[Congressional Record Volume 147, Number 141 (Thursday, October 18, 2001)]
[Senate]
[Pages S10816-S10819]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 BEST PHARMACEUTICALS FOR CHILDREN ACT

  Mr. DODD. Madam President, I ask unanimous consent that the Senate 
now proceed to the consideration of Calendar No. 184, S. 838; that the 
only amendment in order other than the committee-reported substitute be 
a Dodd-DeWine amendment; that the amendment be agreed to, the committee 
substitute, as amended, be agreed to, the bill, as amended, be read 
three times, passed, and the motion to reconsider be laid upon the 
table, with the above occurring with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senate proceeded to consider the bill (S. 838) to amend the 
Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy 
of pharmaceuticals for children, which had been reported from the 
Committee on Health, Education, Labor, and Pensions, with an amendment 
to strike all after the enacting clause and inserting in lieu thereof 
the following:

     SECTION 1. SHORT TITLE.

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

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

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

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

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

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

       ``(a) List of Drugs Lacking Exclusivity for Which Pediatric 
     Studies Are Needed.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary, acting through the 
     Director of the National Institutes of Health and in 
     consultation with the Commissioner of Food and Drugs and 
     experts in pediatric research, shall develop, prioritize, and 
     publish an annual list of approved drugs for which--
       ``(A)(i) there is an approved application under section 
     505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(j));
       ``(ii) there is a submitted application that could be 
     approved under the criteria of section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)); or
       ``(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.); and
       ``(B) 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 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.--
       ``(A) In general.--The Commissioner of Food and Drugs, in 
     consultation with the Director of 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) to all holders of an approved application for 
     the drug under section 505 of the Federal Food, Drug, and 
     Cosmetic Act. Such a request shall be made in accordance with 
     section 505A of the Federal Food, Drug, and Cosmetic Act.
       ``(B) Publication of request.--If the Commissioner of Food 
     and Drugs does not receive a response to a written request 
     issued under subparagraph (A) within 30 days of the date on 
     which a request was issued, the Secretary, acting through the 
     Director of 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.
       ``(C) Disqualification.--A holder that receives a first 
     right of refusal shall not be entitled to respond to a 
     request for contract proposals under subparagraph (B).
       ``(D) 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 
     subparagraph (A).
       ``(2) 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.
       ``(3) Reporting of studies.--
       ``(A) Upon 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 
     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, 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 (4).
       ``(4) Request for labeling changes.--During the 180-day 
     period after the date on which a report is submitted under 
     paragraph (3)(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; and
       ``(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.
       ``(5) Dispute resolution.--If, not later than the end of 
     the 180-day period specified in paragraph (4), 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--
       ``(A) the Commissioner of Food and Drugs shall immediately 
     refer the request to the Pediatric Advisory Subcommittee of 
     the Anti-Infective Drugs Advisory Committee; and
       ``(B) not later than 90 days after receiving the referral, 
     the Subcommittee 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

[[Page S10817]]

       ``(ii) make a recommendation to the Commissioner of Food 
     and Drugs as to appropriate labeling changes, if any.
       ``(6) FDA determination.--Not later than 30 days after 
     receiving a recommendation from the Subcommittee under 
     paragraph (5)(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.
       ``(7) 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 (6), 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.
       ``(8) 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. 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.--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--
       ``(A) 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 by that 
     date, the Commissioner shall immediately refer the matter to 
     the Pediatric Advisory Subcommittee of the Anti-Infective 
     Drugs Advisory Committee;
       ``(B) not later than 90 days after receiving the referral, 
     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) 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; and
       ``(D) 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.''.

     SEC. 5. OFFICE OF PEDIATRIC THERAPEUTICS.

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

     SEC. 6. 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. 7. 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 approvable 
     application for the drug is submitted under section 
     505(b)(1); and
       ``(3) all requirements of this section are met.''.

     SEC. 8. DISSEMINATION OF PEDIATRIC INFORMATION.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C 355a) (as amended by section 4(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 in any way section 552 of title 5 or section 
     1905 of title 18, United States Code.''.

     SEC. 9. CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY 
                   UNDER SECTION 505A OF THE FEDERAL FOOD, DRUG, 
                   AND COSMETIC ACT AND MARKET 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 8) is amended by 
     adding at the end the following:
       ``(n) Clarification of Interaction of Market Exclusivity 
     Under This Section and Market Exclusivity Awarded to an 
     Applicant for Approval of a Drug Under Section 505(j).--
       ``(1) In general.--If a 180-day period under section 
     505(j)(5)(B)(iv) overlaps with a 6-month extension under this 
     section, so that the applicant for approval of a drug under 
     section 505(j) entitled to the 180-day period under that 
     section loses a portion of the 180-day period to which the 
     applicant is entitled for the drug, the 180-day period shall 
     be extended--
       ``(A) if the 180-day period would, but for this subsection, 
     expire after the 6-month extension, by the number of days of 
     the overlap; or
       ``(B) if the 180-day period would, but for this subsection, 
     expire during the 6-month extension, by 6 months.
       ``(2) Effect of subsection.--Under no circumstances shall 
     application of this section result in an applicant for 
     approval of a drug under section 505(j) being enabled to 
     commercially market the drug to the exclusion of a subsequent 
     applicant for approval of a drug under section 505(j) for 
     more than 180 days.''.

     SEC. 10. 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 appropriate committees of 
     Congress, by 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.

[[Page S10818]]

       (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. 11. 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), 4(b)(2), 8, 
     and 9) 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), and (n) as subsections (b), (a), (g), (h), 
     (m), (l), (i), (j), and (k), 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 (1)), by striking ``subsection (a) or (c)'' and 
     inserting ``subsection (b) or (c)''; and
       (5) in subsection (g) (as redesignated by paragraph (1)), 
     by striking ``subsection (a) or (b)'' and inserting 
     ``subsection (b) or (c)''.

  Mr. HATCH. Mr. President, I rise to commend my colleagues Senators 
DeWine and Dodd for their efforts to reauthorize an important piece of 
legislation--the pediatric exclusivity rules. The DeWine-Dodd pediatric 
exclusivity law was passed as part of the Food and Drug Administration 
Modernization Act of 2001. This bill has helped spur a great deal of 
research into pediatric indications for many pharmaceutical products. 
It is a good law.
  I also want to recognize the efforts of Chairman Kennedy and Ranking 
Member Gregg and Senator Frist for their work in moving this through 
the HELP Committee.
  I am offering a technical amendment that I believe will be acceptable 
to all, that clarifies how the pediatric exclusivity provisions work in 
conjunction with certain provisions of the Drug Price Competition and 
Patent Term Restoration Act. Representative Waxman and I were 
instrumental in developing this important 1984 law.
  I have worked with my colleagues, the administration, and interested 
parties to make certain that the 1997 pediatric exclusivity law does 
not act to curtail the incentives of those generic drug manufacturers 
awarded 180 days of exclusivity under the 1984 law because they have 
successfully challenged a patent or have shown that a pioneer drug 
product is not infringed.
  The amendment I offer today helps make clear that a generic firm that 
qualifies for the 180-day patent noninfringement/patent invalidity 
incentives gains just that--180 days, no more, no less.
  I also thank Senator Dodd for agreeing to continue to work to iron 
out some issues as this bill is conferenced with the House. For 
example, we want to work together to make certain the overlap language 
applies to generic drug applications already in the pipeline at FDA. I 
also understand that some may have concerns that certain aspects of 
this language may raise questions with respect to the takings clause. 
It is my hope that the conferees will work to perfect the language.
  I commend Helen Rhee, who has worked on this bill for both her old 
boss, Senator DeWine and her new boss Senator Frist and Deborah Barrett 
of Senator Dodd's office for their work on this bill.
  I also commend the expert staff of the Food and Drug Administration, 
including Melinda Plaisier, Jarilyn DuPont, Liz Dickinson, and Kim 
Dettelbach for their hard work on this legislation.
  I urge my colleagues to work together to reauthorize the DeWine-Dodd 
pediatric bill.
  Mr. FRIST. Mr. President, I rise today to support S. 838, the Best 
Pharmaceuticals for Children Act. In the January 2001 report to 
Congress, the FDA stated that the law that we are reauthorizing today, 
``has done more to generate clinical studies and useful prescribing 
information for the pediatric population than other regulatory or 
legislative process to date.''
  In just the 3 years since the law was implemented, it has made a 
positive difference in the lives of thousands of children. I am pleased 
to be a cosponsor and strong supporter of this highly successful 
program. In the short time that this program has been in existence, FDA 
has issued about 200 written requests for pediatric studies. Companies 
have undertaken over 400 pediatric studies, of which 58 studies have 
been completed, in a wide range of critical therapeutic areas, 
including gastro
esophageal reflux disease, diabetes mellitus, pain, asthma, and 
hypertension. Thirty-seven drugs have been granted pediatric 
exclusivity, and important label changes have either been made, or are 
underway, as a result of pediatric studies.
  For instance, new pediatric dosing information for a new oral 
formulation of midazolam, a medication used to sedate children in 
surgery, now offers an alternative to the injectable form of the drug 
that needs to be directly injected into a child's vein. The studies 
submitted under this pediatric exclusivity law not only resulted in 
this new oral syrup formulation and correct dosing information, but 
also identified a subpopulation of pediatric patients with heart 
disease and pulmonary hypertension who are at higher risk for adverse 
events unless they are given lower doses than other children. A 
pediatric nephrologist from Memphis, TN, prescribed Randitidine, using 
new dosing and labeling information that resulted from this law, to 
neonates who were experiencing health problems due to acid reflux.
  Despite the successes of this law, we did not settle for a straight 
reauthorization. We instead sought to improve this already highly 
successful law. This law provides a funding mechanism to ensure that 
off-patent drugs and certain declined written requests for the study of 
on-patent drugs, for which the Secretary believes there is a continuing 
need for pediatric testing, are studied. It establishes timeframes for 
responding to written requests, timeframes and processes for 
negotiating label changes, and authorizes the Federal Government to 
deem a drug misbranded if the company ultimately disagrees with FDA's 
proposed new drug label. The government could then begin an enforcement 
action under existing authority to seek a court order regarding 
relabeling of the drug.

  We also lift the current restrictions on user fees established under 
the Prescription Drug User Fee Act to include this pediatric testing 
program. By including pediatric testing in the user fee program, the 
FDA will be given additional resources needed to give priority review 
to pediatric testing applications.
  We provide for the public dissemination of summaries of the pediatric 
studies that are submitted so that certain unprotected information will 
be disseminated to pediatricians even before labeling information has 
been finalized.
  I would like to thank Senator Hatch and his staff, Bruce Artim and 
Trish Knight, for their work in drafting language to clarify that this 
pediatric incentive program does not, and is not intended to, preclude 
other incentives, for example, one that provides for a 180-day 
exclusivity period for the first generic drug company that challenges a 
patent. Another important clarification we made in this bill is that 
the pediatric exclusivity program is not intended to prevent generics 
from entering the market solely based on the fact that some or all of 
the pediatric use information may be protected under the pediatric 
exclusivity law. Allowing generic drug companies to market a drug to 
adults, while requiring that any precautions, warnings, or 
contraindication for pediatric use that the Secretary determines to be 
necessary ensures that the safety of children is protected and that the 
intent of two different laws are both met.
  To further ensure that the safety of children in clinical trials is 
protected, this bill requires that the Institute of Medicine conduct a 
review of federal regulations, reports, and research involving children 
and provide recommendations on best practices relating to research 
involving children. This

[[Page S10819]]

builds on an important review and report from the Department of Health 
and Human Services that Senator Kennedy and I worked with Senator 
DeWine and Dodd to include in the Children's Health Act last year.
  While we ensure that the Secretary convenes and consults with the 
Pediatric Advisory Committee, we also ensure that pediatric oncology 
remains a research priority. Twenty written requests have been issued 
so far for oncology drugs, and this bill authorizes the Pediatric 
Oncology Subcommittee to evaluate therapeutic alternatives to treat 
pediatric cancer and provide recommendations and guidance to ensure 
children with cancer having timely access to the most promising new 
cancer therapies.
  I would like to thank my colleagues, Senators Dodd, DeWine, and 
Kennedy for their relentless effort to create such a strong bill. We 
have worked hard to make major improvements to an already highly 
successful law. I would like to thank Senators Collins and Bond for 
their early support and for helping to draft language to ensure that 
drugs used in the neonate population are studied, when safely and 
ethically appropriate. I also appreciate the support of Senators Gregg, 
Mikulski, Jeffords, Murray, Clinton, Bingaman, and Wellstone for this 
bill and for their help in improving this already highly successful 
pediatric testing law.
  I would also like to thank Helen Rhee on my staff and Debra Barrett 
from Senator Dodd's staff for their tireless dedication and effort to 
help us bring so many Members from across the aisle and off the Hill 
together to pass this legislation. Finally, I would like to thank 
Elaine Holland Vining with the American Academy of Pediatrics, Mark 
Isaac and Natasha Bilimoria with the Elizabeth Glaser Pediatric AIDS 
Foundation, and Jeanne Ireland, Christie Onoda, and Stephanie Sikora 
from Senator Dodd's office for their expertise and guidance in drafting 
this bill. Vince Ventimiglia from Senator Gregg's staff, Christina Ho 
from Senator Clinton's staff, and David Dorsey, David Nexon, and Paul 
Kim from Senator Kennedy's office also deserve much credit for 
negotiating and bringing this bill to final passage today.


                           Amendment No. 1905

  The amendment (No. 1905) was agreed to.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  The committee amendment in the nature of a substitute, as amended was 
agreed to.
  The bill (S. 838), as amended, was read the third time and passed.

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