[Congressional Record Volume 147, Number 176 (Tuesday, December 18, 2001)]
[House]
[Pages H10200-H10212]
From the Congressional Record Online through the 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 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
[[Page H10201]]
``(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 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
[[Page H10202]]
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.''.
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:
[[Page H10203]]
``(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.
(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
[[Page H10204]]
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.
(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
[[Page H10205]]
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 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,
[[Page H10206]]
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 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
[[Page H10207]]
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 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
[[Page H10208]]
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.
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
[[Page H10209]]
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 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).
[[Page H10210]]
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).
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
[[Page H10211]]
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.
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 this research gap. We also need to provide
[[Page H10212]]
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.
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