4. REPORTS AND STUDIES.

    (a) GAO Report.--Not later than January 31, 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 section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by 
children are tested and properly labeled, including--
            (1) the number and importance of drugs 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 for children that 
        are not being tested for their use notwithstanding the 
        provisions of this Act and the amendments made by 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 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 section 505A of the Federal Food, Drug and 
        Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public 
        Health Service Act 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.
    (b) IOM Study.--Not later than 3 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 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 section 505A of the Federal Food, Drug, and 
Cosmetic Act. The Institute of Medicine may devise an appropriate 
mechanism to review a representative sample of requests made and 
studies conducted pursuant to such 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) of such 
        section 505A;
            (2) review and assess such representative pediatric studies 
        conducted under such subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies; and
            (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.

SEC. 5. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

    (a) 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 adding before the period at the end the following: ``, 
including pediatric pharmacological research''.
    (b) 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,''.

SEC. 6. 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 the is 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)'' and inserting ``and studies for which the 
Secretary issues a certification under section 505A(n)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(n)(1)(A))''.

SEC. 7. 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:
    ``(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 5-year period 
beginning on the date of enactment of the Best Pharmaceuticals for 
Children Amendments of 2007.''.

SEC. 8. 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:
                    ``(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:
            ``(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 5-year period beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007.''; 
        and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.

SEC. 9. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE 
              NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN DRUG 
              PRODUCTS.

    (a) 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.
    (b) 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--
            (1) for which an application is approved under section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
            (2) that is not described under section 503(b)(1) of such 
        Act (21 U.S.C. 353(b)(1)); and
            (3) the packaging of which includes a toll-free number 
        through which consumers can report complaints to the 
        manufacturer or distributor of the drug.
                                 <all>