[Congressional Record Volume 149, Number 168 (Wednesday, November 19, 2003)]
[House]
[Pages H11567-H11572]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PEDIATRIC RESEARCH EQUITY ACT OF 2003
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
Senate bill (S. 650) to amend the Federal Food, Drug, and Cosmetic Act
to authorize the Food and Drug Administration to require certain
research into drugs used in pediatric patients.
The Clerk read as follows:
S. 650
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 ``Pediatric Research Equity
Act of 2003''.
SEC. 2. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
PRODUCTS.
(a) In General.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
amended by inserting after section 505A the following:
``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND
BIOLOGICAL PRODUCTS.
``(a) New Drugs and Biological Products.--
``(1) In general.--A person that submits an application (or
supplement to an application)--
``(A) under section 505 for a new active ingredient, new
indication, new dosage form, new dosing regimen, or new route
of administration; or
``(B) under section 351 of the Public Health Service Act
(42 U.S.C. 262) for a new active ingredient, new indication,
new dosage form, new dosing regimen, or new route of
administration;
shall submit with the application the assessments described
in paragraph (2).
``(2) Assessments.--
``(A) In general.--The assessments referred to in paragraph
(1) shall contain data, gathered using appropriate
formulations for each age group for which the assessment is
required, that are adequate--
``(i) to assess the safety and effectiveness of the drug or
the biological product for the claimed indications in all
relevant pediatric subpopulations; and
``(ii) to support dosing and administration for each
pediatric subpopulation for which the drug or the biological
product is safe and effective.
``(B) Similar course of disease or similar effect of drug
or biological product.--
``(i) In general.--If the course of the disease and the
effects of the drug are sufficiently similar in adults and
pediatric patients, the Secretary may conclude that pediatric
effectiveness can be extrapolated from adequate and well-
controlled studies in adults, usually supplemented with other
information obtained in pediatric patients, such as
pharmacokinetic studies.
``(ii) Extrapolation between age groups.--A study may not
be needed in each pediatric age group if data from 1 age
group can be extrapolated to another age group.
``(3) Deferral.--On the initiative of the Secretary or at
the request of the applicant, the Secretary may defer
submission of some or all assessments required under
paragraph (1) until a specified date after approval of the
drug or issuance of the license for a biological product if--
``(A) the Secretary finds that--
``(i) the drug or biological product is ready for approval
for use in adults before pediatric studies are complete;
``(ii) pediatric studies should be delayed until additional
safety or effectiveness data have been collected; or
``(iii) there is another appropriate reason for deferral;
and
``(B) the applicant submits to the Secretary--
``(i) certification of the grounds for deferring the
assessments;
``(ii) a description of the planned or ongoing studies; and
``(iii) evidence that the studies are being conducted or
will be conducted with due diligence and at the earliest
possible time.
``(4) Waivers.--
``(A) Full waiver.--On the initiative of the Secretary or
at the request of an applicant, the Secretary shall grant a
full waiver, as appropriate, of the requirement to submit
assessments for a drug or biological product under this
subsection if the applicant certifies and the Secretary finds
that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
is so small or the patients are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in all
pediatric age groups; or
``(iii) the drug or biological product--
``(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients; and
``(II) is not likely to be used in a substantial number of
pediatric patients.
``(B) Partial waiver.--On the initiative of the Secretary
or at the request of an applicant, the Secretary shall grant
a partial waiver, as appropriate, of the requirement to
submit assessments for a drug or biological product under
this subsection with respect to a specific pediatric age
group if the applicant certifies and the Secretary finds
that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in that
age group;
``(iii) the drug or biological product--
``(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
``(II) is not likely to be used by a substantial number of
pediatric patients in that age group; or
``(iv) the applicant can demonstrate that reasonable
attempts to produce a pediatric formulation necessary for
that age group have failed.
``(C) Pediatric formulation not possible.--If a waiver is
granted on the ground that it is not possible to develop a
pediatric formulation, the waiver shall cover only the
pediatric groups requiring that formulation.
``(D) Labeling requirement.--If the Secretary grants a full
or partial waiver because there is evidence that a drug or
biological product would be ineffective or unsafe in
pediatric populations, the information shall be included in
the labeling for the drug or biological product.
``(b) Marketed Drugs and Biological Products.--
``(1) In general.--After providing notice in the form of a
letter and an opportunity for written response and a meeting,
which may include an advisory committee meeting, the
Secretary may (by order in the form of a letter) require the
holder of an approved application for a drug under section
505 or the holder of a license for a biological product under
section 351 of the Public Health Service Act (42 U.S.C. 262)
to submit by a specified date the assessments described in
subsection (a)(2) if the Secretary finds that--
``(A)(i) the drug or biological product is used for a
substantial number of pediatric patients for the labeled
indications; and
``(ii) the absence of adequate labeling could pose
significant risks to pediatric patients; or
``(B)(i) there is reason to believe that the drug or
biological product would represent a meaningful therapeutic
benefit over existing therapies for pediatric patients for 1
or more of the claimed indications; and
``(ii) the absence of adequate labeling could pose
significant risks to pediatric patients.
``(2) Waivers.--
``(A) Full waiver.--At the request of an applicant, the
Secretary shall grant a full waiver, as appropriate, of the
requirement to
[[Page H11568]]
submit assessments under this subsection if the applicant
certifies and the Secretary finds that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed); or
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in all
pediatric age groups.
``(B) Partial waiver.--At the request of an applicant, the
Secretary shall grant a partial waiver, as appropriate, of
the requirement to submit assessments under this subsection
with respect to a specific pediatric age group if the
applicant certifies and the Secretary finds that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in that
age group;
``(iii)(I) the drug or biological product--
``(aa) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
``(bb) is not likely to be used in a substantial number of
pediatric patients in that age group; and
``(II) the absence of adequate labeling could not pose
significant risks to pediatric patients; or
``(iv) the applicant can demonstrate that reasonable
attempts to produce a pediatric formulation necessary for
that age group have failed.
``(C) Pediatric formulation not possible.--If a waiver is
granted on the ground that it is not possible to develop a
pediatric formulation, the waiver shall cover only the
pediatric groups requiring that formulation.
``(D) Labeling requirement.--If the Secretary grants a full
or partial waiver because there is evidence that a drug or
biological product would be ineffective or unsafe in
pediatric populations, the information shall be included in
the labeling for the drug or biological product.
``(3) Relationship to other pediatric provisions.--
``(A) No assessment without written request.--No assessment
may be required under paragraph (1) for a drug subject to an
approved application under section 505 unless--
``(i) the Secretary has issued a written request for a
related pediatric study under section 505A(c) of this Act or
section 409I of the Public Health Service Act (42 U.S.C.
284m);
``(ii)(I) if the request was made under section 505A(c)--
``(aa) the recipient of the written request does not agree
to the request; or
``(bb) the Secretary does not receive a response as
specified under section 505A(d)(4)(A); or
``(II) if the request was made under section 409I of the
Public Health Service Act (42 U.S.C. 284m)--
``(aa) the recipient of the written request does not agree
to the request; or
``(bb) the Secretary does not receive a response as
specified under section 409I(c)(2) of that Act; and
``(iii)(I) the Secretary certifies under subparagraph (B)
that there are insufficient funds under sections 409I and 499
of the Public Health Service Act (42 U.S.C. 284m, 290b) to
conduct the study; or
``(II) the Secretary publishes in the Federal Register a
certification that certifies that--
``(aa) no contract or grant has been awarded under section
409I or 499 of the Public Health Service Act (42 U.S.C. 284m,
290b); and
``(bb) not less than 270 days have passed since the date of
a certification under subparagraph (B) that there are
sufficient funds to conduct the study.
``(B) No agreement to request.--Not later than 60 days
after determining that no holder will agree to the written
request (including a determination that the Secretary has not
received a response specified under section 505A(d) of this
Act or section 409I of the Public Health Service Act (42
U.S.C. 284m), the Secretary shall certify whether the
Secretary has sufficient funds to conduct the study under
section 409I or 499 of the Public Health Service Act (42
U.S.C. 284m, 290b), taking into account the prioritization
under section 409I.
``(c) Meaningful Therapeutic Benefit.--For the purposes of
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a)
and paragraphs (1)(B)(i) and (2)(B)(iii)(I)(aa) of subsection
(b), a drug or biological product shall be considered to
represent a meaningful therapeutic benefit over existing
therapies if the Secretary estimates that--
``(1) if approved, the drug or biological product would
represent a significant improvement in the treatment,
diagnosis, or prevention of a disease, compared with marketed
products adequately labeled for that use in the relevant
pediatric population; or
``(2) the drug or biological product is in a class of
products or for an indication for which there is a need for
additional options.
``(d) Submission of Assessments.--If a person fails to
submit an assessment described in subsection (a)(2), or a
request for approval of a pediatric formulation described in
subsection (a) or (b), in accordance with applicable
provisions of subsections (a) and (b)--
``(1) the drug or biological product that is the subject of
the assessment or request may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not
be subject to action under section 303); but
``(2) the failure to submit the assessment or request shall
not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section 505(e);
or
``(B) to revoke the license for a biological product under
section 351 of the Public Health Service Act (42 U.S.C. 262).
``(e) Meetings.--Before and during the investigational
process for a new drug or biological product, the Secretary
shall meet at appropriate times with the sponsor of the new
drug or biological product to discuss--
``(1) information that the sponsor submits on plans and
timelines for pediatric studies; or
``(2) any planned request by the sponsor for waiver or
deferral of pediatric studies.
``(f) Scope of Authority.--Nothing in this section provides
to the Secretary any authority to require a pediatric
assessment of any drug or biological product, or any
assessment regarding other populations or uses of a drug or
biological product, other than the pediatric assessments
described in this section.
``(g) Orphan Drugs.--Unless the Secretary requires
otherwise by regulation, this section does not apply to any
drug for an indication for which orphan designation has been
granted under section 526.
``(h) Integration With Other Pediatric Studies.--The
authority under this section shall remain in effect so long
as an application subject to this section may be accepted for
filing by the Secretary on or before the date specified in
section 505A(n).''.
(b) Conforming Amendments.--
(1) Section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(1)) is amended in the second
sentence--
(A) by striking ``and (F)'' and inserting ``(F)''; and
(B) by striking the period at the end and inserting ``, and
(G) any assessments required under section 505B.''.
(2) Section 505A(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a(h)) is amended--
(A) in the subsection heading, by striking ``Regulations''
and inserting ``Pediatric Research Requirements''; and
(B) by striking ``pursuant to regulations promulgated by
the Secretary'' and inserting ``by a provision of law
(including a regulation) other than this section''.
(3) Section 351(a)(2) of the Public Health Service Act (42
U.S.C. 262(a)(2)) is amended--
(A) by redesignating subparagraph (B) as subparagraph (C);
and
(B) by inserting after subparagraph (A) the following:
``(B) Pediatric studies.--A person that submits an
application for a license under this paragraph shall submit
to the Secretary as part of the application any assessments
required under section 505B of the Federal Food, Drug, and
Cosmetic Act.''.
SEC. 3. TECHNICAL AND CONFORMING AMENDMENTS.
(a) Abbreviated New Drug Application.--Section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is
amended in subparagraphs (A) and (B) of subsection (b)(2) and
subparagraphs (A) and (B) of subsection (c)(2) by striking
``505(j)(4)(B)'' and inserting ``505(j)(5)(B)''.
(b) Pediatric Advisory Committee.--
(1) Section 505A(i)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a(i)(2)) is amended by striking
``Advisory Subcommittee of the Anti-Infective Drugs'' each
place it appears.
(2) Section 14 of the Best Pharmaceuticals for Children Act
(42 U.S.C. 284m note; Public Law 107-109) is amended--
(A) in the section heading, by striking ``PHARMACOLOGY'';
(B) in subsection (a), by striking ``(42 U.S.C. 217a),''
and inserting (42 U.S.C. 217a) or other appropriate
authority,'';
(C) in subsection (b)--
(i) in paragraph (1), by striking ``and in consultation
with the Director of the National Institutes of Health''; and
(ii) in paragraph (2), by striking ``and 505A'' and
inserting ``505A, and 505B''; and
(D) by striking ``pharmacology'' each place it appears and
inserting ``therapeutics''.
(3) Section 15(a)(2)(A) of the Best Pharmaceuticals for
Children Act (115 Stat. 1419) is amended by striking
``Pharmacology''.
(4) Section 16(1)(C) of the Best Pharmaceuticals for
Children Act (21 U.S.C. 355a note; Public Law 107-109) is
amended by striking ``Advisory Subcommittee of the Anti-
Infective Drugs''.
(5) Section 17(b)(1) of the Best Pharmaceuticals for
Children Act (21 U.S.C. 355b(b)(1)) is amended in the second
sentence by striking ``Advisory Subcommittee of the Anti-
Infective Drugs''.
(6) Paragraphs (8), (9), and (11) of section 409I(c) of the
Public Health Service Act (42 U.S.C. 284m(c)) are amended by
striking ``Advisory Subcommittee of the Anti-Infective
Drugs'' each place it appears.
SEC. 4. EFFECTIVE DATE.
(a) In General.--Subject to subsection (b), this Act and
the amendments made by this Act take effect on the date of
enactment of this Act.
(b) Applicability to New Drugs and Biological Products.--
[[Page H11569]]
(1) In general.--Subsection (a) of section 505B of the
Federal Food, Drug, and Cosmetic Act (as added by section 2)
shall apply to an application described in paragraph (1) of
that subsection submitted to the Secretary of Health and
Human Services on or after April 1, 1999.
(2) Waivers and deferrals.--
(A) Waiver or deferral granted.--If, with respect to an
application submitted to the Secretary of Health and Human
Services between April 1, 1999, and the date of enactment of
this Act, a waiver or deferral of pediatric assessments was
granted under regulations of the Secretary then in effect,
the waiver or deferral shall be a waiver or deferral under
subsection (a) of section 505B of the Federal Food, Drug, and
Cosmetic Act, except that any date specified in such a
deferral shall be extended by the number of days that is
equal to the number of days between October 17, 2002, and the
date of enactment of this Act.
(B) Waiver and deferral not granted.--If, with respect to
an application submitted to the Secretary of Health and Human
Services between April 1, 1999, and the date of enactment of
this Act, neither a waiver nor deferral of pediatric
assessments was granted under regulations of the Secretary
then in effect, the person that submitted the application
shall be required to submit assessments under subsection
(a)(2) of section 505B of the Federal Food, Drug, and
Cosmetic Act on the date that is the later of--
(i) the date that is 1 year after the date of enactment of
this Act; or
(ii) such date as the Secretary may specify under
subsection (a)(3) of that section;
unless the Secretary grants a waiver under subsection (a)(4)
of that section.
(c) No Limitation of Authority.--Neither the lack of
guidance or regulations to implement this Act or the
amendments made by this Act nor the pendency of the process
for issuing guidance or regulations shall limit the authority
of the Secretary of Health and Human Services under, or defer
any requirement under, this Act or those amendments.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each
will control 20 minutes.
The Chair recognizes the gentleman from Florida (Mr. Bilirakis).
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and to insert extraneous material on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
{time} 1530
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of S. 650, the Pediatric
Research Equity Act. This bill gives the Food and Drug Administration
new statutory authority to require certain pediatric tests, to require
certain research into drugs used for pediatric patients, and it
provides for appropriate enforcement of the requirement to submit
timely pediatric assessments.
As chairman of the Energy and Commerce Subcommittee on Health, I have
been a long-time supporter of pediatric research efforts. To that end,
it is important that the FDA has the authority that it needs to require
pediatric studies and also information for drugs and biological
products in cases where the needed information is not generated by
using existing incentive and funding mechanisms. S. 650 will provide
that authority.
I think it is appropriate to express appreciation to Senator DeWine
for this piece of legislation and to the gentleman from Ohio (Mr.
Brown), the gentleman from California (Mr. Waxman), the gentlewoman
from California (Ms. Eshoo) and so many others who have shown concern
in this regard and, of course, join us here today.
I urge my colleagues to support the bill that the Senate has passed.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may
consume.
I would like to thank the gentleman from California (Mr. Waxman), the
gentlewoman from California (Ms. Eshoo), the gentleman from
Pennsylvania (Mr. Greenwood) and the gentleman from Michigan (Mr.
Stupak) for their leadership on the important issue of prescription
drug research for children. The legislation we consider today is in
large part the product of their hard work and their good work.
The FDA requires drug manufacturers to verify the safety and
effectiveness of a new medicine before it can be sold in our country.
But because most research has been done on adults, new medicines that
are safe and effective in grownups may not be safe and effective when
used in children. That is why we enacted legislation rewarding safety
and efficacy testing that focuses on children. Drug companies that
voluntarily conduct this testing are granted what amounts to a patent
extension on the pediatric use of their medicines. Though progress has
been made, an article published last year in the New England Journal of
Medicine confirmed that fully 60 percent of drugs coming to the market
remain unstudied and unlabeled for use in children. FDA's Pediatric
Rule addressed that concern, but a Federal judge struck it down last
year because, according to those judges, the agency lacked sufficient
statutory authority.
The legislation today before us corrects that deficiency and codifies
the Pediatric Rule. S. 650 requires pediatric testing as a condition of
new drug approval every time. It authorizes responsible exceptions,
though, deferrals and waivers when these actions would be determined to
serve the interests of patients. This approach will ensure that most
medicines are testified for safety and effectiveness in children before
they hit the market. It gives the FDA the flexibility to move drugs to
market when testing is unwarranted or impossible or would hold up a
drug important for adult patients.
I have, Mr. Speaker, one important concern with this otherwise
laudable legislation. It relates to a controversial provision added by
the other body which terminates the testing requirement when the
pediatric marketing exclusivity provision expires. There is no policy
justification for this change. If it is responsible to require
pediatric testing today, it will be no less responsible to do so after
the government subsidy for pediatric testing has expired. America's
children, pure and simple, are not served by this language. The only
ones who benefit again are drugmakers. It has been a really good week
for drugmakers in this country. As good as this bill is, they get a
benefit they do not deserve. They also get a benefit later in the week
if this House passes the Medicare bill to the tune of about $140
billion more in profits on a bill that, frankly, they and the
Republican majority and President Bush sat down and wrote to help the
drug industry and the insurance industry.
This provision in our bill is objectionable on procedural grounds,
also. The other body acted months ago, but the Committee on Energy and
Commerce did not schedule a markup that would have permitted us to
debate and vote on the sunset provision and consider related issues
important especially to the gentleman from Michigan (Mr. Stupak) and to
other Members. I hope this process will not become the model for health
legislation in this House.
Having said that, the bill is an important step forward in children's
health. America's leading children's health advocates also strongly
support the Pediatric Rule. The American Academy of Pediatrics called
it an essential tool. The Elizabeth Glaser Pediatric AIDS Foundation
said it will safeguard children by taking the guesswork out of
children's medicine.
I hope Members will join me in voting to send the Pediatric Research
Equity Act to the White House.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentlewoman
from California (Ms. Eshoo), one of the authors of this legislation.
Ms. ESHOO. I thank the distinguished ranking member for yielding me
this time.
Mr. Speaker, I rise today in support of S. 650, the Pediatric
Research Equity Act. As the Democratic sponsor of the House version of
this legislation, along with the gentleman from Pennsylvania (Mr.
Greenwood), I am very excited that this important bipartisan
legislation is being considered before Congress departs and closes shop
before the end of this year.
In the last session, the Congress took an important step toward
increasing drug safety for children by reauthorizing the Best
Pharmaceuticals for
[[Page H11570]]
Children Act, a bill that I also cosponsored with the gentleman from
Pennsylvania (Mr. Greenwood). The law provided 6 months of marketing
exclusivity for prescription drug manufacturers who undertake the
costly, but very necessary, task of testing drugs for safety and
efficacy in children. Prior to its enactment, there was little if any
information on how drugs affected children. That surprised a lot of
people. Most people assumed that the process was really very different.
Doctors were cutting adult pills in half, hoping they would work in
children, often with life-threatening results. In the years since its
passage, the Best Pharmaceuticals for Children Act has yielded
significant and lifesaving dosing and efficacy information for
prescription drugs for children, and this law continues to work today
and work very well. Anyone that is a parent can appreciate the success
this bill has had in protecting children.
Despite this success, there are times when the Food and Drug
Administration needs additional pediatric clinical data on a drug.
Since the passage of the Best Pharmaceuticals for Children Act, a court
struck down an important regulation crafted by the FDA that provided a
framework for requiring drug manufacturers to perform clinical trials
in pediatric populations when the Agency believed they were absolutely
necessary. The court argued that the Congress had not given the FDA
this authority, effectively tying the Agency's hands with respect to
providing safer drugs for children.
In response to this court decision, the gentleman from Pennsylvania
(Mr. Greenwood) and I introduced the Pediatric Research Equity Act,
which specifically gives the FDA the authority that the court struck
down, the authority to require prescription drug manufacturers to
perform necessary tests for our children. The FDA's gold standard has
protected American consumers and America's children for decades. The
Congress has to take this step to equip the FDA with the resources and
the authority it needs to continue this exceptional performance.
This bill has very important support. Amongst that honor roll of
support is the American Academy of Pediatrics which has worked so well
and so closely with us, and we want to thank them for that; the
Elizabeth Glaser Pediatric AIDS Foundation; the pharmaceutical industry
and other groups that are dedicated to providing safe and effective
treatments to children. In years past, some have been critical of our
work to increase drug safety for children, charging that it is really
more about providing incentives to drug companies than it is about
children. This effort, as with our work on the Best Pharmaceuticals for
Children Act, has always been about making drug treatments safer and
more effective for children. And while I understand that the process
for moving this bill forward has not been perfect, as so many things
around here are not, the underlying bill and the goals it contains are
ones that every single Member of the House can and should support.
Finally, Mr. Speaker, I want to offer my unending gratitude to our
committee staff for their work on moving this bill forward. In
particular, I would like to thank Patrick Ronan with the majority for
his help and John Ford on the minority side for his assistance and his
advice. As always, it has been invaluable. I also wish to recognize the
leadership of the gentleman from Florida (Mr. Bilirakis) and always to
my partner, the gentleman from Pennsylvania (Mr. Greenwood). I think we
have been able to get some really important things done. I wish to
recognize the inspiration of Dr. Phil Pizzo, dean of the Stanford
Medical School, a pediatrician himself. And last but never least, Anne
Wilson, my legislative director. This legislation becomes her swan
song. She goes off to the private sector to do some really great work,
but this is one of the signature pieces that she has really worked so
hard on. I salute her for it.
I urge my colleagues to vote ``yes'' on S. 650, the Pediatric
Research Equity Act, and my thanks to everyone that have been partners
in this what I think has been a noble and important undertaking.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Pennsylvania (Mr. Greenwood).
Mr. GREENWOOD. I thank the gentleman for yielding me this time.
Mr. Speaker, I rise in strong support of S. 650, the Pediatric
Research Equity Act. This legislation was passed by the Senate by
unanimous consent on July 23. Earlier this year, along with the
gentlewoman from California (Ms. Eshoo) and the gentlewoman from Ohio
(Ms. Pryce), I introduced this legislation in the House. Both of these
Members have been leaders on trying to get this legislation enacted
into law.
Children, their physicians, and their parents need to know that the
drugs they use are safe and effective. Just over a year ago, a Federal
court struck down the 1998 Pediatric Rule on the grounds that Congress
had not explicitly given the authority to require that these much-
needed pediatric studies be done. The Pediatric Research Equity Act
creates a critical safety net for children by restoring this authority.
Before it was struck down, the Pediatric Rule led to invaluable
pediatric safety and dosing information. The rule places children on
equal therapeutic footing with adults by ensuring that medicines coming
into the marketplace will be labeled for pediatric use and be available
in formulations such as liquids or chewable tablets that children can
take.
This legislation will also ensure that there will be no delay in the
approval of drugs for adult use by allowing pediatric testing to be
deferred until after approval if these studies would delay the
availability of the product for adults.
Mr. Speaker, this legislation complements the Best Pharmaceuticals
for Children Act which Congress passed 2 years ago. That law recognizes
the importance of pediatric drug testing by offering an incentive to
companies who conduct tests of drugs on children. However, certain
medicines are not captured by the Best Pharmaceuticals for Children Act
and, therefore, will be left unstudied for pediatric use without the
rule. Both the BPCA and the rule are needed as a strong, two-prong
approach to ensure that drugs are appropriately studied and labeled for
infants, children and adolescents.
Mr. Speaker, this legislation was discharged from the Committee on
Energy and Commerce. Many of us on both sides of the aisle had hoped
that the committee would consider this through normal order as there
were issues that both sides wanted to make about the legislation. But
due to the Medicare and the energy conferences and the limitations
those bills have created in the committees, it was necessary for this
legislation to be discharged. While this was not the perfect process, I
urge my colleagues to join our colleagues in the Senate and the 25
children's health groups, including the American Academy of Pediatrics
and the Elizabeth Glaser Pediatric AIDS Foundation, who support this
legislation. In their own words, quote, we cannot overstate the
extraordinary contribution this legislation will make to children's
health.
I would also like to thank my staff member Alan Eisenberg who has
worked very hard for a long period on this issue. I urge passage of the
legislation.
Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman
from Michigan (Mr. Stupak) who has been an absolute leader with a great
understanding on these very complicated drug issues.
Mr. STUPAK. I thank the gentleman for yielding me this time.
Mr. Speaker, the pediatric research equity bill is not a bad bill. I
agree with the premise of the bill. As the ranking member of the
Subcommittee on Health said, it is unfortunate that we have not had a
hearing on this bill, we have not had a chance to mark it up, we have
not had a chance to amend it. Because I would wish that Congress would
stop for a minute and look at this bill before we make another fatal
mistake when we deal with pharmaceuticals dealing with young people. As
the other speakers said, it is necessary to test and do proper labeling
on drugs before we give them to children. We need to know, I think is
what the chairman said, all the ramifications before we give young
people drugs. This bill goes halfway. This bill only goes halfway. This
Congress should not allow the continuation of the practice of
pharmaceutical companies being able to develop drugs but not put on
proper labeling.
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{time} 1545
Or when it is time to change the label, to expeditiously change the
label, as the other speakers have said, we have been cutting pills in
half thinking for young people half a pill is better than a full pill.
When they do this testing, when it comes time to label, doctors,
families, patients need to know how should the drug be used in
dispense. What is the proper dosage for young people? What duration of
time should the pill be taken and how often? What are the side effects
of the use of this drug? These are the questions that are required for
proper use and labeling, but yet it is not required in this legislation
nor was it required in the pharmaceutical act of 2002.
So before a drug is marketed, it should be properly labeled with all
the necessary information to be used in pediatric patients. Doctors and
patients and families have no idea on how to administer drugs or what
the effect will be on young people without proper labeling. All I am
saying is we should have had an opportunity to amend this legislation
to make sure before a patent is extended, before a drug is given for
pediatric patients, that the proper labeling is done and made available
to doctors, patients, and their families. It is marketed and given to
children before we know what the effects are on young people.
As we said earlier, the Best Pharmaceutical Act of 2002 did require a
strengthening of labeling requirements, but it did not mandate proper
labeling before marketing of these drugs. While the FDA can misbrand a
drug for improper labeling, it has never used the enforcement power it
has. It has never used the enforcement power granted to it by Congress.
As a result, case after case, the pharmaceutical companies have been
granted patent extensions and then not gone through with the labeling
of the drugs for years. And these drugs were not labeled misbranded by
the FDA. Between 1997 and 2002, the year of the Best Pharmaceutical Act
for children, the average time for labeling was 9 months after the
extension of that patent. Now based upon the Best Pharmaceutical Act of
2002, it is still 5 months after the drug has been used in the
marketplace. How on God's green Earth can we stand here and say we will
label the proper use of drugs after it is marketed? Five months, that
is what it is right now. Some of them are a year. The average is 5
months.
If we would have had a chance to have this before our committee, we
could at least have offered some amendments. To uphold the true
intention of this legislation and the true intent of the Best
Pharmaceutical Act is to make sure we have labeling before drugs are
put on the marketplace and not after, requiring, and not suggesting,
that the Secretary of HHS label drugs as misbranded if companies fail
to test and label these drugs for use in children.
I would like to see this legislation defeated. That will not happen
here today. But once again, the Congress of the United States has
punted an opportunity to protect our children. We once again said we
will allow drugs to be used; we will worry about the side effects on
young people after. There is no reason why we could not mandate proper
labeling before. And if my colleagues read the language of the bill, it
says may, the Secretary may.
We have asked and we have talked to the sponsor in the Senate and we
have talked to others. We said why can they not just make it mandatory,
label before they market and use in young people? Once again, Congress
is avoiding its responsibility to protect the health, safety, and
welfare of our young people. The ideas behind this legislation are
great. The intent is great, but we have to follow it through. And we
have all sat in committees and heard the stories of young people
receiving drugs that were improperly used or administered that were not
to be used for young people. We find out after the fact, after the drug
has been used in the mainstream of commerce and being used by
physicians.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as she may consume to
the gentlewoman from Ohio (Ms. Pryce).
Ms. PRYCE of Ohio. Mr. Speaker, I thank the gentleman for yielding me
this time and for his strong leadership on this measure.
Mr. Speaker, today is a great day for America's children. Today we
will stand with the President of the United States on an extraordinary
piece of legislation, legislation that will have the effect of
dramatically improving the health and well-being of our Nation's
children.
About this time last year, my good friend and former Member, Connie
Morella, and I introduced this legislation to put into law the
Pediatric Rule, a rule that required drug companies to conduct safety
tests of adult medicines that were likely to be given to children. We
introduced that bill even before a U.S. district court struck down that
rule finding that the FDA did not have the authority to enforce it. We
felt then, as we do now, that this rule must be strengthened and
codified to ensure advancements and effectiveness in medicines that we
give to our children.
In light of the district court's ruling, Members of this body renewed
our efforts this year to see that the rule would be put into law for
good. With the hard work of the gentleman from Pennsylvania (Mr.
Greenwood) and the gentlewoman from California (Ms. Eshoo) and the
blessings of the gentleman from Louisiana (Chairman Tauzin) and the
gentleman from Florida (Chairman Bilirakis) and the gentleman from Ohio
(Mr. Brown), ranking member, we have found ourselves today ready to
move forward.
The rule is so important for a few very simple reasons. Many people
wrongly assume that children's bodies are just smaller versions of
adult bodies. That is just not the case. Simply reducing the dosage of
medicine for the treatment of a child is not always effective and is
definitely not always safe. By protecting this rule, the Pediatric
Rule, and continuing to provide incentives for testing medicines for
kids, we will give doctors the information they need to provide our
children with the best quality health care.
Mr. Speaker, when I told my constituents at Children's Hospital in
Columbus, Ohio, that this legislation would be up for consideration
today, I was greeted with elation. Those who care for and treat our
children want the very best for them. They know what they need to
deliver the very best. They need the Pediatric Rule and believe it is
critical to preserving the long-term health and safety of our kids.
That is exactly what this bill does. I am proud to be a part of making
these safeguards permanent and this bill a reality.
Mr. Speaker, I urge my colleagues to join me in strengthening the
health of our children by adopting this legislation. Every pediatrician
will rest easier. I am certain that every parent will.
Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman
from California (Mr. Waxman).
Mr. WAXMAN. Mr. Speaker, I rise in support of the Pediatric Research
Equity Act, and I urge other Members to support it as well. This
legislation has been a long time in coming. Physicians have known for
decades that failing to test drugs in children could have deadly
consequences.
It was not until the late 1990s that Congress and the FDA finally
acted to ensure testing of drugs in children. In 1997 Congress enacted
a bill giving pharmaceutical companies generous financial incentives
for voluntarily conducting pediatric studies. A year later, FDA
finalized a regulation known as the Pediatric Rule, requiring companies
to conduct studies in children for important or widely used drugs, and
that regulation was regarded by both the FDA and by physician and
patient groups as essential because the financial incentives still left
many important drugs and many age groups unstudied. Unfortunately, the
Pediatric Rule was struck down by a district court last year. I believe
the case was wrongly decided and that FDA had adequate authority; but
we need to codify the rule now, as this bill would do, in order to
provide children with the strongest protection of their right to
receive medicines that are as safe and as effective as the medicines
given to adults.
While I strongly support this bill, there is one provision I do not
support. The bill contains a sunset provision which will repeal in 5
years the protections for children that this bill is designed to
provide. I regret this bill did
[[Page H11572]]
not go through the committee allowing us the opportunity to strike this
provision. Sunsetting the bill is simply bad policy. There is no
serious medical or public health argument that it would enhance the
health of American children to repeal this law in 5 years. Certainly no
one makes the argument that the rules regarding testing of drugs in
adults need to be reassessed every 5 years.
Since the sunset provision is not based on improving the public
health, why is it in the bill? I have been told that the law giving
companies financial incentives for conducting pediatric studies sunsets
every 5 years, so this bill should too. But the financial incentives
bill raises very different concerns. Those incentives extend drug
company monopolies on popular drugs, which in turn raises the price of
those drugs for all Americans.
The Congress has an obligation to reassess the size of the incentives
periodically to make sure that the cost in higher drug prices is worth
the benefit being gained.
There is no similar reason to reassess the Pediatric Rule, and I am
very concerned that by sunsetting the two bills together, the Congress
will be put in a position where reauthorization of the Pediatric Rule
is held hostage to reauthorization of the incentives.
The fact that we have been denied the opportunity to strike the
sunset is unfortunate. Similarly, I regret that the gentleman from
Michigan (Mr. Stupak) was denied the opportunity to offer his amendment
which addresses an extremely serious issue. I strongly support his
amendment and would have liked to have voted for it in committee.
Nevertheless, despite my concern with the process, I will vote for
this bill. It is urgent that we pass this legislation as quickly as
possible. Every day that we do not act to put the Pediatric Rule back
into effect, we run an additional risk that the health of American
children will be compromised.
For more than 40 years, the Food and Drug Act has offered a guarantee
to adult Americans that their drugs will be safe and effective. It is
time we assured our children of the same guarantee.
This bill will also assure that all contact lens care products will
be regulated as device accessories.
Mr. DINGELL. Mr. Speaker, I support S. 650, the ``Pediatric Research
Equity Act of 2003.'' This bill will make clear that the Food and Drug
Administration (FDA) has the authority to require testing for drugs
that are administered to children in appropriate cases. This
legislation will effectively moot pending litigation. Last year, a
Federal district court held that FDA lacked statutory authority to
promulgate the pediatric rule. While appeals are pending, this bill
will provide a speedy and certain resolution of that question.
Mr. Speaker, I do want to express my concerns with a provision in
this bill which sunsets FDA's authority on October 1, 2007. Why on
earth should a regulatory authority to protect the health of children
be time limited? There are reasons, none of them good. This date just
happens to coincide with the expiration of a provision of existing law
which provides a financially powerful incentive to drug makers to test
drugs for children. Whatever the perceived merits of the incentive, it
costs consumers a lot of money because it delays generic drug entry
into the market for six months beyond what would normally be the case.
The rule is being tied to the incentive and that, in my view, is just
plain wrong.
We should have had an opportunity to debate and offer amendments to
improve S. 650, but this bill is being brought to the floor without
being reported or otherwise considered by the Committee on Energy and
Commerce. This is an unnecessary and unwise bypass of the committee of
jurisdiction. The health of America's children is too important for us
to avoid careful consideration of matters that affect them. For us to
merely adopt the work product of the Senate is to shirk our duty for
our children. We can do better, and the fact that we did not do better
is unfortunate.
Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time,
and I yield back the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I have no further requests for time, and
I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Ose). The question is on the motion
offered by the gentleman from Florida (Mr. Bilirakis) that the House
suspend the rules and pass the Senate bill, S. 650.
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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