[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.

[[Page H11571]]

                              {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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