[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.
____________________