[Congressional Record (Bound Edition), Volume 147 (2001), Part 19]
[House]
[Pages 26420-26433]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

  Mr. TAUZIN. Mr. Speaker, I move to suspend the rules and pass the 
Senate bill (S. 1789) to amend the Federal Food, Drug, and Cosmetic Act 
to improve the safety and efficacy of pharmaceuticals for children.
  The Clerk read as follows:

                                S. 1789

       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 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.

       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

[[Page 26421]]

     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 written request shall be made in a manner equivalent to the 
     manner in which a written request is made under subsection 
     (a) or (b) of section 505A of the Federal Food, Drug, and 
     Cosmetic Act, including with respect to information provided 
     on the pediatric studies to be conducted pursuant to the 
     request.
       ``(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 subcommittee of the 
     anti-infective drugs advisory committee.--If, not later than 
     the end of the 180-day period specified in paragraph (7), the 
     holder of an approved application for the drug involved does 
     not agree to any labeling change requested by the 
     Commissioner of Food and Drugs under that paragraph, the 
     Commissioner of Food and Drugs shall refer the request to the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee.
       ``(B) Action by the pediatric advisory subcommittee of the 
     anti-infective drugs advisory committee.--Not later than 90 
     days after receiving a referral under subparagraph (A), the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     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 
     Subcommittee of the Anti-Infective Drugs 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 the Federal Food, Drug, and Cosmetic 
     Act when a drug lacks appropriate pediatric labeling. Neither 
     course of action (the Pediatric Advisory Subcommittee of the 
     Anti-Infective Drugs Advisory Committee process or an 
     enforcement action referred to in the preceding sentence) 
     shall preclude, delay, or serve as the basis to stay the 
     other course of action.
       ``(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.--
       ``(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

[[Page 26422]]

     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 
     under section 499(j)(9)(B)(i) 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) 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 shall refer the matter to the Pediatric Advisory 
     Subcommittee of the Anti-Infective Drugs Advisory Committee.
       ``(B) Action by the pediatric advisory subcommittee of the 
     anti-infective drugs advisory committee.--Not later than 90 
     days after receiving a referral under subparagraph (A)(ii), 
     the Pediatric Advisory Subcommittee of the Anti-Infective 
     Drugs 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 
     Subcommittee of the Anti-Infective Drugs Advisory Committee 
     and, if appropriate, not later than 30 days after receiving 
     the recommendation, make a request to the sponsor of the 
     application to make any labeling change that the Commissioner 
     determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application, 
     within 30 days after receiving a request under subparagraph 
     (C), does not agree to make a labeling change requested by 
     the Commissioner, the Commissioner may deem the drug that is 
     the subject of the application to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee process or an enforcement action referred 
     to in the preceding sentence) shall preclude, delay, or serve 
     as the basis to stay the other course of action.''.

     SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

       (a) Establishment.--The Secretary of Health and Human 
     Services shall establish an Office of Pediatric Therapeutics 
     within the Food and Drug Administration.
       (b) Duties.--The Office of Pediatric Therapeutics shall be 
     responsible for coordination and facilitation 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 coordinate with employees of the 
     Department of Health and Human Services who exercise 
     responsibilities relating to pediatric therapeutics and shall 
     include--
       (1) 1 or more additional individuals with expertise 
     concerning ethical issues presented by the conduct of 
     clinical research in the pediatric population; and
       (2) 1 or more additional individuals with expertise in 
     pediatrics as may be necessary to perform the 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 accepted for filing under section 505(b); 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.''.

     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).--If a 
     180-day period under section 505(j)(5)(B)(iv) overlaps with a 
     6-month exclusivity period under this section, so that the 
     applicant for approval of a drug under section 505(j) 
     entitled to the 180-day period under that section loses a 
     portion of the 180-day period to which the applicant is 
     entitled for the drug, the 180-day period shall be extended 
     from--
       ``(1) the date on which the 180-day period would have 
     expired by the number of days of the overlap, if the 180-day 
     period would, but for the application of this subsection, 
     expire after the 6-month exclusivity period; or
       ``(2) the date on which the 6-month exclusivity period 
     expires, by the number of days of the overlap if the 180-day 
     period would, but for the application of this subsection, 
     expire during the 6 month exclusivity period.''.

[[Page 26423]]



     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 a manufacturer--
       ``(i) the drug is not labeled for pediatric use; or
       ``(ii) in the case of a drug for which there is an 
     additional pediatric use not referred to in paragraph (1), 
     the drug is not labeled for the pediatric use under paragraph 
     (1); and
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, or precautions that the 
     Secretary considers necessary.
       ``(3) Preservation of pediatric exclusivity and other 
     provisions.--This subsection does not affect--
       ``(A) the availability or scope of exclusivity under this 
     section;
       ``(B) the availability or scope of exclusivity under 
     section 505 for pediatric formulations;
       ``(C) the question of the eligibility for approval of any 
     application under section 505(j) that omits any other 
     conditions of approval entitled to exclusivity under clause 
     (iii) or (iv) of section 505(j)(5)(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 for pediatric pharmacologic research)'' 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 for pediatric 
     pharmacologic 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).
       ``(ii) Other gifts.--Other gifts, grants, or donations 
     received by the Foundation and not described in clause (i) 
     may also be used to support such pediatric research and 
     studies.
       ``(iii) 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.

       ``(iv) 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 (iii) in 
     accordance with paragraphs (7) through (12) of section 
     409I(c), 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 PHARMACOLOGY 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 
     pediatric pharmacology (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 Institutes of Health, on matters 
     relating to pediatric pharmacology.

[[Page 26424]]

       (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 research priorities related to 
     pediatric pharmacology and the need for additional treatments 
     of specific pediatric diseases or conditions; and
       (C) the ethics, design, and analysis of clinical trials 
     related to pediatric pharmacology.
       (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.

     SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS 
                   ADVISORY COMMITTEE.

       (a) Clarification of Authorities.--
       (1) In general.--The Pediatric Subcommittee of the 
     Oncologic Drugs Advisory Committee (referred to in this 
     section 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 not more than 
     11 voting members to the Pediatric Subcommittee from the 
     membership of the Pediatric Pharmacology Advisory Committee 
     and the Oncologic Drugs Advisory Committee.
       (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 4 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.
       (b) 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.''.
       (c) 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,''.
       (d) 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. 16. REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM.

       Not later than October 1, 2006, 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 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 section 505A of the Federal Food, 
     Drug, and Cosmetic Act and section 409I of the Public Health 
     Service Act (as added 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 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 Subcommittee of the Anti-Infective Drugs 
     Advisory Committee.
       (2) The economic impact of section 505A of the Federal 
     Food, Drug, and Cosmetic Act and section 409I of the Public 
     Health Service Act (as added 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) sales for each drug during the 6-month period for which 
     exclusivity is granted, as attributable to such exclusivity;
       (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 and retail 
     pharmacies as a result of any such delay; and
       (D) the benefits to the government, to private insurers, 
     and to consumers resulting from decreased health care costs, 
     including--
       (i) decreased hospitalizations and fewer medical errors, 
     due to more appropriate and more effective use of medications 
     in children as a result of testing and re-labeling because of 
     the amendments made by this Act;
       (ii) direct and indirect benefits associated with fewer 
     physician visits not related to hospitalization;
       (iii) benefits to children from missing less time at school 
     and being less affected by chronic illnesses, thereby 
     allowing a better quality of life;
       (iv) benefits to consumers from lower health insurance 
     premiums due to lower treatment costs and hospitalization 
     rates; and
       (v) benefits to employers from reduced need for employees 
     to care for family members.
       (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 the Public 
     Health Service 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.

[[Page 26425]]

       (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.

     SEC. 17. ADVERSE-EVENT REPORTING.

       (a) Toll-Free Number in Labeling.--Not later than one year 
     after the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall promulgate a final rule 
     requiring that the labeling of each drug for which an 
     application is approved under section 505 of the Federal 
     Food, Drug, and Cosmetic Act (regardless of the date on which 
     approved) include the toll-free number maintained by the 
     Secretary for the purpose of receiving reports of adverse 
     events regarding drugs and a statement that such number is to 
     be used for reporting purposes only, not to receive medical 
     advice. With respect to the final rule:
       (1) The rule shall provide for the implementation of such 
     labeling requirement in a manner that the Secretary considers 
     to be most likely to reach the broadest consumer audience.
       (2) In promulgating the rule, the Secretary shall seek to 
     minimize the cost of the rule on the pharmacy profession.
       (3) The rule shall take effect not later than 60 days after 
     the date on which the rule is promulgated.
       (b) Drugs With Pediatric Market Exclusivity.--
       (1) In general.--During the one-year beginning on the date 
     on which a drug receives a period of market exclusivity under 
     505A of the Federal Food, Drug, and Cosmetic Act, any report 
     of an adverse event regarding the drug that the Secretary of 
     Health and Human Services receives shall be referred to the 
     Office of Pediatric Therapeutics established under section 6 
     of this Act. In considering the report, the Director of such 
     Office shall provide for the review of the report by the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee, including obtaining any recommendations 
     of such Subcommittee regarding whether the Secretary should 
     take action under the Federal Food, Drug, and Cosmetic Act in 
     response to the report.
       (2) Rule of construction.--Paragraph (1) may not be 
     construed as restricting the authority of the Secretary of 
     Health and Human Services to continue carrying out the 
     activities described in such paragraph regarding a drug after 
     the one-year period described in such paragraph regarding the 
     drug has expired.

     SEC. 18. MINORITY CHILDREN AND PEDIATRIC-EXCLUSIVITY PROGRAM.

       (a) Protocols for Pediatric Studies.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended in subsection (d)(2) by inserting after the first 
     sentence the following: ``In reaching an agreement regarding 
     written protocols, the Secretary shall take into account 
     adequate representation of children of ethnic and racial 
     minorities.''.
       (b) Study by General Accounting Office.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study for the purpose of determining 
     the following:
       (A) The extent to which children of ethnic and racial 
     minorities are adequately represented in studies under 
     section 505A of the Federal Food, Drug, and Cosmetic Act; and 
     to the extent ethnic and racial minorities are not adequately 
     represented, the reasons for such under representation and 
     recommendations to increase such representation.
       (B) Whether the Food and Drug Administration has 
     appropriate management systems to monitor the representation 
     of the children of ethnic and racial minorities in such 
     studies.
       (C) Whether drugs used to address diseases that 
     disproportionately affect racial and ethnic minorities are 
     being studied for their safety and effectiveness under 
     section 505A of the Federal Food, Drug, and Cosmetic Act.
       (2) Date certain for completing study.--Not later than 
     January 10, 2003, the Comptroller General shall complete the 
     study required in paragraph (1) and submit to the Congress a 
     report describing the findings of the study.

     SEC. 19. 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, 11, and 17) 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)''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Louisiana (Mr. Tauzin) and the gentleman from Ohio (Mr. Brown) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).


                             General Leave

  Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
and include extraneous material on S. 1789.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Louisiana?
  There was no objection.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in strong support of S. 1789, the Best 
Pharmaceuticals for Children Act. I wish to commend the hard work of 
the House sponsors of this legislation, the gentleman from Pennsylvania 
(Mr. Greenwood) and the gentlewoman from California (Ms. Eshoo), two 
extraordinarily valuable members of the Committee on Energy and 
Commerce, and urge swift passage of this bipartisan bill.
  The bill before us today represents a product of bipartisan and 
bicameral negotiation. This is strikingly similar to the legislation 
that already passed this House on November 15 by a vote of 338 to 86. 
Because the bill passed by the other body differed slightly from the 
House-passed bills, the bills had to be reconciled. S. 1789 is a 
product of those negotiations. The Senate recently approved the bill 
without a single dissenting vote.
  For years, drugs used in children were not tested for children. To 
address this situation, the gentleman from Pennsylvania (Mr. Greenwood) 
and the gentleman from California (Mr. Waxman) worked together in 1997 
to provide manufacturers with an incentive to test these drugs 
specifically for children. The incentive adopted then was an additional 
6 months of exclusivity under the patents added to the existing 
exclusivity of patent protection for testing these drugs at the request 
of the FDA.
  The incentive has worked extraordinarily well. According to the FDA: 
``The pediatric exclusivity provision has done more to generate 
clinical studies and useful prescribing information for the pediatric 
population than any other regulatory or legislative process to date.'' 
According to the American Academy of Pediatrics, the incentive ``has 
advanced therapeutics for infants, children and adolescents, in a way 
that has not been possible in several decades prior to the passage of 
this law.''
  Every children's group in America supports this reauthorization. This 
is why the Committee on Energy and Commerce reported the bill by a 
strong bipartisan vote of 41 to 6. The differences between the bill 
that passed the Committee on Energy and Commerce and the bill before us 
today are minimal. The main difference is that the Greenwood-Eshoo 
regulation created a new Foundation for Pediatric Research, while S. 
1789 subsumes that foundation within the existing NIH Foundation.
  A few Members may oppose the reauthorization by saying that pediatric 
exclusivity has provided a windfall to industry and increased costs to 
consumers. Well, truth be told, while some companies have indeed 
benefited financially for testing their drugs in children, the GAO 
notes that ``while there has been some concern that exclusivity may be 
sought and granted primarily for drugs that generate substantial 
revenue, most of the drugs studied are not top sellers.'' In fact, 20 
of the 37 drugs which have been granted exclusivity fall outside the 
top 200 in terms of drug-sale revenues. Further, the FDA estimates that 
the cost of this provision adds about one-half of one percent to the 
Nation's pharmaceutical bill.
  Importantly, because the FDA has failed to act, this legislation 
contains a

[[Page 26426]]

provision which will result in generic drugs being approved when their 
labeling omits the pediatric indication or other aspect of labeling 
which is protected by the patent exclusivity.
  While one drug has been prominently mentioned in this debate, the FDA 
has informed the committee that a number of drugs have received 3 years 
of additional exclusivity for pediatric use under Hatch-Waxman. It is 
my strong belief that in implementing this provision, the Secretary 
will apply it comprehensively and uniformly to all affected drugs; and 
to ensure that all interested parties have their voices heard, the 
Secretary should provide for public notice and comment in implementing 
this important provision.
  Pediatric exclusivity has resulted in drugs which are used in 
children being tested on children and for children; and due to this 
law, drug labels are being changed to contain pediatric labeling. Now, 
because of the work of the gentleman from Pennsylvania (Mr. Greenwood) 
and the gentlewoman from California (Ms. Eshoo), the law will also 
ensure that generic drugs used in children will also have their labels 
changed.
  The American Academy of Pediatrics, the Coalition for Children's 
Health, the National Association of Children's Hospitals, and the 
Elizabeth Glaser Pediatric AIDS Foundation are all telling us to pass 
the Greenwood-Eshoo legislation now. If this program is not 
reauthorized this year, it expires. Do not be in a position of having 
to explain to your children's hospitals or to the Academy of Pediatrics 
and the Pediatric AIDS Foundation why you killed their top priority.
  My recommendation to this House is to vote yes on this worthy bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 6 minutes.
  Mr. Speaker, unfortunately, the legislation we are considering today, 
named the Best Pharmaceuticals for Children Act, is not about children; 
it is about money. It is about the most influential industry on Capitol 
Hill co-opting an emotional issue to lock in another 5 years of 
unjustifiable, unearned revenues.
  It is about reauthorizing a program that pays drug companies 
literally tens of billions of dollars, straight out of the pockets of 
consumers who will pay higher prices, for tests that cost relatively 
only a few million dollars to conduct. Again, it is about reauthorizing 
a program that pays drug companies tens of billions of dollars in 
higher prices for consumers for tests that cost a few million dollars 
to conduct.
  No one disputes the need for pediatric drug testing. In a health care 
system as advanced as ours, it is unfathomable that our children are 
still being prescribed medicines on a hit-or-miss basis. But this bill 
does not ensure that medicines are first tested for use in children 
before they are sold for that purpose. It does not ensure that 
prescription drugs already on the market, already being used in 
children, are tested.
  If we pass this legislation, we are guaranteeing one thing and one 
thing only: we are guaranteeing consumers an additional 6 months of 
grossly inflated prices for some of the most widely used prescription 
drugs on the market.
  Five years ago, Mr. Speaker, Congress passed legislation offering 6 
months of market exclusivity to drug companies if they conduct 
pediatric tests. Five years later, we know that the cost to consumers 
of this 6-month provision is astronomical, while the cost of testing is 
minimal. We could pay drug companies twice the cost of testing, three 
times the cost of testing, even four times the cost of testing. We 
would still save a fortune on behalf of consumers.

                              {time}  1545

  For drugs like Prilosec and Prozac and Zocor and Neurontin, the 
exclusivity provisions add $50 to $70 for every prescription that every 
American gets. Again, it is maybe 2 percent industry-wide, as the 
gentleman from Louisiana mentions, but these provisions, for those 
drugs, Prilosec, Prozac, Zocor, Neurontin, add $50 to $70 for each 
prescription. For those of us who have constituents that take Prilosec 
and Prozac and Zocor and Neurontin, a ``yes'' vote will mean they will 
pay, every time, $50 to $70 more for each prescription.
  The manufacturer of these drugs will take home an additional $500 
million to $1.6 billion for conducting tests that cost about $4 million 
each. Quite a return on their investment, Mr. Speaker.
  I hoped committee deliberations on this legislation would have 
produced some legitimate arguments and reasonable justification for 
extending this 6-month exclusivity provision, but it did not happen. 
Proponents argue that we should sustain this program because, they say, 
6 months exclusivity works. Giving the drug industry the keys to the 
Federal Treasury would also work. Does that mean it is a good idea? 
They say pediatric exclusivity is the most successful program ever when 
it comes to increasing the number of pediatric tests. It is also the 
only incentive program that Congress has ever tried. Previous attempts 
relied on subtle persuasion, not rewards, not mandates, not any kinds 
of big money incentives as this gets.
  Proponents say pediatric exclusivity uses marketplace incentives. It 
is a ``free market'' solution, they tell us. Pediatric exclusivity is 
not a free market solution, and it does not use marketplace incentives. 
In free markets, competition and demand drive behavior. When it comes 
to pediatric exclusivity, the prospect that the Federal Government will 
step in and block generic competition is what drives behavior. 
Monopolies are anathema to free markets.
  Proponents say that when we factor in lower children's health care 
costs, pediatric exclusivity actually saves money. I wonder if the 
authors of this research factored in the health care costs that accrue 
when seniors who cannot afford this $50 or $70 increase, as this bill 
allows, who cannot afford these prescriptions, I wonder what happens 
when they remain ill, when children whose parents cannot afford 
inflated drug prices remain ill.
  Why do I oppose this legislation? Simply because Congress did not 
give serious consideration to less costly alternatives. Because this 
bill, frankly, Mr. Speaker, uses children as bait to capture another 
windfall for the drug industry. It uses children as bait to capture 
another windfall for the drug industry. I oppose this bill because it 
promotes bad policy and consumers throughout the country will pay for 
it.
  Before closing, Mr. Speaker, I want to speak for a moment about a 
provision in this legislation that is in the public's best interests. 
It is the clarification amendments set forth in section 10, which is 
intended to make absolutely sure that an important incentive for 
generic competition is, in fact, preserved. This section clarifies that 
the grant of pediatric exclusivity does not diminish the generic 
exclusivity period awarded to the first genetic firm to file a 
paragraph IV certification. Obviously, this clarifying amendment 
applies to pediatric exclusivity periods that have already been granted 
as well as those that will be granted in the future. That good language 
in section 10 of the bill notwithstanding, Mr. Speaker, this is bad 
legislation. We should vote ``no.''
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I am pleased to yield 3\1/2\ minutes to the 
distinguished gentleman from Indiana (Mr. Burton), the distinguished 
chairman of the Committee on Government Reform.
  Mr. BURTON of Indiana. Mr. Speaker, I thank the gentleman for 
yielding me this time.
  I think this is probably a very good bill and I support it. However, 
there are a few things I would like to say to the members of the 
Committee on Energy and Commerce, because I think it is very important, 
and I have not had an opportunity to do it before.
  One of the things that is not widely known is many of the children's 
vaccinations contain a substance called thimerosal, and thimerosal is a 
substance that is put in there as a preservative when they put many 
vaccinations

[[Page 26427]]

in one vial. Thimerosal contains Mercury. Mercury is a toxic substance 
that should not be put in anybody's body, let alone children. Children 
get as many as 25 to 30 vaccinations by the time they go to school. 
Children get sometimes as much as 45 to 50 times the amount of Mercury 
in their systems that is tolerable in an adult and, as a result, many 
children suffer mental disorders because of this, according to some 
leading scientists.
  The number of children in America that are autistic has gone from 1 
in 10,000 to 1 in 500. We have an absolute epidemic of autism in this 
country. Many scientists around the world believe one of the major 
contributing factors is these toxic substances that are being used as 
preservatives in these vaccinations; in particular, mercury.
  Now, we have taken mercury out of all topical dressings. One cannot 
get a topical dressing now that has mercury in it, and yet there are a 
lot of substances such as eye drops, vaccinations and a whole host of 
things that contain mercury. I have talked to the FDA. We have had them 
before my committee many times. Two years ago we talked to them about 
the DPT shot. We asked them about mercury and we asked them about the 
other shots that have mercury in them, and they said they were going to 
try to get that substance out. They have not done so. I think it is, in 
large part, because many of the pharmaceutical companies want to use 
this because it does help enhance profits. But mercury should not be 
injected into any child.
  I would like to say to my colleagues who are maybe here in the 
Chamber or back in their offices, and I hope the chairman will listen 
to this, because we have been told that we should all get a flu shot 
because of the anthrax scare. Do Members know that the flu shots that 
we are getting at the doctor's office here in the Capitol contain 
mercury? Many scientists believe that mercury is a contributing factor 
to Alzheimer's as well as other children's diseases like autism.
  So I would just like to say to the chairman, I hope he will consider 
holding hearings as we have in our committee, because his committee is 
the committee of jurisdiction, to force the FDA to get toxic substances 
like mercury out of those vaccinations for children and adults, because 
it is not necessary. If they go to single shot vials, they do not need 
that in there. But they put 10 shots in one vial, and because they put 
the needle continually in there, they say they need to have mercury in 
there as a preservative.
  For the sake of our children, 1 in 500, in some parts of the country 
it is 1 in 180 are autistic now, it is an absolute epidemic, I suggest 
that anything that might be a contributing factor ought to be 
extricated from these vaccinations, and I hope the gentleman from 
Louisiana (Mr. Tauzin) and the gentleman from Pennsylvania (Mr. 
Greenwood) will take a look at this problem.
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. BURTON of Indiana. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. Mr. Speaker, I certainly want to thank the chairman and 
ensure him that our committee is anxious to work with his Committee on 
Government Reform. If he will be kind enough to share the documentation 
and the results of his hearings with our committee, we will be more 
than happy to work with him.
  Mr. BURTON of Indiana. Mr. Speaker, I thank the gentleman, and we 
will have it to him right away.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume to comment on the comments of the gentleman from Indiana (Mr. 
Burton) about mercury and to thank him for raising the call about 
mercury. It is a substance banned in almost every country in the world 
and I appreciate the work that he has done in raising the public 
knowledge of that toxic substance.
  Mr. Speaker, I yield 2\1/2\ minutes to the gentlewoman from 
California (Ms. Harman), a member of the Committee on Commerce.
  Ms. HARMAN. Mr. Speaker, I thank the gentleman for yielding me this 
time, and also say that though I support this legislation, I very much 
respect his views and his leadership on competition issues.
  Mr. Speaker, I want to alert this body that one of the principal 
sponsors of this legislation, the gentlewoman from California (Ms. 
Eshoo), is on her way in from the airport. Sadly, she may miss this 
debate. I stand here to salute her leadership on this issue, along with 
the gentleman from Pennsylvania (Mr. Greenwood), and to say that even 
if she does miss this debate, she will not miss the fact that through 
her contribution, we today will overwhelmingly, I predict, pass this 
legislation.
  Notwithstanding the importance of competition, Mr. Speaker, this 
legislation is about harnessing the promise of the most advanced 
pharmaceuticals for the most vulnerable members of our society, our 
children. Dr. Jay Lieberman, a pediatric disease specialist from my 
district, has told me that literally every day he sees children with 
serious, sometimes life-threatening infections on whom he must use the 
antibiotics and other drugs that have not been tested to determine how 
safe they are for kids.
  We must do all we can to end this lack of knowledge, and the 
extension of patent exclusivity for companies that test their 
pharmaceuticals for children is the proven way to help kids. Over the 
past 4 years, pharmaceutical companies have dramatically increased the 
number of pediatric trials for new prescription drugs. More products 
are being labeled with proper dosage for children and potentially 
harmful interactions, and more companies are conducting research into 
special drug formulations for children.
  What we are doing today, Mr. Speaker, is not enacting a new law; we 
are renewing good law that has brought about better treatments for 
children. We also clarify that drug companies cannot draw more than 6 
months exclusivity for conducting pediatric trials. We must do all we 
can to improve the safety of pharmaceuticals for kids. This bill is the 
narrowest way to do this, consistent with protecting competition and 
consistent with assuring that drug companies already doing this work 
will continue to do it.
  I want to salute the bipartisan sponsorship of the bill, our 
chairman, the gentleman from Louisiana (Mr. Tauzin) who is standing 
here and the gentleman from Pennsylvania (Mr. Greenwood), and to say 
that the gentlewoman from California (Ms. Eshoo), were she here, would 
be saying the same things. I thank the chairman for his leadership. I 
urge passage of this bill.
  Mr. TAUZIN. Mr. Speaker, I yield myself 30 seconds, first of all, to 
thank the gentlewoman from California (Ms. Harman) and particularly the 
gentlewoman from California (Ms. Eshoo) who could not be here today for 
her handling of the bill and for her excellent work with the gentleman 
from Pennsylvania (Mr. Greenwood) on this legislation.
  Finally, I would mention that while there are some costs to this 
exclusivity, Tufts University has estimated that while it costs 
Americans about $700 million for this 6 months of extra exclusivity, 
that we gain $7 billion of savings each year in medical costs for 
children. It is a 10 to 1 savings. That is worth doing.
  Mr. Speaker, I am pleased to yield 3 minutes to the gentleman from 
Pennsylvania (Mr. Greenwood), the chairman of the Subcommittee on 
Oversight and Investigations of the Committee on Commerce and the 
author of the legislation.
  Mr. GREENWOOD. Mr. Speaker, I thank the gentleman from Louisiana (Mr. 
Tauzin), the chairman of the full committee for yielding me this time 
and I also thank him for his support throughout this progress on this 
important piece of legislation.
  Mr. Speaker, this bill, as has been mentioned by the chairman, passed 
just about a month ago by the overwhelming margin of 338 to 86 in this 
House and, in fact, it passed in the Senate unanimously. So today we 
pass the Senate version of this bill so we can get it to the President 
so we can continue to provide these health benefits for children. It 
passed by that overwhelming majority because there is

[[Page 26428]]

wide agreement on just about every facet of this issue. There is 
universal agreement, no one debates the question, that for decades; in 
fact, for all of the health history of this country, we have had a 
serious problem in trying to get pharmaceutical companies to test their 
products on children so that pediatricians and other doctors and 
specialists can prescribe these medications in ways that benefit 
children particularly and take into consideration of the different 
physiology and the different size and weight of children. Everyone 
agrees to that.
  Everyone agrees that since 1997 when we enacted this Better 
Pharmaceuticals for Children bill, there has been a dramatic and 
unanticipated flurry of these studies, about 400 of them, which the 
pediatric community and all of these organizations, the American 
Academy of Pediatrics, the National Association of Children's 
Hospitals, the Elizabeth Glazier Pediatric AIDS Foundation, the March 
of Dimes, the American Academy of Child and Adolescent Psychiatry, and 
on and on, all of these groups universally acknowledge and agree that 
this has been a saviour in providing good medical information to 
physicians.
  There has been one area of dispute, and that area of dispute is what 
is the proper incentive to give the pharmaceutical companies in order 
to get them to provide these studies. What we say in the bill is if the 
Food and Drug Administration, the FDA, asks a pharmaceutical company, 
please provide clinical trials for children for your product, and the 
company does that study, and we have that information available, we 
have a clean, simple, neat incentive, and that is, you will gain 6 
months of additional exclusivity; when the 6 months is over, in comes 
generic competition and the prices go down.
  Now the opponents of this bill have suggested a series of rather Rube 
Goldberg complicated, unworkable and unfair alternatives to this plan.

                              {time}  1600

  We have looked at them; and overwhelmingly, the Food and Drug 
Administration has said to us, we do not want to get involved in those 
kinds of complicated schemes that are unworkable and unmanageable for 
us.
  What we have is working; it is working well. Let us not fix something 
that is not broken. Let us not quarrel with success. Let us provide 
another overwhelming vote in support of this legislation for children.
  Today, Mr. Speaker, I am happy that the House is considering S. 1789, 
the Best Pharmaceuticals for Children Act.
  This bill is the essence of bipartisan policy. It originally passed 
the House by a vote of 338-86 on November 15, and the Senate passed it 
by unanimous consent yesterday.
  Chairman Tauzin, and Chairman Bilirakis, thank you for your 
leadership and hard work in moving this bill from committee to the 
floor and for achieving a unified bill with the Senate.
  Mr. Speaker, I am also pleased to have worked with Ms. Eshoo and the 
16 other members of the minority who have cosponsored this legislation.
  Mr. Speaker, this is public policy at its best. Over 400 studies are 
currently underway to fulfill 200 study requests from FDA. Contrast 
this with the change that from the prior 6 years, when only 11 studies 
had been done.
  As the Food and Drug Administration itself said in its report to 
Congress, the Better Pharmaceuticals for Children Act has had 
``unprecedented success,'' and ``the pediatric exclusivity provision 
has done more to generate clinical studies and useful prescribing 
information than any other regulatory or legislative process to date.''
  This Act has helped get drugs to kids who need them, let us better 
understand how drugs work in kids, and also know when we should and 
should not be giving kids certain drugs. Or as Linda Suydam, the FDA 
representative who testified in front of the Health subcommittee 
earlier this year pointed out, ``The results speak for themselves.''
  Let me give you an example of how this has worked.
  Take Lodine, which treats Juvenile rheumatoid arthritis. This drug 
did not have safety and effectiveness in children prior to this 
program. With the studies, we have determined a new indication for 
children 6-16 years in age and recommended a higher dosage in younger 
children.
  Contrast this with the traditional mindset of just ``taking the pill 
and breaking it in half'' to determine the dosage for children.
  This has been a fantastic law. And we can do better.
  Six of the 10 most used drugs by children have not been studies 
because they are off-patent. This bill provide the funds for the 
studies to be completed on those off-patent drugs that are used so 
often to treat our children. Furthermore, we have developed a 
foundation to provide resources for the completion of these studies 
that will have so much value.
  Some will argue that this is a Republican bill, helping drug 
companies. Nothing could be further from the truth. This bill, which I 
am proud to work on with Ms. Eshoo, is the very essence of 
bipartisanship. It passed out of the Energy and Commerce Committee by a 
vote of 41-6. And this bill has had more Democrat cosponsors than 
Republican, including several members of the committee.
  Some of my colleagues on the opposite side of the aisle will try to 
suggest that this bill is both costly and helps blockbuster drugs stay-
off competition. This provision is not about blockbuster drugs. Over 
half of the 38 drugs that have been granted exclusivity do not even 
make the list of top 200 selling drugs.
  Simply put, this bill is good policy. It is sound, it is tested. It 
is tried. It works.
  We need to reauthorize pediatric exclusivity. We need to send the 
bill to the President for his signature. America's kid's are counting 
on it.
  I urge my colleagues to vote ``yes'' on S. 1789
  I would like to clarify a point regarding a provision in this 
legislation. It is my understanding regarding section 15 that the 
eleven voting members of the pediatric subcommittee of the Oncologic 
Drugs Advisory Committee, cited in section 15(2)(A) shall be drawn from 
the pediatric oncology specialists listed in (2)(B) of the bill.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 2 minutes.
  Mr. Speaker, I hear the gentleman from Pennsylvania (Mr. Greenwood), 
who does outstanding work on the Subcommittee on Health on a variety of 
issues, say that opponents to this bill offered a Rube Goldberg 
collection of responses or fixes, if you will, to this problem that we 
believe exists, this problem of paying the drug companies in many cases 
tens, sometimes hundreds of millions, of dollars, and in one case over 
$1 billion to do a study that costs simply $4 million.
  Our proposals to fix this are not at all Rube Goldberg. One was to 
reduce the 6-month exclusivity to 3 months so a drug company, by 
investing $4 million, would then only make tens of millions of dollars, 
or $100 million instead of $200 million. That was a very simple, 
straightforward solution.
  Another was simply to reimburse the drug company for the study they 
did. If they paid $4 million for the study, then reimburse them $4 
million; or we were generous enough to say reimburse them $8 million or 
$12 million. We said, give them 100 percent or 200 percent return on 
investment, but do not raise the price, as this legislation does, do 
not raise the price of Prilosec, Prozac, Zocor, and Neurontin $50 to 
$70 per prescription.
  Remember, Mr. Speaker, everyone that votes for this legislation is 
saying to her constituents or his constituents, yes, I am signing off 
on increasing for at least 6 months the price of Prilosec and Prozac 
and Zocor and Neurontin $50 to $70 per prescription. It is not the 2 
percent that the gentleman from Louisiana (Mr. Tauzin) talks about 
industry-wide. That may be true; I do not dispute his numbers. But for 
those four drugs and for some others, the cost of Prilosec will go up 
$50 to $70 for that 6-months for consumers, for our constituents. So 
will the cost of Prozac, Zocor, and Neurontin.
  In times of recession, when people are losing their jobs, when the 
economy seems to be going downward, is that what we want to do is say 
to our constituents it is okay, pay $50 or $60 or $70 per prescription, 
it is for the good of some other cause?
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentlewoman from Maryland (Mrs. Morella).
  Mrs. MORELLA. Mr. Speaker, I thank the chairman of the Committee on 
Commerce for yielding time to me, and for his leadership in bringing 
this bill, which I think is an important one, to the floor.

[[Page 26429]]

  Mr. Speaker, I am in strong support of S. 1789, the Best 
Pharmaceuticals for Children Act; and I want to congratulate the 
sponsor of the bill, the gentleman from Pennsylvania (Mr. Greenwood), 
and the gentlewoman from California (Ms. Eshoo) for working on crafting 
this legislation, which is important. It is a much-needed piece of 
legislation. It creates an incentive for pharmaceutical companies to 
conduct pediatric studies to increase pediatric information.
  Children are subject to many of the same diseases as adults and, by 
necessity, are often treated with the same drugs. According to the 
American Academy of Pediatrics, only a small fraction of all drugs 
marketed in the United States has been studied in pediatric patients; 
and a majority of marketed drugs are not labeled or are insufficiently 
labeled for use in pediatric patients.
  Safety and effectiveness information for the youngest pediatric age 
groups is particularly difficult to find in product labeling. The 
absence of pediatric testing and labeling may also expose pediatric 
patients to ineffective treatment through underdosing, or may deny 
pediatric patients the ability to benefit from therapeutic advances 
because physicians choose to prescribe existing, less-effective 
medications in the face of insufficient pediatric information about a 
new medication.
  In addition, pharmaceutical companies have little incentive to 
perform pediatric studies on drugs marketed primarily for adults; and 
FDA efforts to increase pediatric testing and labeling of certain drugs 
have failed. As a result, the FDA issued a report in January of this 
year, 2001, that the pediatric exclusivity provision was ``highly 
effective in generating pediatric studies on many drugs, and in 
providing useful new information in product labeling.''
  I urge my colleagues to support this bill, as there is no greater job 
that Congress can undertake than to improve and enhance the health of 
children.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, a study from the Department of Health and Human Services 
in a January, 2001, ``Status Report to Congress,'' the Food and Drug 
Administration, within Health and Human Services, wrote that ``the 
impact of the lack of lower-cost generic drugs on some patients, 
especially those without health insurance and the elderly, may be 
significant.''
  This government report from the Food and Drug Administration 
concluded that ``the greatest burden of this increase will fall on 
consumers with no private or public insurance support, which may 
disproportionately affect lower-income purchasers, and the pediatric 
exclusivity provision imposes substantial costs on consumers and on 
taxpayers.''
  Mr. Speaker, I sit here amazed that this Congress today is about to 
pass legislation to increase the cost of drugs, of prescription drugs, 
to America's elderly and to consumers of these prescription drugs, when 
this Congress has done nothing for unemployed workers, has done nothing 
for health insurance for people that are unemployed, has done nothing 
in terms of an economic stimulus package.
  We will not pass a stimulus package, we will not do anything for 
125,000 laid-off airline workers, we will not do anything for the 
millions of newly laid-off workers in this country, we will not do 
anything about 45 million uninsured Americans, one-fourth of whom are 
children. Yet in the name of a children's bill, which is very misnamed, 
in the name of that legislation, of that group, we are going to raise 
prescription drug prices.
  I repeat, Mr. Speaker, that for certain drugs, like Prilosec and 
Prozac and Zocor and Neurontin, a vote for this bill is saying yes to 
the drug companies adding $50 to $70 per cost of prescriptions.
  So people watching this should understand, as we all go home and talk 
to our constituents, we just might get asked, Why did you vote for this 
pediatric exclusivity provision, which adds to the cost of my Prozac, 
Zocor, Neurontin, or Prilosec?
  Mr. Speaker, in the midst of a recession, this makes no sense to add 
to the cost of prescription drugs for America's elderly and for the 
consumers of these drugs.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, this bill is not about the stimulus package, it is not 
about the airlines, it is not about drilling in ANWR. It is about 
children. It is about whether or not we are going to continue a law 
that is working; not pass a new law, but simply continue a law that is 
working, and that everyone who has looked at it says it is working not 
just well, but exceptionally well.
  Let me point out a couple of things:
  One, the bill does not raise drug costs to anybody. It simply extends 
pediatric exclusivity, exclusivity of patents, for 6 months. It does 
not do it because the drug company wants that. It does it because the 
FDA decides that a certain drug that is being given to adults may have 
serious consequences if given to children without a special study done 
on the effects of the drug on the young mind and body of a young child 
to make sure in fact that a drug that is very potent and helpful for 
adults may not have the same effect on children.
  The FDA decides to ask the drug company to do special testing for 
children, and then if they find out that this drug has special effects 
on children, to make sure that the label on the drug indicates that to 
the doctor before he prescribes it to a child.
  Now, I ask Members, does this extra 6 months of patent protection 
help the drug company? Of course it does. They get 6 more months of 
protection under their patent if they agree to do this testing that the 
FDA requests, and if in fact they do it and the tests are run and 
children, we find out, should not be getting a half-dose or quarter-
dose but maybe an eighth of a dose, and under special kinds of 
treatments and circumstances, then we end up protecting children in a 
very special way.
  How much so? We are told that this extra 6 months of exclusivity may 
add about one-half of 1 percent to the drug costs in America during 
that 6 months of extra exclusivity under the patent. What do we get 
back for it? According to the study, we save $7 billion a year in 
health care costs for our children, and so we are not crippling them 
and hurting them with drugs that could hurt and cripple them instead of 
helping them.
  Seven billion dollars, ten-to-one benefits for the most vulnerable, 
the most sacred of all the charges that God has ever presented us with 
on this Earth, the protection of our own children and their health. 
That is what we are talking about.
  It is not about the stimulus plan or drilling in Alaska or airline 
workers. It is about whether or not we are going to continue a law that 
is about to expire; that protects children in this country; that works 
exceptionally well; that was designed by a Democrat, the gentleman from 
California (Mr. Waxman), together with the gentleman from Pennsylvania 
(Mr. Greenwood) in 1997 and has proven itself out.
  So today we cast a vote along with the Senate, which did not cast a 
dissenting vote against this bill. We cast a vote today to continue 
this good law in effect. Is that worth doing? Yes. And I hope this 
House joins me in passing this bill.
  Ms. JACKSON-LEE of Texas. Mr. Speaker, I stand in support of the Best 
Pharmaceuticals for Children Act (S. 1789). Until 1997, American 
children were at substantial risk due to the lack of instructions in 
most prescription drug labels on how to use those drugs in children. 
Since the pediatric exclusivity incentive was enacted in 1997, there 
have been numerous studies of drugs in children, and drug labels are 
finally starting to carry this critical pediatric dosing information. 
It would be shameful for Congress to shut down the investment in 
pediatric studies by failing to reauthorize the pediatric exclusivity 
incentive. The Congress should pass the Best Pharmaceuticals for 
Children Act so that all drugs, present and future, contain the dosing 
information so critical to proper pediatric care.
  The only flaw in the bill is Section 11, which would actually permit 
the FDA to approve drugs that omit critical pediatric dosing 
information. Such omissions could cripple the very

[[Page 26430]]

purpose--complete, accurate pediatric labeling--of the Best 
Pharmaceuticals for Children Act. Consequently, FDA cannot implement 
Section 11 without engaging in notice-and-comment rulemaking under the 
Administrative Procedure Act. This will ensure that if FDA does assert 
the discretion it is granted under Section 11, it will not do so in a 
way that would allow approval of any drug without complete, accurate 
and up-to-date pediatric labeling.

Memorandum to the Untied States Congress Re: Proposed Amendment to the 
                      Hatch-Waxman Act (H.R. 2887)

       Section 11 of H.R. 2887 has the effect of amending the 
     Hatch-Waxman Act to abolish retroactively an existing 
     exclusive marketing period for Glucophage, a pioneer drug 
     manufactured and marketed by Bristol-Myers Squibb (``BMS'') 
     for treatment of Type 2 diabetes. An exclusive marketing 
     period, whether derived from a government grant of a patent 
     or other similar governmental action, is a valuable property. 
     Any legislative effort to terminate such an existing right 
     without compensation raises obvious constitutional problems.
       In the case of Glucophage, the proposed legislative action 
     is particularly egregious since the marketing exclusivity 
     came as a result of extensive studies welcomed by the 
     government and successfully performed by BMS with respect to 
     pediatric use of Glucophage. The FDA authorized and agreed to 
     the studies pursuant to legislation and regulations designed 
     to encourage pediatric testing to maximize health benefits to 
     children. BMS agreed to do the extensive--and expensive--
     testing of this pioneer drug. The results were positive, and 
     accordingly, BMS in the spring of 2000 submitted a 
     supplemental new drug application (``sNDA'') to add pediatric 
     use information to its Glucophage label.
       The FDA approved such labeling and granted BMS three years 
     of pediatric labeling exclusivity as provided under the law. 
     Under existing law and regulations, the grant of labeling 
     exclusivity amounted to a grant of marketing exclusivity for 
     Glucophage for all users, not simply children, because all 
     prescription drugs (including generics) were required by FDA 
     regulations promulgated in 1994 to include pediatric 
     information in their labels. That this broader exclusivity 
     would result from the pediatric labeling was relied upon by 
     BMS when it undertook to conduct the testing. It is this 
     broader exclusivity that Section II of the proposed 
     legislation seeks to eliminate retroactively.
       There is, of course, no question of Congress' 
     constitutional power to change legislative standards for the 
     exercise of regulations prospectively; to do so may raise 
     questions of legislative policy but no legal or 
     constitutional questions. The constitutional problem arises 
     only when the power is exercised to make such changes 
     retroactively--to take away an existing valuable right 
     already vested with respect to an existing product. The 
     Congressional power is broad; the constitutional limitation 
     on that power, narrow. In legislative encouragement of the 
     arts and sciences, Congress is free to expand or contract the 
     period of marketing exclusivity with respect to future 
     creations and inventions. But it is not free to take away 
     grants of existing exclusivity without compensation.
       The fact that the marketing exclusivity is achieved 
     indirectly through labeling exclusivity rather than through a 
     direct marketing grant is of no moment from either a policy 
     or a constitutional perspective. There is no question that 
     the FDA had the authority to do what it did both in granting 
     labeling exclusivity and in regulating the requirements with 
     respect to labeling. That since 1994 labeling exclusivity 
     amounted to marketing exclusivity was well known and served 
     as a means to promote research and testing for pediatric use 
     as well as promoting safety and efficiency.
       Section 355a (Pediatric studies of drugs) was enacted in 
     1997, three years after the FDA regulation requiring 
     pediatric use information be included in all labeling. It 
     provides for a six month extension of marketing exclusivity 
     for a drug where its manufacturer agrees to a request by the 
     FDA for pediatric research and testing and performs the 
     required tests in a timely fashion. This extension is granted 
     whether or not the drug is approved for pediatric use. But if 
     an application for pediatric use is made and a sNDA granted, 
     the use becomes subject to the FDA's labeling requirements.
       Without some period of exclusivity there would be little or 
     not incentive to apply for the sNDA. If labeling exclusivity 
     did not include marketing exclusivity it would have little 
     value. Generic manufacturers producing bio-equivalent drug 
     could not include pediatric use on the labels, but the 
     medical profession (especially HMO's) would be aware of the 
     use and would prescribe the generic rather than the labeled 
     drug.
       As a policy matter one can agree or disagree with the FDA's 
     1994 regulation that pediatric information must, for reasons 
     of safety and effective use, be included in every 
     prescription drug. The proposed legislation disagrees with 
     any such requirement. Whatever the impact of this change on 
     future pediatric research and testing, Congress is obviously 
     free to make such a policy choice. But with respect to 
     products already marketed under an exclusive pediatric label, 
     the effect of such a change is to destroy a valuable property 
     right. The government should not engage in such an act, and 
     the constitution requires that such a taking be compensated.
       The attached memo discusses the constitutional question. As 
     a policy matter, there is little to be gained by engaging in 
     almost certain litigation where there is no important 
     principle to be established. Glucophage may be the only drug 
     involved (or at least one of a small number), and it is easy 
     to make the legislation prospective only. Even in the 
     unlikely event that the government would prevail, that 
     victory would almost certainly be hedged with a variety of 
     technical requirements which would create future legislative 
     problems. A loss could be costly in monetary terms. And 
     either a victory or a loss almost certainly would involve 
     language problematic in terms of governmental fairness.
                                  ____


 Constitutionality of Proposed Amendment to the Hatch-Waxman Act (H.R. 
                                 2887)

       This memorandum respectfully addresses the constitutional 
     infirmity of H.R. 2887 sec. 11.
       The underlying statute regarding new drug approvals, the 
     Hatch-Waxman Act, provides an initial period of marketing 
     exclusivity for a pioneer drug manufacturer that holds an 
     approved new drug application (``NDA''). See 21 U.S.C. 
     Sec. 355(j)(5)(D)(ii). It also provides an additional period 
     of labeling exclusivity for a pioneer that holds an approved 
     supplemental new drug application (``sNDA'') based on a new 
     use indication developed after the basic drug had been 
     approved. See id, at Sec. 355(j)(5)(D)(iv).
       Once the initial exclusivity expires, a generic drug maker 
     is entitled to seek approval for an abbreviated new drug 
     application (``ANDA'') based on a demonstration of bio-
     equivalence with the pioneer drug. See id at 
     Sec. 355(j)(2)(A)(iv). The FDA may not approve an ANDA unless 
     the labeling is the ``same as the labeling approved for the 
     listed drug''. See 21 U.S.C. Sec. 355(j)(2)(A)(v). although 
     pursuant to 1992 FDA regulations, a generic drug label may 
     differ from the label of the pioneer drug by ``omission of an 
     indication or other aspect of labeling protected by patent or 
     accorded exclusivity under [Hatch-Waxman]'' (see 21 C.F.R. 
     Sec. 314.94(a)(8)(iv)), omissions may be approved only if 
     they ``do not render the proposed drug product less safe or 
     effective than the listed drug for all remaining, 
     nonprotected conditions of use''. 21 C.F.R. 
     Sec. 314.127(a)(7)(emphasis added).
       In 1994, the FDA created an exception to the above 
     regulation, concerning acceptable label omissions, affording 
     pioneer drug manufacturers extended total marketing 
     exclusivity based on the development of new pediatric use 
     indications. In particular, the FDA adopted regulations 
     requiring that pediatric information be included in the 
     labeling of every prescription drug. See 21 C.F.R. 
     Sec. 201.57(f)(9)(ii). The FDA based the new regulations on 
     its finding that ``[t]his action promotes safer and more 
     effective use of prescription drugs in the pediatric 
     population''. 59 Fed. Reg. 64,240 (Dec. 13, 1994). With this 
     regulation, the FDA noted that ``a drug product that is not 
     in compliance with revised Sec. 201.57(f)(9) would be 
     considered to be misbranded and an unapproved new drug under 
     the act''. 57 Fed. Reg 47,423, 47,425 (Oct. 16, 1992).
       Further, in 1997, Congress enacted legislation providing 
     pioneer drug manufactures a six-month period of marketing 
     exclusivity in return for performing pediatric studies on 
     already approved drugs, even if the studies do not yield 
     results permitting pediatric labeling. See 21 U.S.C. 
     Sec. 355a.
       These statutes and regulations collectively were designed 
     to encourage drug manufacturers to invest in pediatric 
     testing in an effort to maximize the health benefits to 
     children. A review of the record plainly reveals this intent 
     as well as the benefits achieved. For example:
       The FDA described its 1992 proposed pediatric labeling 
     regulation as an initiative to ``stimulate development of 
     sufficient information for labeling to allow the safe and 
     effective use of drugs in children''. 57 Fed. Reg. 47,423, 
     47,424 (Oct. 16, 1992).
       In its 1994 Unified Agenda, the FDA explained that its then 
     forthcoming final regulation was created in response to a 
     concern that prescription labeling did not contain adequate 
     information about pediatric drug use. 59 Fed. Reg. 57,572 
     57,577 (Nov. 14, 1994).
       In its mandated 2001 status report to Congress, the FDA 
     reported that pediatric exclusivity has ``done more to 
     generate clinical studies and useful prescribing information 
     for the pediatric population that any other regulatory or 
     legislative process to date'' S. Rep. No. 107-79 (2001).
       Linda Suydam, Senior Associate FDA Commissioner, testified 
     at a House hearing that the ``purpose of encouraging 
     pediatric studies is to provide needed pediatric efficacy, 
     safety and dosing information to physicians in product 
     labeling''. Food and Drug Administration Modernization: 
     Hearing Before the House Comm. on Energy and Commerce, 107th 
     Cong. (May 3, 2001) (statement of Linda A. Suydam).

[[Page 26431]]

       At a May 2001 Senate hearing, Senator Chris Dodd wanted 
     that the absence of pediatric labeling poses significant 
     risks to children describing it as ``playing Russian roulette 
     with their health''. Pediatric Drug Testing: Hearing Before 
     the Senate Comm. on Health, Educ., Labor and Pensions, 107th 
     Cong. (May 8, 2001) (statement of Senator Dodd).
       In the context, the FDA, in 1998 and 1999, issued ``Written 
     Requests'' to Briston-Myers Squibb (``BMS'') for the 
     performance of extensive pediatric studes on Glucophage, a 
     pioneer drug initially approved in 1995 for the treatment of 
     type 2 diabetes. At that time, no oral type 2 diabetes 
     treatment had been approved for pediatric use. BMS completed 
     the studies as agreed. IN the spring of 2000, BMS submitted 
     an sNDA seeking approval to add pediatric use informaiton to 
     the Glucophage label based on the findings of its studies. As 
     expected, the FDA approved the sNDA, authorized BMS to add 
     pediatric use informaiton to the Glucophage label, and 
     granted three years of Hatch-Waxman labeling exclusivity 
     pursuant to 21 U.S.C. Sec. 355(j)(5)(D)(iv). Under existing 
     law, that grant resulted in total marketing exclusivity with 
     respect to Glucophage for the applicable period because BMS 
     has acquired exclusive rights to the only pediatric use 
     indication that applied under the pediatric labeling 
     requirements. See 21 C.F.R. Sec. 201.57(f)(9)(iv).
       H.R. 2887 sec. 11, which is apparently widely referred to 
     as the ``Anti-Glucophage Bill'', proposes to revise the 
     Hatch-Waxman Act to override the current requirement that 
     generic versions of pioneer drugs bear labeling for pediatric 
     indications. Accordingly, the proposed legislation would 
     eliminate the marketing exclusivity that BMS currently enjoys 
     as a result of its exclusive right to the pediatric use 
     labeling for Glucophage.
       The retroactive impact of such a government action offends 
     notions of basic fairness and has long been frowned upon by 
     our courts. ``[R]etro-spective laws are, indeed, generally 
     unjust; and as has been forcibly said, neither accord with 
     sound legislation nor with the fundamental principles of the 
     social compact''. Eastern Enters v. Apfel, 524 U.S. 498, 533 
     (1998) (quoting 2 J. Story, Commentaries on the Constitution 
     Sec. 1398 (5th ed. 1891)). If H.R. 2887 is signed into law, 
     it would effect an unconstitutional taking. See U.S. Const. 
     amend. V (``private property [shall not] be taken for public 
     use without just compensation'').
       BMS, pursuant to Written Requests from the FDA, went to 
     great lengths to perform pediatric studies on Glucophage. The 
     fruits of BMS's research and development effort--including 
     data relating to, among other things, the drug's indication 
     and use, clinical pharmacology, adverse reactions, and dosage 
     and administration--constitute intellectual property and 
     qualify as trade secrets under state law. See Restatement 
     (First) of Torts Sec. 757 cmt. b (1939) (trade secret may 
     consist of ``any formula, pattern, device or compilation of 
     information which is used in one's business, and which gives 
     him an opportunity to obtain an advantage over competitors 
     who do not know or use it.'') (cited with approval in Ashland 
     Mgmt. Inc. v. Janien, 624 N.E.2d 1007, 1012-13 (N.Y. 1993)). 
     Such intangible property is subject to the protections of the 
     Takings Clause of the Constitution. See e.g., Ruckelshaus v. 
     Monsanto Co., 467 U.S. 986, 1003-04 (1984) (trade secrets in 
     pesticide testing data); Patlex Corp. v. Mossinghoff, 758 
     F.2d 594, 599-600 (Fed. Cir. 1985), modified on reh'g on 
     other grounds, 771 F.2d 480 (Fed. Cir. 1985) (laster 
     technology patents); Tri-Bio Labs., Inc. v. United States, 
     836 F.2d 135, 142 (3d Cir. 1987) (trade secrets in animal 
     drug testing data).
       Moreover, similar to a patent, the marketing exclusivity 
     that BMS was granted in exchange for the dedication of its 
     intellectual property constitutes a valid property interest. 
     See Patlex Corp., 758 F.2d at 599 (``The encouragement of 
     investment-based risk is the fundamental purpose of the 
     patent grant, and is based directly on the right to 
     exclude.''). Our legal system makes plain that the right to 
     exclude is ``essential'' to the concept of private property. 
     See Kaiser Aetna v. United States, 444 U.S. 164, 176 (1979).
       In determining whether a taking of property has occurred, 
     courts will consider the following factors: (1) the 
     government action's interference with reasonable investment 
     backed expectations; (2) the character of the action; and (3) 
     the economic impact of the action. See Ruckelshaus, 467 U.S. 
     at 1005.
       With respect to Glucophage, there can be little question 
     that H.R. 2887 sec. 11 would turn BMS's reasonable 
     investment-backed expectation on its head. The Supreme 
     Court's opinion in Ruckelshaus is instructive. Monsanto, a 
     pioneer manufacturer of pesticides, successfully challenged 
     legislation that would have permitted the Environmental 
     Protection Agency to disclose and/or use trade secret data 
     from Monsanto's pesticide approval applications filed after a 
     1972 amendment guaranteeing that no such use or disclosure 
     would occur and prior to a 1978 amendment repealing that 
     protection. The Court found the interference with reasonable 
     investment backed expectations ``so overwhelming . . . that 
     it dispose[d] of the taking question''. Ruckelshaus, 467 U.S. 
     at 1005 (emphasis added).
       Similarly, BMS has developed intellectual property 
     necessary to support its Glucophage sNDA for pediatric use. 
     BMS submitted that intellectual property to the FDA in 
     exchange for what BMS understood to be a promise of marketing 
     exclusivity. Although the proposed legislation here nominally 
     would preserve BMS's use of pediatric data by making that 
     portion of the label exclusive, the taking would be effected 
     through off-label sales, i.e., the lack of any given 
     indication in a generic's label will not prevent a generic 
     drug from being prescribed or substituted for the branded 
     drug for that indication. In 1994, well before the Written 
     Requests issued for pediatric testing of Glucophage, the FDA 
     adopted regulations precluding such off-label sales from 
     undermining the exclusivity granted with regard to pediatric 
     use indications. BMS invested accordingly. Now that Congress 
     has secured the desired benefits from BMS, it is refusing to 
     follow through on its promise. Such action plainly interferes 
     with reasonable investment-backed expectations.
       Although the character of the government action here is not 
     the same as that of the traditional physical invasion of 
     property, the effect is the same. The proposed legislation 
     would nullify, not just diminish the value of BMS's property 
     interest. See Ruckelshaus, 467 U.S. at 1012 (change in 
     regulation ``destroy[ed]'' value of trade secrets). The 
     ``Anti-Glucophage Bill'', as designed, completely would 
     deprive BMS of its intellectual property and its 
     corresponding entitlement to market the drug on an exclusive 
     basis for the remainder of the applicable period.
       With respect to the economic impact of the proposed 
     legislation, there is little question that it would be 
     severe. See Eastern Enters., 524 U.S. at 534 (plurality) 
     (finding a taking based on retroactive liability that was 
     ``substantial and particularly far reaching''); United States 
     Fid. & Guar. Co. v. McKeithen, 226 F.3d 412, 416 (5th Cir. 
     2000) (finding a taking based on ``considerable, novel 
     financial burden''). Indeed, the action would deprive BMS of 
     Glucophage's market value to the extent of billions of 
     dollars. If the proposed legislation were enacted, and 
     assuming the courts did not block its implementation, the 
     appropriate measure of BMS's injury would be extremely high. 
     See United States v. W.G. Reynolds, 397 U.S. 14, 16 (1970) 
     (``just compensation' means the full monetary equivalent of 
     the property taken . . . the owner is entitled to the fair 
     market value of the property''). BMS would have to be put in 
     ``as good position pecuniarily as [it] would have occupied if 
     [its] property had not been taken''. See United States v. 
     Miller, 317 U.S. 369, 373 (1943).
       For these reasons, the enactment of H.R. 2887 sec. 11 would 
     constitute an unconstitutional taking of BMS's property for 
     which it would be entitled to just compensation. I 
     respectfully urge Congress to reconsider the constitutional 
     implications of this provision of the proposed legislation.

  Ms. ESHOO. Mr. Speaker, I rise in support of the Best Pharmaceuticals 
for Children Act, which I'm proud to sponsor with Mr. Greenwood of 
Pennsylvania.
  This bill is the conferenced version of legislation that passed the 
House a month ago on the suspension calendar 338-86.
  Importantly the bill we will vote on today and send to the President 
closes the ``Glucophage loophole'' which allowed one company to get an 
additional 3 years of marketing exclusivity. This bill ensures that no 
company will be able to take advantage of the exclusivity granted by 
this very important legislation.
  This legislation extends the pediatric exclusivity provision, one of 
the most successful programs created by Congress to inspire medical 
therapeutic advances for children.
  Prior to its enactment, 80 percent of all medications had never been 
tested for use by children, even though most are widely used by 
pediatricians to treat them.
  Many of these drugs carried disclaimers stating that they were not 
approved for children. Pediatricians cut pills in half or even in 
fourths for children.
  Throughout this period, we were basically experimenting on children, 
forcing doctors to rely on anecdotal information or guesswork. This was 
not acceptable for our nation's children.
  In 1997 the Congress passed the pediatric exclusivity provision as 
part of the FDA Modernization Act, which Congressman Barton and I 
sponsored.
  This provision has made a dramatic change in the way pediatricians 
are practicing and administering medicine to children. Now, 
pediatricians have the necessary dosage guidance on drug labels to 
administer drugs safely to children.
  But there are many more drugs that can and should be used in the 
pediatric population. This bill ensures that those drugs will also be 
studied and information on safe use will be provided to pediatricians.
  Because previous attempts to address drug studies for children had 
failed, this provision was given a four-year lifespan. It expires 
January 1, 2002, which is why we're here today.

[[Page 26432]]

  The pediatric exclusivity provision provides pharmaceutical companies 
with an incentive to study drugs for children . . . six months of 
additional market exclusivity.
  This incentive has made a dramatic difference.
  Since the law has been in place, the FDA has received close to 250 
proposed pediatric study requests from pharmaceutical companies and has 
issued nearly 200 requests to conduct over 400 pediatric studies.
  By comparison, in the seven years prior to enactment of this 
provision, only 11 studies were completed.
  The FDA has granted market exclusivity extensions for 33 products. 20 
products include new labeling information for pediatricians and 
parents.
  What this means is that doctors are now making better-informed 
decisions when administering medicine to children.
  During our Committee deliberations a number of proposals by my 
colleagues Representatives Pallone and DeGette were adopted and are 
part of the underlying bill we will vote on today.
  The bill before us also makes some significant improvements to the 
original pediatric exclusivity provisions by creating an off-patent 
drug fund within NIH and setting up a public-private foundation to 
support the research necessary for these important drugs.
  The bill also addresses some concerns that were raised by both the 
FDA and GAO with regard to labeling. Our bill enhances the labeling 
process and provides the FDA Commissioner the authority to misbrand a 
drug if companies drag their heels.
  28 National Children's health advocacy groups support this bill's 
passage . . . among them are the American Academy of Pediatrics, the 
March of Dimes, and the National Association of Children's Hospitals. 
They're requesting that Congress not delay in passing this legislation.
  Our colleagues in the Senate have acted . . . last week, the Senate 
unanimously passed the same bill sponsored by Senators Dodd and DeWine.
  As I said during the initial House consideration of this bill, many 
of my colleagues have concerns, valid concerns with the cost of drugs.
  I continue to share these concerns, and I shall continue to work for 
a legislative solution to provide prescription drug coverage for our 
seniors.
  This bill should not have to bear the burden of what Congress has 
failed to address. The FDA, the GAO, and one of the largest groups of 
children's health advocacy groups say this is the best way to provide 
safe and effective drugs for children.
  The benefits of this program are clear and bear repeating--in the 
seven years prior to enactment of this provision only 11 studies on 
drugs for children were completed; since its enactment four years ago 
the FDA has received close to 250 proposed pediatric studies.
  Since September 11th the entire Congress has legitimately been 
addressing national security concerns. Today, we can ensure the health 
security of our children by passing this bill overwhelming and sending 
it to the President for his signature.
  Mr. TOWNS. Mr. Speaker, I am very pleased that the Congress will act 
today to preserve the gains that we have made in the development of 
pediatric drugs. I want to congratulate my colleagues, the gentleman 
from Pennsylvania, Mr. Greenwood, and the gentlelady from California, 
Ms. Eshoo, on their hard work in promoting the reauthorization of 
pediatric exclusivity. Before the passage of ``The Better 
Pharmaceuticals for Children's Act in 1997'', many children were denied 
access to medicines because drugs were not produced in dosable forms 
that could be used by pediatric patients. It was not very encouraging 
to be a pediatrician prescribing medicine to children. It was mostly 
guesswork.
  This legislation provided an incentive for research-based 
pharmaceutical companies to conduct studies on pediatric indications 
for medicines. The Act included additional market exclusivity for 
pediatric studies on new and existing pharmaceuticals. The January 2001 
Status Report to Congress from the Food and Drug Administration stated 
that, ``the pediatric exclusivity provision has done more to generate 
clinical studies and useful prescribing information for the pediatric 
population than any other regulatory or legislative process to date.''
  We should not return to pediatric medicine as it was practiced before 
1997. By renewing this law, which will now include a fund to conduct 
studies on off-patent drugs and reduce the time by which the labeling 
information reaches consumers, we will ensure that we can continue 
innovations in the practice of pediatrics and the development of new 
drug therapies for our children. I know our doctors and their young 
patients and their parents are pleased that we are moving forward 
rather than backward in terms of pediatric medications. The March of 
Dimes, The National Association of Children's Hospitals and the 
American Academy of Pediatrics all support this legislation and I would 
urge my colleagues to join them by voting for S. 1789.
  Mr. BURTON of Indiana. Mr. Speaker, today we are voting on the 
passage of the Best Pharmaceuticals for Children Act. Everyone in 
Congress wants to see better and safer pharmaceuticals for children.
  As Chairman of the Committee on Government Reform, I have made 
oversight of health care issues a priority. In particular, I have been 
greatly concerned with the safety and efficacy of children's vaccines 
and drugs given to children with cancer. I am greatly concerned that we 
continue to inject babies and young children with vaccines that contain 
mercury--a known neurotoxin. I hope that through the passage of this 
bill that the Food and Drug Administration (FDA) takes seriously the 
concerns of the public and Congress that all products given to children 
need to be adequately and appropriately tested in children to take the 
guess work out of safety and efficacy issues as well as dosing.
  I hope that the Department will make a priority of reviewing products 
that contain hazardous ingredients such as mercury. All products, 
including vaccines need to be safe and effective. Ingredients that have 
been banned in other forms of medication the way that thimerosal has, 
should certainly be high on the list for review and consideration of 
removal from the marketplace. Thimerosal, which has been used since the 
1930's, is not routinely tested for safety and efficacy in new 
products. It was grandfathered in and the FDA and manufacturers presume 
it to be safe. We know a lot more about the neurotoxic affects of 
mercury today than we did in 1930. This mercury derivative may be a 
contributing factor in the dramatic rise in rates of autism, pervasive 
developmental disorders, and speech and language delays. While the FDA 
continues to state there is no proof of harm, they are making that 
presumption in the absence of scientific evidence. I continue to feel 
that these products pose an unacceptable risk to our nation's children 
and should be recalled. Every time the Institute of Medicine conducts a 
review of vaccine research, they have recommended research to look at 
the long-term effects of vaccines. To date the research funding in this 
area has been woefully inadequate. There is a paucity of data in the 
safety of children's vaccines. I hope that the Director of the National 
Institutes of Health will review the numerous research recommendations 
offered in several Institute of Medicine reports published in the last 
ten years and quickly move to develop a Request Agenda, including 
funding, and a Request for Proposal to be issued and funded next year. 
I will remain vigilant on this issue.
  I am also concerned that many of the drugs used in pediatric oncology 
are being used ``off-label''. While I support the option of using a 
drug off-label, I have been concerned that chemotherapy agents that are 
routinely given to children have not been evaluated by the Food and 
Drug Administration and found to be safe and effective for children and 
their specific type of cancer. We need to do a better job in pediatric 
cancers. We need safer, less toxic cancer treatments that do cure 
cancer and do not adversely affect a child's IQ, their hearing, speech, 
sight, their gait, and that do not generate secondary cancers.
  In this Bill there are provisions, which call for referral to the 
Advisory Committees disputes on labeling changes. As part of a 
Committee on Government Reform oversight investigation, we learned that 
many individuals who sit on FDA advisory committees have been granted 
waivers for their conflict of interests--financial ties to the 
companies or organizations affected by Committee on which they are 
serving. Stock ownership in affected or competing companies, research 
grants from affected or competing companies, or research grants or 
personal/financial interests in affected and competing products needs 
to be very carefully scrutinized. The FDA needs to be more cautious in 
the granting of waivers to financial conflicts of interest to its 
advisory committee members, especially those reviewing products that 
affect children. We must not have even the appearance of a conflict of 
interest in the review of safety and efficacy of products that will be 
given to our nation's children.
  I remain committed to improving our health care system. We as a 
government need to embrace the role of nutrition, lifestyle and 
behavior, traditional healing systems from other cultures, 
complementary and alternative medicine and work to gather the existing 
science in these and conventional medicines. We need to identify areas 
were there is a gap in the scientific evidence, and work aggressively 
to fill

[[Page 26433]]

this research gap. We also need to provide accurate and balanced 
information to the public and allow Americans to make their own medical 
decisions. Additionally, we need to work to extend assess to therapies 
that are both safe and effective in government-funded programs where 
feasible.
  Mr. FORBES. Mr. Speaker, I rise in support of the Best 
Pharmaceuticals for Children Act, to ensure that our children get the 
medicines that are best suited to their growing bodies.
  Four years ago, Congress authorized incentives for pharmaceutical 
manufacturers to do pediatric research for their products and to 
provide pediatric labeling information. That legislation has been an 
extraordinary success for our children. In the six years prior to 
enactment of that change in law, only 11 pediatric studies were 
conducted by the pharmaceutical industry. But, in the four years since 
its enactment, the industry has agreed to more than 400 such studies.
  Mr. Speaker, children are not simply small adults. They have special 
needs for nutrition and medical care, and the pharmaceutical products 
we develop should reflect these needs. The pediatric exclusivity 
provision Congress passed in 1997 ensures that they do. Today's 
legislation simply reauthorizes that expiring provision through Fiscal 
Year 2007.
  I appreciate the bipartisan effort of the Energy and Commerce 
Committee to move this bill so swiftly through the legislative process, 
and I encourage my colleagues to support it.
  Mr. DINGELL. Mr. Speaker, I rise to oppose passage of S. 1789, a bill 
that would continue a program that grants drug companies an additional 
six month period of market exclusivity, if they conduct tests on the 
use of their drugs for children. This bill is a slight improvement on 
H.R. 2887 that passed this House last month. We all agree that improved 
testing and labeling of prescription drugs for use in children is a 
good thing. The only question for debate is how to accomplish that 
important public health objective.
  The bill does close a potential loophole by instructing the FDA to 
approve generic drugs without proprietary pediatric labeling awarded to 
product sponsors under the Hatch-Waxman Act. But I continue to oppose 
the bill because its central feature, exclusivity, is about further 
increasing the profits of an already bloated industry--an industry that 
does not seem to be able to moderate its pricing practices even as it 
increasingly burdens its customers, American consumers, and taxpayers.
  The impact of pediatric exclusivity falls directly on those who 
consume the drugs that get the exclusivity. Who are these people? They 
include seniors, many that cannot afford the prescription drugs they 
need. And, ironically, pediatric exclusivity can hurt the very people 
it is intended to help because many unemployed, uninsured, and working 
poor cannot afford the expensive drugs needed by their children.
  What benefit have consumers and taxpayers received for this multi-
billion dollar extension of monopoly prices? Of the 38 drugs that have 
been granted pediatric exclusivity, less than 20 of them now have 
pediatric labeling. The Committee and the Senate rejected, unwisely in 
my view, an amendment by Representative Stupak that would have closed 
this dangerous loophole in the law by conditioning the grant of 
exclusivity to actual pediatric labeling.
  This bill forces our citizens to overpay drug companies for pediatric 
testing that should simply be required by law. I oppose it.
  Mr. BILIRAKIS. Mr. Speaker I rise today in support of S. 1789, The 
Best Pharmaceuticals for Children Act. If it's not broken--don't fix 
it. By all accounts Mr. Speaker, this program is a resounding success. 
According to the Food and Drug Administration, ``the pediatric 
exclusivity provision has been highly effective in generating pediatric 
studies on many drugs and in providing useful new information in 
product labeling.'' The American Academy of Pediatrics states that they 
``can not overstate how important this legislation has been in 
advancing children's therapeutics.''
  The legislation before us today is virtually identical to H.R. 2887, 
which passed the House on November 15, 2001 by a 338-86 vote. Moreover, 
this legislation has recently passed the Senate unanimously.
  The legislation reauthorizes the pediatric exclusivity program for an 
additional six years. It keeps the present incentive in place, and 
makes important improvements. The legislation ensures that off-patent 
generic drugs are studied, and tightens the timeline for making 
labeling changes.
  The bill retains the improvements that were in both the Senate and 
House versions to ensure timely labeling changes occur. First, we make 
pediatric supplements ``priority supplements,'' which will dramatically 
speed up the process for getting new labels. Second, by giving the 
Secretary authority to deem drugs misbranded we guarantee that label 
changes will be made. We believe, and children's groups agree, that the 
changes we make are the right compromises to maintain the incentives 
and get labels changed.
  I would also like to acknowledge the hard work of my colleagues 
Representatives Jim Greenwood and Anna Eshoo. These two Members have 
worked tirelessly to bring this process to a conclusion, and it has 
been a pleasure working with them. I again would also like to thank the 
staff that worked so long and hard on this legislation, including John 
Ford, David Nelson, Eric Olson, Brent Del Monte, Alan Eisenberg, and 
Steve Tilton. And, yet again a special thanks to Pete Goodloe our 
legislative counsel. We are so thankful for all of this help.
  Mr. Speaker, this is great legislation that the Subcommittee and Full 
Committee put a lot of thought and effort into. It does wonders for 
children's health and is widely supported. I urge all Members to 
support its swift passage.
  Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time, 
and I yield back the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Simpson). The question is on the motion 
offered by the gentleman from Louisiana (Mr. Tauzin) that the House 
suspend the rules and pass the Senate bill, S. 1789.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the Senate bill was passed.
  A motion to reconsider was laid on the table.

                          ____________________