[Congressional Record (Bound Edition), Volume 147 (2001), Part 14]
[Senate]
[Pages 20307-20311]
[From the U.S. Government Publishing Office, www.gpo.gov]



                           TEXT OF AMENDMENTS

  SA 1905. Mr. DODD (for himself and Mr. DeWine) proposed an amendment 
to the bill S. 838, to amend the Federal Food, Drug, and Cosmetic Act 
to improve the safety and efficacy of pharmaceuticals for children; as 
follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Best Pharmaceuticals for 
     Children Act''.

     SEC. 2. PEDIATRIC STUDIES OF ALREADY-MARKETED DRUGS.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) is amended--
       (1) by striking subsection (b); and
       (2) in subsection (c)--
       (A) by inserting after ``the Secretary'' the following: 
     ``determines that information relating to the use of an 
     approved drug in the pediatric population may produce health 
     benefits in that population and''; and
       (B) by striking ``concerning a drug identified in the list 
     described in subsection (b)''.

     SEC. 3. RESEARCH FUND FOR THE STUDY OF DRUGS LACKING 
                   EXCLUSIVITY.

       Part B of title IV of the Public Health Service Act (42 
     U.S.C. 284 et seq.) is amended--
       (1) by redesignating the second section 409C, relating to 
     clinical research (42 U.S.C. 284k), as section 409G;
       (2) by redesignating the second section 409D, relating to 
     enhancement awards (42 U.S.C. 284l), as section 409H; and
       (3) by adding at the end the following:

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

       ``(a) List of Drugs for Which Pediatric Studies Are 
     Needed.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, 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, prioritize, and 
     publish an annual list of approved drugs 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));
       ``(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 (21 U.S.C. 355(j));
       ``(iii) there is no patent protection or market exclusivity 
     protection under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.); or
       ``(iv) there is a referral for inclusion on the list under 
     section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355a(d)(4)(C)); and
       ``(B) in the case of a drug referred to in clause (i), 
     (ii), or (iii) of subparagraph (A), additional studies are 
     needed to assess the safety and effectiveness of the use of 
     the drug in the pediatric population.
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary shall consider, for each drug on the list--
       ``(A) the availability of information concerning the safe 
     and effective use of the drug in the pediatric population;
       ``(B) whether additional information is needed;
       ``(C) whether new pediatric studies concerning the drug may 
     produce health benefits in the pediatric population; and
       ``(D) whether reformulation of the drug is necessary;
       ``(b) Contracts for Pediatric Studies.--The Secretary shall 
     award contracts to entities that have the expertise to 
     conduct pediatric clinical trials (including qualified 
     universities, hospitals, laboratories, contract research 
     organizations, federally funded programs such as pediatric 
     pharmacology research units, other public or private 
     institutions, or individuals) to enable the entities to 
     conduct pediatric studies concerning one or more drugs 
     identified in the list described in subsection (a).
       ``(c) Process for Contracts and Labeling Changes.--
       ``(1) Written request to holders of approved applications 
     for drugs lacking exclusivity.--The Commissioner of Food and 
     Drugs, in consultation with the Director of the National 
     Institutes of Health, may issue a written request (which 
     shall include a timeframe for negotiations for an agreement) 
     for pediatric studies concerning a drug identified in the 
     list described in subsection (a)(1)(A) (except clause (iv)) 
     to all holders of an approved application for the drug under 
     section 505 of the Federal Food, Drug, and Cosmetic Act. Such 
     a request shall be made in accordance with section 505A of 
     the Federal Food, Drug, and Cosmetic Act.
       ``(2) Requests for contract proposals.--If the Commissioner 
     of Food and Drugs does not receive a response to a written 
     request issued under paragraph (1) within 30 days of the date 
     on which a request was issued, or if a referral described in 
     subsection (a)(1)(A)(iv) is made, the Secretary, acting 
     through the Director of the National Institutes of Health and 
     in consultation with the Commissioner of Food and Drugs, 
     shall publish a request for contract proposals to conduct the 
     pediatric studies described in the written request.
       ``(3) Disqualification.--A holder that receives a first 
     right of refusal shall not be entitled to respond to a 
     request for contract proposals under paragraph (2).
       ``(4) Guidance.--Not later than 270 days after the date of 
     enactment of this section, the Commissioner of Food and Drugs 
     shall promulgate guidance to establish the process for the 
     submission of responses to written requests under paragraph 
     (1).
       ``(5) Contracts.--A contract under this section may be 
     awarded only if a proposal for the contract 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 a contract awarded 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.
       ``(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 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 may 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 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 section 502 when a drug lacks 
     appropriate pediatric labeling.
       ``(12) Recommendation for formulation changes.--If a 
     pediatric study completed under public contract indicates 
     that a formulation change is necessary and the Secretary 
     agrees, the Secretary shall send a nonbinding letter of 
     recommendation regarding that change to each holder of an 
     approved application.
       ``(d) Authorization of Appropriations.--

[[Page 20308]]

       ``(1) In general.--There are authorized to be appropriated 
     to carry out this section--
       ``(A) $200,000,000 for fiscal year 2002; and
       ``(B) such sums as are necessary for each of the 5 
     succeeding fiscal years.
       ``(2) Availability.--Any amount appropriated under 
     paragraph (1) shall remain available to carry out this 
     section until expended.''.

     SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS 
                   FOR DRUGS THAT HAVE MARKET EXCLUSIVITY.

       Section 505A(d) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a(d)) is amended by adding at the end the 
     following:
       ``(4) Written request to holders of approved applications 
     for drugs that have market exclusivity.--
       ``(A) Request and response.--If the Secretary makes a 
     written request for pediatric studies (including neonates, as 
     appropriate) under subsection (c) to the holder of an 
     application approved under section 505(b)(1), the holder, not 
     later than 180 days after receiving the written request, 
     shall respond to the Secretary as to the intention of the 
     holder to act on the request by--
       ``(i) indicating when the pediatric studies will be 
     initiated, if the holder agrees to the request; or
       ``(ii) indicating that the holder does not agree to the 
     request.
       ``(B) No agreement to request.--
       ``(i) Referral.--If the holder does not agree to a written 
     request within the time period specified in subparagraph (A), 
     and if the Secretary 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 refer the drug to the Foundation for the 
     National Institutes of Health established under section 499 
     of the Public Health Service Act (42 U.S.C. 290b) (referred 
     to in this paragraph as the `Foundation') for the conduct of 
     the pediatric studies described in the written request.
       ``(ii) Public notice.--The Secretary shall give public 
     notice of the name of the drug, the name of the manufacturer, 
     and the indications to be studied made in a referral under 
     clause (i).
       ``(C) Lack of funds.--On referral of a drug under 
     subparagraph (B)(i), the Foundation shall issue a proposal to 
     award a grant to conduct the requested studies unless the 
     Foundation certifies to the Secretary, within a timeframe 
     that the Secretary determines is appropriate through 
     guidance, that the Foundation does not have funds available 
     to conduct the requested studies. If the Foundation so 
     certifies, 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 the studies.
       ``(D) Effect of subsection.--Nothing in this subsection 
     (including with respect to referrals from the Secretary to 
     the Foundation) 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) No requirement to refer.--Nothing in this subsection 
     shall be construed to require that every declined written 
     request shall be referred to the Foundation.
       ``(F) Use of drug.--Research conducted under this paragraph 
     using a commercially available drug shall be considered to be 
     an activity conducted for the purpose of development and 
     submission of information to the Secretary under this Act.
       ``(G) Written requests under subsection (b).--For drugs 
     under subsection (b) for which written requests have not been 
     accepted, if the Secretary 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 issue a written request 
     under subsection (c) after the date of approval of the 
     drug.''.

     SEC. 5. TIMELY LABELING CHANGES FOR DRUGS GRANTED 
                   EXCLUSIVITY; DRUG FEES.

       (a) Elimination of User Fee Waiver for Pediatric 
     Supplements.--Section 736(a)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(a)(1)) is amended--
       (1) by striking subparagraph (F); and
       (2) by redesignating subparagraph (G) as subparagraph (F).
       (b) Labeling Changes.--
       (1) Definition of priority supplement.--Section 201 of the 
     Federal Food Drug, and Cosmetic Act (21 U.S.C. 321) is 
     amended by adding at the end the following:
       ``(kk) Priority supplement.--The term `priority supplement' 
     means a drug application referred to in section 101(4) of the 
     Food and Drug Administration Modernization Act of 1997 (111 
     Stat. 2298).''.
       (2) Treatment as priority supplements.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended by adding at the end the following:
       ``(l) Labeling Supplements.--
       ``(1) Priority status for pediatric supplements.--Any 
     supplement to an application under section 505 proposing a 
     labeling change pursuant to a report on a pediatric study 
     under this section--
       ``(A) shall be considered to be a priority 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 an application with respect 
     to which a pediatric study is conducted under this section is 
     approvable and that the only open issue for final action on 
     the application is the reaching of an agreement between the 
     sponsor of the application and the Commissioner 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 to 
     make a labeling change requested by the Commissioner, the 
     Commissioner may 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 section 502 when a drug lacks 
     appropriate pediatric labeling.''.

     SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

       (a) Establishment.--The Secretary of Health and Human 
     Services shall establish an Office of Pediatric Therapeutics 
     within the Office of the Commissioner of Food and Drugs.
       (b) Duties.--The Office of Pediatric Therapeutics shall be 
     responsible for oversight and coordination of all activities 
     of the Food and Drug Administration that may have any effect 
     on a pediatric population or the practice of pediatrics or 
     may in any other way involve pediatric issues.
       (c) Staff.--The staff of the Office of Pediatric 
     Therapeutics shall include--
       (1) employees of the Department of Health and Human 
     Services who, as of the date of enactment of this Act, 
     exercise responsibilities relating to pediatric therapeutics;
       (2) 1 or more additional individuals with expertise 
     concerning ethical issues presented by the conduct of 
     clinical research in the pediatric population; and
       (3) 1 or more additional individuals with expertise in 
     pediatrics who shall consult and collaborate with all 
     components of the Food and Drug Administration concerning 
     activities described in subsection (b).

     SEC. 7. NEONATES.

       Section 505A(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a(g)) is amended by inserting ``(including 
     neonates in appropriate cases)'' after ``pediatric age 
     groups''.

     SEC. 8. SUNSET.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) is amended by striking subsection (j) and 
     inserting the following:
       ``(j) Sunset.--A drug may not receive any 6-month period 
     under subsection (a) or (c) unless--
       ``(1) on or before October 1, 2007, the Secretary makes a 
     written request for pediatric studies of the drug;
       ``(2) on or before October 1, 2007, an application for the 
     drug is submitted under section 505(b)(1); and
       ``(3) all requirements of this section are met.''.

     SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C 355a) (as amended by section 5(b)(2)) is amended by 
     adding at the end the following:
       ``(m) 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 Commissioner shall make available to the public 
     a summary of the medical and clinical pharmacology reviews of 
     pediatric studies conducted for the supplement, including by 
     publication in the Federal Register.
       ``(2) 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.''.

[[Page 20309]]



     SEC. 10. CLARIFICATION OF INTERACTION OF PEDIATRIC 
                   EXCLUSIVITY UNDER SECTION 505A OF THE FEDERAL 
                   FOOD, DRUG, AND COSMETIC ACT AND 180-DAY 
                   EXCLUSIVITY AWARDED TO AN APPLICANT FOR 
                   APPROVAL OF A DRUG UNDER SECTION 505(J) OF THAT 
                   ACT.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) (as amended by section 9) is amended by 
     adding at the end the following:
       ``(n) 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).--
       ``(1) In general.--If a 180-day period under section 
     505(j)(5)(B)(iv) overlaps with a 6-month extension 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--
       ``(A) if the 180-day period would, but for this subsection, 
     expire after the 6-month extension, by the number of days of 
     the overlap; or
       ``(B) if the 180-day period would, but for this subsection, 
     expire during the 6-month extension, by 6 months.
       ``(2) Effect of subsection.--Under no circumstances shall 
     application of this section result in an applicant for 
     approval of a drug under section 505(j) being enabled to 
     commercially market the drug to the exclusion of a subsequent 
     applicant for approval of a drug under section 505(j) for 
     more than 180 days.''.

     SEC. 11. PROMPT APPROVAL OF DRUGS UNDER SECTION 505(J) WHEN 
                   PEDIATRIC INFORMATION IS ADDED TO LABELING.

       (a) In General.--Section 505A of the Federal Food, Drug, 
     and Cosmetics Act (21 U.S.C. 355a) (as amended by section 10) 
     is amended by adding at the end the following:
       ``(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)(D).
       ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
     section 505(j)(5)(D), 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 the 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)(D); or
       ``(D) except as expressly provided in paragraphs (1) and 
     (2), the operation of section 505.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     takes effect on the date of enactment of this Act, including 
     with respect to applications under section 505(j) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that 
     are approved or pending on that date.

     SEC. 12. STUDY CONCERNING RESEARCH INVOLVING CHILDREN.

       (a) Contract With Institute of Medicine.--The Secretary of 
     Health and Human Services shall enter into a contract with 
     the Institute of Medicine for--
       (1) the conduct, in accordance with subsection (b), of a 
     review of--
       (A) Federal regulations in effect on the date of the 
     enactment of this Act relating to research involving 
     children;
       (B) federally prepared or supported reports relating to 
     research involving children; and
       (C) federally supported evidence-based research involving 
     children; and
       (2) the submission to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, not later than 
     2 years after the date of enactment of this Act, of a report 
     concerning the review conducted under paragraph (1) that 
     includes recommendations on best practices relating to 
     research involving children.
       (b) Areas of Review.--In conducting the review under 
     subsection (a)(1), the Institute of Medicine shall consider 
     the following:
       (1) The written and oral process of obtaining and defining 
     ``assent'', ``permission'' and ``informed consent'' with 
     respect to child clinical research participants and the 
     parents, guardians, and the individuals who may serve as the 
     legally authorized representatives of such children (as 
     defined in subpart A of part 46 of title 45, Code of Federal 
     Regulations).
       (2) The expectations and comprehension of child research 
     participants and the parents, guardians, or legally 
     authorized representatives of such children, for the direct 
     benefits and risks of the child's research involvement, 
     particularly in terms of research versus therapeutic 
     treatment.
       (3) The definition of ``minimal risk'' with respect to a 
     healthy child or a child with an illness.
       (4) The appropriateness of the regulations applicable to 
     children of differing ages and maturity levels, including 
     regulations relating to legal status.
       (5) Whether payment (financial or otherwise) may be 
     provided to a child or his or her parent, guardian, or 
     legally authorized representative for the participation of 
     the child in research, and if so, the amount and type of 
     payment that may be made.
       (6) Compliance with the regulations referred to in 
     subsection (a)(1)(A), the monitoring of such compliance 
     (including the role of institutional review boards), and the 
     enforcement actions taken for violations of such regulations.
       (7) The unique roles and responsibilities of institutional 
     review boards in reviewing research involving children, 
     including composition of membership on institutional review 
     boards.
       (c) Requirements of Expertise.--The Institute of Medicine 
     shall conduct the review under subsection (a)(1) and make 
     recommendations under subsection (a)(2) in conjunction with 
     experts in pediatric medicine, pediatric research, and the 
     ethical conduct of research involving children.

     SEC. 13. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

       Section 499 of the Public Health Service Act (42 U.S.C. 
     290b) is amended--
       (1) in subsection (b), by inserting ``(including collection 
     of funds and awarding of grants for pediatric research and 
     studies on drugs)'' after ``mission'';
       (2) in subsection (c)(1)--
       (A) by redesignating subparagraph (C) as subparagraph (D); 
     and
       (B) by inserting after subparagraph (B) the following:
       ``(C) A program to collect funds and award grants for 
     pediatric research 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. 355a(d)(4)(C)).'';
       (3) in subsection (d)--
       (A) in paragraph (1)--
       (i) in subparagraph (B)--

       (I) in clause (ii), by striking ``and'' at the end;
       (II) in clause (iii), by striking the period and inserting 
     ``; and''; and
       (III) by adding at the end the following:

       ``(iv) the Commissioner of Food and Drugs.''; and
       (ii) by striking subparagraph (C) and inserting the 
     following:
       ``(C) The ex officio members of the Board under 
     subparagraph (B) shall appoint to the Board individuals from 
     among a list of candidates to be provided by the National 
     Academy of Science. Such appointed members shall include--
       ``(i) representatives of the general biomedical field;
       ``(ii) representatives of experts in pediatric medicine and 
     research;
       ``(iii) representatives of the general biobehavioral field, 
     which may include experts in biomedical ethics; and
       ``(iv) representatives of the general public, which may 
     include representatives of affected industries.''; and
       (B) in paragraph (2), by realigning the margin of 
     subparagraph (B) to align with subparagraph (A);
       (4) in subsection (k)(9)--
       (A) by striking ``The Foundation'' and inserting the 
     following:
       ``(A) In general.--The Foundation''; and
       (B) by adding at the end the following:
       ``(B) Gifts, grants, and other donations.--
       ``(i) In general.--Gifts, grants, and other donations to 
     the Foundation may be designated for pediatric research and 
     studies on drugs, and funds so designated shall be used 
     solely for grants for research and studies under subsection 
     (c)(1)(C). Other gifts, grants, or donations received by the 
     Foundation may also be used to support such pediatric 
     research and studies.
       ``(ii) Report.--The recipient of a grant for research and 
     studies shall agree to provide the Director of the National 
     Institutes of Health and the Commissioner of Food and Drugs, 
     at the conclusion of the research and studies--

       ``(I) a report describing the results of the research and 
     studies; and
       ``(II) all data generated in connection with the research 
     and studies.

[[Page 20310]]

       ``(iii) Action by the commissioner of food and drugs.--The 
     Commissioner of Food and Drugs shall take appropriate action 
     in response to a report received under clause (ii) in 
     accordance with section 409I(c)(7), including negotiating 
     with the holders of approved applications for the drugs 
     studied for any labeling changes that the Commissioner 
     determines to be appropriate and requests the holders to 
     make.
       ``(C) Applicability.--Subparagraph (A) does not apply to 
     the program described in subsection (c)(1)(C).'';
       (5) by redesignating subsections (f) through (m) as 
     subsections (e) through (l), respectively;
       (6) in subsection (h)(11) (as so redesignated), by striking 
     ``solicit'' and inserting ``solicit,''; and
       (7) in paragraphs (1) and (2) of subsection (j) (as so 
     redesignated), by striking ``(including those developed under 
     subsection (d)(2)(B)(i)(II))'' each place it appears.

     SEC. 14. PEDIATRIC ADVISORY COMMITTEE.

       (a) In General.--The Secretary of Health and Human Services 
     shall, under section 222 of the Public Health Service Act (42 
     U.S.C. 217a), convene and consult an advisory committee on 
     pediatrics (referred to in this section as the ``advisory 
     committee'').
       (b) Purpose.--
       (1) In general.--The advisory committee shall advise and 
     make recommendations to the Secretary, through the 
     Commissioner of Food and Drugs and in consultation with the 
     Director of the National Institute of Health, on all matters 
     relating to pediatrics, including pediatric therapeutics.
       (2) Matters included.--The matters referred to in paragraph 
     (1) include--
       (A) pediatric research conducted under sections 351, 409I, 
     and 499 of the Public Health Service Act and sections 501, 
     502, 505, and 505A of the Federal Food, Drug, and Cosmetic 
     Act;
       (B) identification of pediatric research priorities and the 
     need for additional treatments of specific pediatric diseases 
     or conditions; and
       (C) the ethics, design, and analysis of pediatric clinical 
     trials.
       (c) Composition.--The advisory committee shall include 
     representatives of pediatric health organizations, pediatric 
     researchers, relevant patient and patient-family 
     organizations, and other experts selected by the Secretary.
       (d) Clarification of Authorities.--
       (1) In general.--The Pediatric Subcommittee of the 
     Oncologic Drugs Advisory Committee (referred to in this 
     subsection as the ``Subcommittee''), in carrying out the 
     mission of reviewing and evaluating the data concerning the 
     safety and effectiveness of marketed and investigational 
     human drug products for use in the treatment of pediatric 
     cancers, shall--
       (A) evaluate and, to the extent practicable, prioritize new 
     and emerging therapeutic alternatives available to treat 
     pediatric cancer;
       (B) provide recommendations and guidance to help ensure 
     that children with cancer have timely access to the most 
     promising new cancer therapies; and
       (C) advise on ways to improve consistency in the 
     availability of new therapeutic agents.
       (2) Membership.--
       (A) In general.--The Secretary shall appoint at least 13 
     voting members to the Pediatric Subcommittee.
       (B) Request for participation.--The Subcommittee shall 
     request participation of the following members in the 
     scientific and ethical consideration of topics of pediatric 
     cancer, as necessary:
       (i) At least 2 pediatric oncology specialists from the 
     National Cancer Institute.
       (ii) At least 6 pediatric oncology specialists from--

       (I) the Children's Oncology Group;
       (II) other pediatric experts with an established history of 
     conducting clinical trials in children; or
       (III) consortia sponsored by the National Cancer Institute, 
     such as the Pediatric Brain Tumor Consortium, the New 
     Approaches to Neuroblastoma Therapy or other pediatric 
     oncology consortia.

       (iii) At least 2 representatives of the pediatric cancer 
     patient and patient-family community.
       (iv) 1 representative of the nursing community.
       (v) At least 1 statistician.
       (vi) At least 1 representative of the pharmaceutical 
     industry.
       (e) Pre-Clinical Models To Evaluate Promising Pediatric 
     Cancer Therapies.--Section 413 of the Public Health Service 
     Act (42 U.S.C. 285a-2) is amended by adding at the end the 
     following:
       ``(c) Pre-Clinical Models To Evaluate Promising Pediatric 
     Cancer Therapies.--
       ``(1) Expansion and coordination of activities.--The 
     Director of the National Cancer Institute shall expand, 
     intensify, and coordinate the activities of the Institute 
     with respect to research on the development of preclinical 
     models to evaluate which therapies are likely to be effective 
     for treating pediatric cancer.
       ``(2) Coordination with other institutes.--The Director of 
     the Institute shall coordinate the activities under paragraph 
     (1) with similar activities conducted by other national 
     research institutes and agencies of the National Institutes 
     of Health to the extent that those Institutes and agencies 
     have responsibilities that are related to pediatric 
     cancer.''.
       (f) Clarification of Availability of Investigational New 
     Drugs for Pediatric Study and Use.--
       (1) Amendment of the federal food, drug, and cosmetic 
     act.--Section 505(i)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(i)(1)) is amended--
       (A) in subparagraph (B), by striking ``and'' at the end;
       (B) in subparagraph (C), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following:
       ``(D) the submission to the Secretary by the manufacturer 
     or the sponsor of the investigation of a new drug of a 
     statement of intent regarding whether the manufacturer or 
     sponsor has plans for assessing pediatric safety and 
     efficacy.''.
       (2) Amendment of the public health service act.--Section 
     402(j)(3)(A) of the Public Health Service Act (42 U.S.C. 
     282(j)(3)(A)) is amended in the first sentence--
       (A) by striking ``trial sites, and'' and inserting ``trial 
     sites,''; and
       (B) by striking ``in the trial,'' and inserting ``in the 
     trial, and a description of whether, and through what 
     procedure, the manufacturer or sponsor of the investigation 
     of a new drug will respond to requests for protocol 
     exception, with appropriate safeguards, for single-patient 
     and expanded protocol use of the new drug, particularly in 
     children,''.
       (g) Report.--Not later than January 31, 2003, the Secretary 
     of Health and Human Services, acting through the Commissioner 
     of Food and Drugs and in consultation with the Director of 
     the National Institutes of Health, shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report on patient access to new 
     therapeutic agents for pediatric cancer, including access to 
     single patient use of new therapeutic agents.

     SEC. 15. REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM.

       (a) In General.--Not later than January 31, 2007, the 
     Secretary of Health and Human Services, in consultation with 
     the Comptroller General of the United States, shall submit to 
     Congress a report that addresses the following issues, using 
     publicly available data or data otherwise available to the 
     Government that may be used and disclosed under applicable 
     law:
       (1) The effectiveness of this Act and the amendments made 
     by this Act in ensuring that medicines used by children are 
     tested and properly labeled, including--
       (A) the number and importance of drugs for children that 
     are being tested as a result of this legislation and the 
     importance for children, health care providers, parents, and 
     others of labeling changes made as a result of such testing;
       (B) the number and importance of drugs for children that 
     are not being tested for their use notwithstanding the 
     provisions of this legislation, and possible reasons for the 
     lack of testing; and
       (C) the number of drugs for which testing is being done, 
     exclusivity granted, and labeling changes required, including 
     the date pediatric exclusivity is granted and the date 
     labeling changes are made (noting whether or not labeling 
     changes were requested by the Food and Drug Administration 
     and what, if any, recommendation was made by the Pediatric 
     Advisory Committee).
       (2) The economic impact of this Act and the amendments made 
     by this Act, including an estimate of--
       (A) the costs to taxpayers in the form of higher 
     expenditures by medicaid and other Government programs;
       (B) increased sales for each drug during the 6-month period 
     for which exclusivity is granted;
       (C) costs to consumers and private insurers as a result of 
     any delay in the availability of lower cost generic 
     equivalents of drugs tested and granted exclusivity under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
     and loss of revenue by the generic drug industry as a result 
     of any such delay; and
       (D) savings to taxpayers (in the form of lower expenditures 
     by medicaid and other Government programs), private insurers, 
     and consumers due to more appropriate and more effective use 
     of medications in children as a result of testing and 
     relabeling, including savings from fewer hospitalizations and 
     fewer medical errors.
       (3) The nature and type of studies in children for each 
     drug granted exclusivity under the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.), including--
       (A) a description of the complexity of the studies;
       (B) the number of study sites necessary to obtain 
     appropriate data;
       (C) the numbers of children involved in any clinical 
     studies; and
       (D) the estimated cost of each of the studies.
       (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

[[Page 20311]]

     the Public Health Service Act this Act (as added by section 
     3) that the Secretary determines to be appropriate, including 
     a detailed rationale for each recommendation.
       (5) The increased private and Government-funded pediatric 
     research capability associated with this Act and the 
     amendments made by this Act.
       (6) The number of written requests and additional letters 
     of recommendation that the Secretary issues.
       (7) The prioritized list of off-patent drugs for which the 
     Secretary issues written requests.
       (8)(A) The efforts made by 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 studies ethical and safe.
       (b) Timing.--
       (1) Report on methodology.--Not later than January 31, 
     2004, the Secretary shall submit to Congress a report 
     explaining the methodology that the Secretary intends to use 
     to prepare the report under subsection (a).
       (2) Interim reports.--Before submission of a final report 
     under subsection (a), the Secretary shall periodically make 
     publicly available information on the matters described in 
     paragraphs (1), (3), (6), and (7) of subsection (a).

     SEC. 16. TECHNICAL AND CONFORMING AMENDMENTS.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) (as amended by sections 2(1), 5(b)(2), 9, 
     10, and (11)) is amended--
       (1)(A) by striking ``(j)(4)(D)(ii)'' each place it appears 
     and inserting ``(j)(5)(D)(ii)'';
       (B) by striking ``(j)(4)(D)'' each place it appears and 
     inserting ``(j)(5)(D)''; and
       (C) by striking ``505(j)(4)(D)'' each place it appears and 
     inserting ``505(j)(5)(D)'';
       (2) by redesignating subsections (a), (g), (h), (i), (j), 
     (k), (l), (m), (n), and (o) as subsections (b), (a), (g), 
     (h), (n), (m), (i), (j), (k), and (l) respectively;
       (3) by moving the subsections so as to appear in 
     alphabetical order;
       (4) in paragraphs (1), (2), and (3) of subsection (d), 
     subsection (e), and subsection (m) (as redesignated by 
     paragraph (2)), by striking ``subsection (a) or (c)'' and 
     inserting ``subsection (b) or (c)''; and
       (5) in subsection (g) (as redesignated by paragraph (2)), 
     by striking ``subsection (a) or (b)'' and inserting 
     ``subsection (b) or (c)''.
                                  ____

  SA 1906. Mr. HATCH submitted an amendment intended to be proposed by 
him to the bill S. 838, to amend the Federal Food, Drug, and Cosmetic 
Act to improve the safety and efficacy of pharmaceuticals for children; 
which was ordered to lie on the table; as follows:

       Amend section 10 to read as follows:
       ``(n)(1)(B). If the 180-day period would, but for this 
     subsection, expire after the 6-month extension, by the period 
     of overlap.''
       ``(n)(2). Under no circumstances shall application of this 
     section result in an applicant for approval of a drug under 
     section 505(j) being entitled to an exclusivity period that 
     (aside from the 6-month pediatric exclusivity period) 
     prohibits the approval of a subsequent application under 
     505(j) for more than 180 days.''
  SA 1907. Mr. REID (for Mr. Durbin) proposed an amendment to the 
concurrent resolution S. Con. Res. 74, condemning bigotry and violence 
against Sikh-Americans in the wake of terrorist attacks in New York 
City and Washington, D.C. on September 11, 2001; as follows:

       Strike all after the resolving clause and insert the 
     following:
       That Congress--
       (1) declares that, in the quest to identify, locate, and 
     bring to justice the perpetrators and sponsors of the 
     terrorist attacks on the United States on September 11, 2001, 
     the civil rights and civil liberties of all Americans, 
     including Sikh-Americans, should be protected;
       (2) condemns bigotry and any acts of violence or 
     discrimination against any Americans, including Sikh-
     Americans;
       (3) calls upon local and Federal law enforcement 
     authorities to work to prevent crimes against all Americans, 
     including Sikh-Americans; and
       (4) calls upon local and Federal law enforcement 
     authorities to prosecute to the fullest extent of the law all 
     those who commit crimes.
                                  ____

  SA 1908. Mr. REID (for Mr. Durbin) proposed an amendment to the 
concurrent resolution S. Con. Res. 74, condemning bigotry and violence 
against Sikh-Americans in the wake of terrorist attacks in New York 
City and Washington, D.C. on September 11, 2001; as follows:

       Strike the preamble and insert the following:
       ``Whereas all Americans are united in condemning, in the 
     strongest possible terms, the terrorists who planned and 
     carried out the attacks against the United States on 
     September 11, 2001, and in pursuing all those responsible for 
     those attacks and their sponsors until they are brought to 
     justice;
       ``Whereas Sikh-Americans form a vibrant, peaceful, and law-
     abiding part of America's people;
       ``Whereas approximately 500,000 Sikhs reside in the United 
     States and are a vital part of the Nation;
       ``Whereas Sikh-Americans stand resolutely in support of the 
     commitment of our Government to bring the terrorists and 
     those that harbor them to justice;
       ``Whereas the Sikh faith is a distinct religion with a 
     distinct religious and ethnic identity that has its own 
     places of worship and a distinct holy text and religious 
     tenets;
       ``Whereas many Sikh-Americans, who are easily recognizable 
     by their turbans and beards, which are required articles of 
     their faith, have suffered both verbal and physical assaults 
     as a result of misguided anger toward Arab-Americans and 
     Muslim-Americans in the wake of the September 11, 2001 
     terrorist attack;
       ``Whereas Sikh-Americans, as do all Americans, condemn acts 
     of hate and prejudice against any American; and
       ``Whereas Congress is seriously concerned by the number of 
     crimes against Sikh-Americans and other Americans all across 
     the Nation that have been reported in the wake of the tragic 
     events that unfolded on September 11, 2001: Now, therefore, 
     be it''.

                          ____________________