[Congressional Record (Bound Edition), Volume 147 (2001), Part 18]
[Senate]
[Pages 25074-25080]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

  Mr. REID. Madam President, this has been approved by the minority.
  I ask unanimous consent that the Senate proceed to the immediate 
consideration of Calendar No. 271, S. 1789.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The senior assistant bill clerk read as follows:

       A bill (S. 1789) to amend the Federal Food, Drug, and 
     Cosmetic Act to improve the safety and efficacy of 
     pharmaceuticals for children.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. KENNEDY. I congratulate my friend from Connecticut, Senator Dodd, 
and my friend from Ohio, Senator DeWine, for bringing us the Best 
Pharmaceuticals for Children Act. Since 1977, we've had great success 
increasing the number of studies of drugs in children, and it's 
important that we reauthorize pediatric exclusivity to continue this 
success. One improvement in this reauthorization is that section 4 of 
your bill will see to it that, when a drug company declines an FDA 
request to study its patented drug for children, the drug will 
nonetheless be studied for children.
  Mr. DODD. That is correct.
  Mr. KENNEDY. You bill has these studies being conducted by, for 
example, universities, hospitals, contract research organizations, and 
pediatric pharmacology units. The studies will happen after referral to 
the Foundation for the National Institutes of Health, which, if it has 
the money to do so, provides money to the NIH for it to fund the 
studies, or passes it on to the NIH to pay for the studies with money 
that the bill itself authorizes.
  Mr. DeWINE. Yes, that's how the process works.
  Mr. KENNEDY. And after the research is conducted, the results are 
submitted to the Secretary of Health of Human Services. Once the 
Secretary has received the results, the Secretary, through the FDA, 
analyzes the information from the studies and determines what is 
necessary to provide appropriate pediatric labeling of the drug.
  Mf. DODD. Yes, that is what we intend.
  Mr. KENNEDY. So, it is fair to conclude that pediatric research 
conducted by third parties, using a commercially available drug, and 
paid for by the Foundation of the National Institutes of Health or by 
NIH under your bill, will not infringe any patent on the drug and shall 
be considered to be an activity conducted for the purpose of 
development and submission of information to the Secretary of Health 
and Human Services under the Federal Food, Drug, and Cosmetic Act?
  Mr. DeWINE. Yes, I agree with that conclusion.
  Mr. DeWINE. Madam President, I rise today to thank my colleagues for 
supporting and passing the conference report on a bill that Senator 
Dodd and I have been working on for some time. This bill, S. 1789, the 
Best Pharmaceuticals for Children Act, is reauthorization legislation 
designed to ensure that more medicines are tested for children and that 
useful prescribing and dosing information appears on labels.
  Before I say anything else, I'd like to thank Senator Dodd for his 
tireless efforts on behalf of children. He is a true champion for 
children. And, passage of our bill today, is just one more example of 
how he has dedicated so much of his time and energy to protect our 
Nation's kids, our Nation's future.
  Our Best Pharmaceuticals bill is really vital in protecting our 
children when they are sick. This bill will make sure that we test 
drugs for kids on kids. Right now, most drugs are designed and tested 
on and for use by adults. Prescribing medicine for children is 
difficult for a variety of reasons. Proper dosing depends on a child's 
weight and metabolisms. Furthermore, children's bodies grow and change 
quickly. Children also may not give doctors accurate information about 
how medicines are affecting them, making diagnoses difficult, involving 
a large-degree of guess work.
  A recent six-week study in Boston, at two of its most well-respected 
hospitals, found that over that time, 616 prescriptions written for 
children contained errors. Of those, 26 actually harmed children. Of 
the errors that were caught before the medication was administered, 18 
could have been fatal. And, a study in the a recent Journal of the 
American Medical Association, found that medication errors in hospitals 
occur three times more frequently with children than with adults.
  Four years ago, Senator Dodd and I first learned that the vast 
majority of drugs in this country that came on the market every week, 
in fact over 80 percent, had never been formally tested or approved for 
pediatric use and therefore lacked even the most basic labeling 
information regarding dosing recommendations for children. When we 
found that out, we began writing what is now referred to as the 
pediatric exclusivity law. In the three years since that law went into 
effect, the FDA has issued about 200 written requests for pediatric 
studies.
  Companies have undertaken over 400 pediatric studies, of which over 
58 studies have been completed, for a wide range of critical diseases, 
including juvenile diabetes, the problem of pain, asthma, and 
hypertension.
  Thirty-seven drugs have been granted pediatric exclusivity. Some 
studies generated by this incentive have led to essential dosing 
information. Take, for example, the drug, Luvox. Luvox is a drug 
prescribed to treat obsessive-compulsive disorder. Pediatric studies 
performed pursuant to our law have shown inadequate dosing for 
adolescents,

[[Page 25075]]

which resulted in ineffective treatment. The studies also have shown 
that some girls between the ages of eight and 11 were potentially 
overdosed, with levels up to two to three times that which was really 
needed.
  Our Better Pharmaceuticals law has done a great deal of good. We are 
seeing more drugs for children on the market that have a label that 
tells how they can be used, and more basic information for 
pediatricians. So when they look at that little child and they know the 
age of that child and they know the weight of that child, doctors can 
look it up and see exactly what the prescription should be, what the 
dosage should be, what the indicators are for that child. They can do 
that because we have given the pharmaceutical companies an incentive to 
do the research, research they were doing in only 20 percent of the 
cases prior to passage of the Better Pharmaceuticals law.
  Despite our progress, we have further to go. That's why we passed the 
Best Pharmaceuticals conference report today. Senator Dodd and I and 
the other cosponsors knew that the Better Pharmaceuticals bill, could 
be improved. We knew that it had some holes in it. We set out to fill 
those gaps and address the outstanding issues, such as the testing of 
off-patent drugs, which the original law was never designed to include.
  In the conference report we passed today, we have built upon the 
existing law's basic incentive structure to further ensure that we will 
help improve the medication labeling process. Since our law has not 
been implemented for very long, many labels are still in the process of 
being requested and negotiated by the FDA. In our legislation, the new 
timeframes established for labeling negotiations, together with the 
enforcement authority under the existing misbranding statute, will help 
ensure that essential pediatric information generated from studies 
implemented under this law, will result in necessary and timely 
labeling changes. tested for children.
  Our legislation creates a mechanism to ``capture'' the off-patent 
drugs for which the Secretary determines additional studies are needed 
to assess the safety and effectiveness of the drug's use in the 
pediatric population. In other words, our bill provides for the testing 
of some cases of these off-patent drugs.
  By expanding the mission of the existing NIH Foundation to include 
collecting and awarding grants for conducting certain pediatric 
studies, we have provided a funding mechanism for ensuring studies that 
are completed for both off-patent drugs and those marketed on-patent 
drugs that a company declines to study--and for which the Secretary 
determines there is a continuing need for information relating to the 
use of the drug in the pediatric population.
  By first seeking funding through the Foundation, we provide a 
mechanism for drug companies to contribute to the funding of mainly 
off-patent drugs and also to a narrow group of on-patent drugs, 
including those for neonates, for which companies have declined to 
accept the written request to pursue the six month market exclusivity 
extension.
  Finally, to further ensure that the safety of children in clinical 
trials is protected, our legislation requires that the Institute of 
Medicine, IOM, conduct a review of Federal regulations, reports, and 
research involving children and provide recommendations on best 
practices relating to research Senator Dodd and I included as part of 
the Children's Health Act last year.
  In conclusion, I again thank Senator Dodd for his efforts, along with 
Senators Frist, Kennedy, Bond, Collins, and Clinton. Their support and 
dedication to children is what is behind this legislation. Because of 
them, we are sending this conference report to the President for his 
signature. I thank them for their work and their commitment to 
children.
  Mr. REID. Madam President, I ask unanimous consent that the bill be 
read three times, passed, the motion to reconsider be laid upon the 
table, and any statements relating thereto be printed in the Record, 
with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 1789) was read the third time and passed, as follows:

                                S. 1789

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

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

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

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

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

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

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

       ``(a) List of Drugs for Which Pediatric Studies Are 
     Needed.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary, acting through the 
     Director of the National Institutes of Health and in 
     consultation with the Commissioner of Food and Drugs and 
     experts in pediatric research, shall develop, prioritize, and 
     publish an annual list of approved drugs for which--
       ``(A)(i) there is an approved application under section 
     505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(j));
       ``(ii) there is a submitted application that could be 
     approved under the criteria of section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j));
       ``(iii) there is no patent protection or market exclusivity 
     protection under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.); or
       ``(iv) there is a referral for inclusion on the list under 
     section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355a(d)(4)(C)); and
       ``(B) in the case of a drug referred to in clause (i), 
     (ii), or (iii) of subparagraph (A), additional studies are 
     needed to assess the safety and effectiveness of the use of 
     the drug in the pediatric population.
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary shall consider, for each drug on the list--
       ``(A) the availability of information concerning the safe 
     and effective use of the drug in the pediatric population;
       ``(B) whether additional information is needed;
       ``(C) whether new pediatric studies concerning the drug may 
     produce health benefits in the pediatric population; and
       ``(D) whether reformulation of the drug is necessary.
       ``(b) Contracts for Pediatric Studies.--The Secretary shall 
     award contracts to entities that have the expertise to 
     conduct pediatric clinical trials (including qualified 
     universities, hospitals, laboratories, contract research 
     organizations, federally funded programs such as pediatric 
     pharmacology research units, other public or private 
     institutions, or individuals) to enable the entities to 
     conduct pediatric studies concerning one or more drugs 
     identified in the list described in subsection (a).
       ``(c) Process for Contracts and Labeling Changes.--
       ``(1) Written request to holders of approved applications 
     for drugs lacking exclusivity.--The Commissioner of Food and 
     Drugs, in consultation with the Director of the National 
     Institutes of Health, may issue a written request (which 
     shall include a timeframe for negotiations for an agreement) 
     for pediatric studies concerning a drug identified in the 
     list described in subsection (a)(1)(A) (except clause (iv)) 
     to all holders of an approved application for the drug under 
     section 505 of the Federal Food, Drug, and Cosmetic Act. Such 
     a written request shall be made in a manner equivalent to the 
     manner in which a written request is made under subsection 
     (a) or (b) of section 505A of the Federal Food, Drug, and 
     Cosmetic Act, including with respect to information provided 
     on the pediatric studies to be conducted pursuant to the 
     request.
       ``(2) Requests for contract proposals.--If the Commissioner 
     of Food and Drugs does not receive a response to a written 
     request issued under paragraph (1) within 30 days of the date 
     on which a request was issued, or if a referral described in 
     subsection (a)(1)(A)(iv) is made, the Secretary, acting 
     through the Director of the National Institutes of Health

[[Page 25076]]

     and in consultation with the Commissioner of Food and Drugs, 
     shall publish a request for contract proposals to conduct the 
     pediatric studies described in the written request.
       ``(3) Disqualification.--A holder that receives a first 
     right of refusal shall not be entitled to respond to a 
     request for contract proposals under paragraph (2).
       ``(4) Guidance.--Not later than 270 days after the date of 
     enactment of this section, the Commissioner of Food and Drugs 
     shall promulgate guidance to establish the process for the 
     submission of responses to written requests under paragraph 
     (1).
       ``(5) Contracts.--A contract under this section may be 
     awarded only if a proposal for the contract is submitted to 
     the Secretary in such form and manner, and containing such 
     agreements, assurances, and information as the Secretary 
     determines to be necessary to carry out this section.
       ``(6) Reporting of studies.--
       ``(A) In general.--On completion of a pediatric study in 
     accordance with a contract awarded under this section, a 
     report concerning the study shall be submitted to the 
     Director of the National Institutes of Health and the 
     Commissioner of Food and Drugs. The report shall include all 
     data generated in connection with the study.
       ``(B) Availability of reports.--Each report submitted under 
     subparagraph (A) shall be considered to be in the public 
     domain (subject to section 505A(d)(4)(D) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(D)) and shall be 
     assigned a docket number by the Commissioner of Food and 
     Drugs. An interested person may submit written comments 
     concerning such pediatric studies to the Commissioner of Food 
     and Drugs, and the written comments shall become part of the 
     docket file with respect to each of the drugs.
       ``(C) Action by commissioner.--The Commissioner of Food and 
     Drugs shall take appropriate action in response to the 
     reports submitted under subparagraph (A) in accordance with 
     paragraph (7).
       ``(7) Requests for labeling change.--During the 180-day 
     period after the date on which a report is submitted under 
     paragraph (6)(A), the Commissioner of Food and Drugs shall--
       ``(A) review the report and such other data as are 
     available concerning the safe and effective use in the 
     pediatric population of the drug studied;
       ``(B) negotiate with the holders of approved applications 
     for the drug studied for any labeling changes that the 
     Commissioner of Food and Drugs determines to be appropriate 
     and requests the holders to make; and
       ``(C)(i) place in the public docket file a copy of the 
     report and of any requested labeling changes; and
       ``(ii) publish in the Federal Register a summary of the 
     report and a copy of any requested labeling changes.
       ``(8) Dispute resolution.--
       ``(A) Referral to pediatric advisory subcommittee of the 
     anti-infective drugs advisory committee.--If, not later than 
     the end of the 180-day period specified in paragraph (7), the 
     holder of an approved application for the drug involved does 
     not agree to any labeling change requested by the 
     Commissioner of Food and Drugs under that paragraph, the 
     Commissioner of Food and Drugs shall refer the request to the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee.
       ``(B) Action by the pediatric advisory subcommittee of the 
     anti-infective drugs advisory committee.--Not later than 90 
     days after receiving a referral under subparagraph (A), the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee shall--
       ``(i) review the available information on the safe and 
     effective use of the drug in the pediatric population, 
     including study reports submitted under this section; and
       ``(ii) make a recommendation to the Commissioner of Food 
     and Drugs as to appropriate labeling changes, if any.
       ``(9) FDA determination.--Not later than 30 days after 
     receiving a recommendation from the Pediatric Advisory 
     Subcommittee of the Anti-Infective Drugs Advisory Committee 
     under paragraph (8)(B)(ii) with respect to a drug, the 
     Commissioner of Food and Drugs shall consider the 
     recommendation and, if appropriate, make a request to the 
     holders of approved applications for the drug to make any 
     labeling change that the Commissioner of Food and Drugs 
     determines to be appropriate.
       ``(10) Failure to agree.--If a holder of an approved 
     application for a drug, within 30 days after receiving a 
     request to make a labeling change under paragraph (9), does 
     not agree to make a requested labeling change, the 
     Commissioner may deem the drug to be misbranded under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
       ``(11) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under the Federal Food, Drug, and Cosmetic 
     Act when a drug lacks appropriate pediatric labeling. Neither 
     course of action (the Pediatric Advisory Subcommittee of the 
     Anti-Infective Drugs Advisory Committee process or an 
     enforcement action referred to in the preceding sentence) 
     shall preclude, delay, or serve as the basis to stay the 
     other course of action.
       ``(12) Recommendation for formulation changes.--If a 
     pediatric study completed under public contract indicates 
     that a formulation change is necessary and the Secretary 
     agrees, the Secretary shall send a nonbinding letter of 
     recommendation regarding that change to each holder of an 
     approved application.
       ``(d) Authorization of Appropriations.--
       ``(1) In general.--There are authorized to be appropriated 
     to carry out this section--
       ``(A) $200,000,000 for fiscal year 2002; and
       ``(B) such sums as are necessary for each of the 5 
     succeeding fiscal years.
       ``(2) Availability.--Any amount appropriated under 
     paragraph (1) shall remain available to carry out this 
     section until expended.''.

     SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS 
                   FOR DRUGS THAT HAVE MARKET EXCLUSIVITY.

       Section 505A(d) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a(d)) is amended by adding at the end the 
     following:
       ``(4) Written request to holders of approved applications 
     for drugs that have market exclusivity.--
       ``(A) Request and response.--If the Secretary makes a 
     written request for pediatric studies (including neonates, as 
     appropriate) under subsection (c) to the holder of an 
     application approved under section 505(b)(1), the holder, not 
     later than 180 days after receiving the written request, 
     shall respond to the Secretary as to the intention of the 
     holder to act on the request by--
       ``(i) indicating when the pediatric studies will be 
     initiated, if the holder agrees to the request; or
       ``(ii) indicating that the holder does not agree to the 
     request.
       ``(B) No agreement to request.--
       ``(i) Referral.--If the holder does not agree to a written 
     request within the time period specified in subparagraph (A), 
     and if the Secretary determines that there is a continuing 
     need for information relating to the use of the drug in the 
     pediatric population (including neonates, as appropriate), 
     the Secretary shall refer the drug to the Foundation for the 
     National Institutes of Health established under section 499 
     of the Public Health Service Act (42 U.S.C. 290b) (referred 
     to in this paragraph as the `Foundation') for the conduct of 
     the pediatric studies described in the written request.
       ``(ii) Public notice.--The Secretary shall give public 
     notice of the name of the drug, the name of the manufacturer, 
     and the indications to be studied made in a referral under 
     clause (i).
       ``(C) Lack of funds.--On referral of a drug under 
     subparagraph (B)(i), the Foundation shall issue a proposal to 
     award a grant to conduct the requested studies unless the 
     Foundation certifies to the Secretary, within a timeframe 
     that the Secretary determines is appropriate through 
     guidance, that the Foundation does not have funds available 
     under section 499(j)(9)(B)(i) to conduct the requested 
     studies. If the Foundation so certifies, the Secretary shall 
     refer the drug for inclusion on the list established under 
     section 409I of the Public Health Service Act for the conduct 
     of the studies.
       ``(D) Effect of subsection.--Nothing in this subsection 
     (including with respect to referrals from the Secretary to 
     the Foundation) alters or amends section 301(j) of this Act 
     or section 552 of title 5 or section 1905 of title 18, United 
     States Code.
       ``(E) No requirement to refer.--Nothing in this subsection 
     shall be construed to require that every declined written 
     request shall be referred to the Foundation.
       ``(F) Written requests under subsection (b).--For drugs 
     under subsection (b) for which written requests have not been 
     accepted, if the Secretary determines that there is a 
     continuing need for information relating to the use of the 
     drug in the pediatric population (including neonates, as 
     appropriate), the Secretary shall issue a written request 
     under subsection (c) after the date of approval of the 
     drug.''.

     SEC. 5. TIMELY LABELING CHANGES FOR DRUGS GRANTED 
                   EXCLUSIVITY; DRUG FEES.

       (a) Elimination of User Fee Waiver for Pediatric 
     Supplements.--Section 736(a)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(a)(1)) is amended--
       (1) by striking subparagraph (F); and
       (2) by redesignating subparagraph (G) as subparagraph (F).
       (b) Labeling Changes.--
       (1) Definition of priority supplement.--Section 201 of the 
     Federal Food Drug, and Cosmetic Act (21 U.S.C. 321) is 
     amended by adding at the end the following:
       ``(kk) Priority supplement.--The term `priority supplement' 
     means a drug application referred to in section 101(4) of the 
     Food and Drug Administration Modernization Act of 1997 (111 
     Stat. 2298).''.
       (2) Treatment as priority supplements.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended by adding at the end the following:
       ``(l) Labeling Supplements.--
       ``(1) Priority status for pediatric supplements.--Any 
     supplement to an application under section 505 proposing a 
     labeling change pursuant to a report on a pediatric study 
     under this section--
       ``(A) shall be considered to be a priority supplement; and

[[Page 25077]]

       ``(B) shall be subject to the performance goals established 
     by the Commissioner for priority drugs.
       ``(2) Dispute resolution.--
       ``(A) Request for labeling change and failure to agree.--If 
     the Commissioner determines that an application with respect 
     to which a pediatric study is conducted under this section is 
     approvable and that the only open issue for final action on 
     the application is the reaching of an agreement between the 
     sponsor of the application and the Commissioner on 
     appropriate changes to the labeling for the drug that is the 
     subject of the application, not later than 180 days after the 
     date of submission of the application--
       ``(i) the Commissioner shall request that the sponsor of 
     the application make any labeling change that the 
     Commissioner determines to be appropriate; and
       ``(ii) if the sponsor of the application does not agree to 
     make a labeling change requested by the Commissioner, the 
     Commissioner shall refer the matter to the Pediatric Advisory 
     Subcommittee of the Anti-Infective Drugs Advisory Committee.
       ``(B) Action by the pediatric advisory subcommittee of the 
     anti-infective drugs advisory committee.--Not later than 90 
     days after receiving a referral under subparagraph (A)(ii), 
     the Pediatric Advisory Subcommittee of the Anti-Infective 
     Drugs Advisory Committee shall--
       ``(i) review the pediatric study reports; and
       ``(ii) make a recommendation to the Commissioner concerning 
     appropriate labeling changes, if any.
       ``(C) Consideration of recommendations.--The Commissioner 
     shall consider the recommendations of the Pediatric Advisory 
     Subcommittee of the Anti-Infective Drugs Advisory Committee 
     and, if appropriate, not later than 30 days after receiving 
     the recommendation, make a request to the sponsor of the 
     application to make any labeling change that the Commissioner 
     determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application, 
     within 30 days after receiving a request under subparagraph 
     (C), does not agree to make a labeling change requested by 
     the Commissioner, the Commissioner may deem the drug that is 
     the subject of the application to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee process or an enforcement action referred 
     to in the preceding sentence) shall preclude, delay, or serve 
     as the basis to stay the other course of action.''.

     SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

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

     SEC. 7. NEONATES.

       Section 505A(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a(g)) is amended by inserting ``(including 
     neonates in appropriate cases)'' after ``pediatric age 
     groups''.

     SEC. 8. SUNSET.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) is amended by striking subsection (j) and 
     inserting the following:
       ``(j) Sunset.--A drug may not receive any 6-month period 
     under subsection (a) or (c) unless--
       ``(1) on or before October 1, 2007, the Secretary makes a 
     written request for pediatric studies of the drug;
       ``(2) on or before October 1, 2007, an application for the 
     drug is accepted for filing under section 505(b); and
       ``(3) all requirements of this section are met.''.

     SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) (as amended by section 5(b)(2)) is amended 
     by adding at the end the following:
       ``(m) Dissemination of Pediatric Information.--
       ``(1) In general.--Not later than 180 days after the date 
     of submission of a report on a pediatric study under this 
     section, the Commissioner shall make available to the public 
     a summary of the medical and clinical pharmacology reviews of 
     pediatric studies conducted for the supplement, including by 
     publication in the Federal Register.
       ``(2) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.''.

     SEC. 10. CLARIFICATION OF INTERACTION OF PEDIATRIC 
                   EXCLUSIVITY UNDER SECTION 505A OF THE FEDERAL 
                   FOOD, DRUG, AND COSMETIC ACT AND 180-DAY 
                   EXCLUSIVITY AWARDED TO AN APPLICANT FOR 
                   APPROVAL OF A DRUG UNDER SECTION 505(J) OF THAT 
                   ACT.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) (as amended by section 9) is amended by 
     adding at the end the following:
       ``(n) Clarification of Interaction of Market Exclusivity 
     Under This Section and Market Exclusivity Awarded to an 
     Applicant for Approval of a Drug Under Section 505(j).--If a 
     180-day period under section 505(j)(5)(B)(iv) overlaps with a 
     6-month exclusivity period under this section, so that the 
     applicant for approval of a drug under section 505(j) 
     entitled to the 180-day period under that section loses a 
     portion of the 180-day period to which the applicant is 
     entitled for the drug, the 180-day period shall be extended 
     from--
       ``(1) the date on which the 180-day period would have 
     expired by the number of days of the overlap, if the 180-day 
     period would, but for the application of this subsection, 
     expire after the 6-month exclusivity period; or
       ``(2) the date on which the 6-month exclusivity period 
     expires, by the number of days of the overlap if the 180-day 
     period would, but for the application of this subsection, 
     expire during the 6 month exclusivity period.''.

     SEC. 11. PROMPT APPROVAL OF DRUGS UNDER SECTION 505(J) WHEN 
                   PEDIATRIC INFORMATION IS ADDED TO LABELING.

       (a) In General.--Section 505A of the Federal Food, Drug, 
     and Cosmetics Act (21 U.S.C. 355a) (as amended by section 10) 
     is amended by adding at the end the following:
       ``(o) Prompt Approval of Drugs Under Section 505(j) When 
     Pediatric Information Is Added to Labeling.--
       ``(1) General rule.--A drug for which an application has 
     been submitted or approved under section 505(j) shall not be 
     considered ineligible for approval under that section or 
     misbranded under section 502 on the basis that the labeling 
     of the drug omits a pediatric indication or any other aspect 
     of labeling pertaining to pediatric use when the omitted 
     indication or other aspect is protected by patent or by 
     exclusivity under clause (iii) or (iv) of section 
     505(j)(5)(D).
       ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
     section 505(j)(5)(D), the Secretary may require that the 
     labeling of a drug approved under section 505(j) that omits a 
     pediatric indication or other aspect of labeling as described 
     in paragraph (1) include--
       ``(A) a statement that, because of marketing exclusivity 
     for a manufacturer--
       ``(i) the drug is not labeled for pediatric use; or
       ``(ii) in the case of a drug for which there is an 
     additional pediatric use not referred to in paragraph (1), 
     the drug is not labeled for the pediatric use under paragraph 
     (1); and
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, or precautions that the 
     Secretary considers necessary.
       ``(3) Preservation of pediatric exclusivity and other 
     provisions.--This subsection does not affect--
       ``(A) the availability or scope of exclusivity under this 
     section;
       ``(B) the availability or scope of exclusivity under 
     section 505 for pediatric formulations;
       ``(C) the question of the eligibility for approval of any 
     application under section 505(j) that omits any other 
     conditions of approval entitled to exclusivity under clause 
     (iii) or (iv) of section 505(j)(5)(D); or
       ``(D) except as expressly provided in paragraphs (1) and 
     (2), the operation of section 505.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     takes effect on the date of enactment of this Act, including 
     with respect to applications under section 505(j) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that 
     are approved or pending on that date.

     SEC. 12. STUDY CONCERNING RESEARCH INVOLVING CHILDREN.

       (a) Contract With Institute of Medicine.--The Secretary of 
     Health and Human Services shall enter into a contract with 
     the Institute of Medicine for--
       (1) the conduct, in accordance with subsection (b), of a 
     review of--
       (A) Federal regulations in effect on the date of the 
     enactment of this Act relating to research involving 
     children;
       (B) federally prepared or supported reports relating to 
     research involving children; and
       (C) federally supported evidence-based research involving 
     children; and
       (2) the submission to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, not later than 
     2 years after the date of enactment of this Act, of a report 
     concerning the review conducted under paragraph (1)

[[Page 25078]]

     that includes recommendations on best practices relating to 
     research involving children.
       (b) Areas of Review.--In conducting the review under 
     subsection (a)(1), the Institute of Medicine shall consider 
     the following:
       (1) The written and oral process of obtaining and defining 
     ``assent'', ``permission'' and ``informed consent'' with 
     respect to child clinical research participants and the 
     parents, guardians, and the individuals who may serve as the 
     legally authorized representatives of such children (as 
     defined in subpart A of part 46 of title 45, Code of Federal 
     Regulations).
       (2) The expectations and comprehension of child research 
     participants and the parents, guardians, or legally 
     authorized representatives of such children, for the direct 
     benefits and risks of the child's research involvement, 
     particularly in terms of research versus therapeutic 
     treatment.
       (3) The definition of ``minimal risk'' with respect to a 
     healthy child or a child with an illness.
       (4) The appropriateness of the regulations applicable to 
     children of differing ages and maturity levels, including 
     regulations relating to legal status.
       (5) Whether payment (financial or otherwise) may be 
     provided to a child or his or her parent, guardian, or 
     legally authorized representative for the participation of 
     the child in research, and if so, the amount and type of 
     payment that may be made.
       (6) Compliance with the regulations referred to in 
     subsection (a)(1)(A), the monitoring of such compliance 
     (including the role of institutional review boards), and the 
     enforcement actions taken for violations of such regulations.
       (7) The unique roles and responsibilities of institutional 
     review boards in reviewing research involving children, 
     including composition of membership on institutional review 
     boards.
       (c) Requirements of Expertise.--The Institute of Medicine 
     shall conduct the review under subsection (a)(1) and make 
     recommendations under subsection (a)(2) in conjunction with 
     experts in pediatric medicine, pediatric research, and the 
     ethical conduct of research involving children.

     SEC. 13. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

       Section 499 of the Public Health Service Act (42 U.S.C. 
     290b) is amended--
       (1) in subsection (b), by inserting ``(including collection 
     of funds for pediatric pharmacologic research)'' after 
     ``mission'';
       (2) in subsection (c)(1)--
       (A) by redesignating subparagraph (C) as subparagraph (D); 
     and
       (B) by inserting after subparagraph (B) the following:
       ``(C) A program to collect funds for pediatric 
     pharmacologic research and studies listed by the Secretary 
     pursuant to section 409I(a)(1)(A) of this Act and referred 
     under section 505A(d)(4)(C) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355a(d)(4)(C)).'';
       (3) in subsection (d)--
       (A) in paragraph (1)--
       (i) in subparagraph (B)--

       (I) in clause (ii), by striking ``and'' at the end;
       (II) in clause (iii), by striking the period and inserting 
     ``; and''; and
       (III) by adding at the end the following:

       ``(iv) the Commissioner of Food and Drugs.''; and
       (ii) by striking subparagraph (C) and inserting the 
     following:
       ``(C) The ex officio members of the Board under 
     subparagraph (B) shall appoint to the Board individuals from 
     among a list of candidates to be provided by the National 
     Academy of Science. Such appointed members shall include--
       ``(i) representatives of the general biomedical field;
       ``(ii) representatives of experts in pediatric medicine and 
     research;
       ``(iii) representatives of the general biobehavioral field, 
     which may include experts in biomedical ethics; and
       ``(iv) representatives of the general public, which may 
     include representatives of affected industries.''; and
       (B) in paragraph (2), by realigning the margin of 
     subparagraph (B) to align with subparagraph (A);
       (4) in subsection (k)(9)--
       (A) by striking ``The Foundation'' and inserting the 
     following:
       ``(A) In general.--The Foundation''; and
       (B) by adding at the end the following:
       ``(B) Gifts, grants, and other donations.--
       ``(i) In general.--Gifts, grants, and other donations to 
     the Foundation may be designated for pediatric research and 
     studies on drugs, and funds so designated shall be used 
     solely for grants for research and studies under subsection 
     (c)(1)(C).
       ``(ii) Other gifts.--Other gifts, grants, or donations 
     received by the Foundation and not described in clause (i) 
     may also be used to support such pediatric research and 
     studies.
       ``(iii) Report.--The recipient of a grant for research and 
     studies shall agree to provide the Director of the National 
     Institutes of Health and the Commissioner of Food and Drugs, 
     at the conclusion of the research and studies--

       ``(I) a report describing the results of the research and 
     studies; and
       ``(II) all data generated in connection with the research 
     and studies.

       ``(iv) Action by the commissioner of food and drugs.--The 
     Commissioner of Food and Drugs shall take appropriate action 
     in response to a report received under clause (iii) in 
     accordance with paragraphs (7) through (12) of section 
     409I(c), including negotiating with the holders of approved 
     applications for the drugs studied for any labeling changes 
     that the Commissioner determines to be appropriate and 
     requests the holders to make.
       ``(C) Applicability.--Subparagraph (A) does not apply to 
     the program described in subsection (c)(1)(C).'';
       (5) by redesignating subsections (f) through (m) as 
     subsections (e) through (l), respectively;
       (6) in subsection (h)(11) (as so redesignated), by striking 
     ``solicit'' and inserting ``solicit,''; and
       (7) in paragraphs (1) and (2) of subsection (j) (as so 
     redesignated), by striking ``(including those developed under 
     subsection (d)(2)(B)(i)(II))'' each place it appears.

     SEC. 14. PEDIATRIC PHARMACOLOGY ADVISORY COMMITTEE.

       (a) In General.--The Secretary of Health and Human Services 
     shall, under section 222 of the Public Health Service Act (42 
     U.S.C. 217a), convene and consult an advisory committee on 
     pediatric pharmacology (referred to in this section as the 
     ``advisory committee'').
       (b) Purpose.--
       (1) In general.--The advisory committee shall advise and 
     make recommendations to the Secretary, through the 
     Commissioner of Food and Drugs and in consultation with the 
     Director of the National Institutes of Health, on matters 
     relating to pediatric pharmacology.
       (2) Matters included.--The matters referred to in paragraph 
     (1) include--
       (A) pediatric research conducted under sections 351, 409I, 
     and 499 of the Public Health Service Act and sections 501, 
     502, 505, and 505A of the Federal Food, Drug, and Cosmetic 
     Act;
       (B) identification of research priorities related to 
     pediatric pharmacology and the need for additional treatments 
     of specific pediatric diseases or conditions; and
       (C) the ethics, design, and analysis of clinical trials 
     related to pediatric pharmacology.
       (c) Composition.--The advisory committee shall include 
     representatives of pediatric health organizations, pediatric 
     researchers, relevant patient and patient-family 
     organizations, and other experts selected by the Secretary.

     SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS 
                   ADVISORY COMMITTEE.

       (a) Clarification of Authorities.--
       (1) In general.--The Pediatric Subcommittee of the 
     Oncologic Drugs Advisory Committee (referred to in this 
     section as the ``Subcommittee''), in carrying out the mission 
     of reviewing and evaluating the data concerning the safety 
     and effectiveness of marketed and investigational human drug 
     products for use in the treatment of pediatric cancers, 
     shall--
       (A) evaluate and, to the extent practicable, prioritize new 
     and emerging therapeutic alternatives available to treat 
     pediatric cancer;
       (B) provide recommendations and guidance to help ensure 
     that children with cancer have timely access to the most 
     promising new cancer therapies; and
       (C) advise on ways to improve consistency in the 
     availability of new therapeutic agents.
       (2) Membership.--
       (A) In general.--The Secretary shall appoint not more than 
     11 voting members to the Pediatric Subcommittee from the 
     membership of the Pediatric Pharmacology Advisory Committee 
     and the Oncologic Drugs Advisory Committee.
       (B) Request for participation.--The Subcommittee shall 
     request participation of the following members in the 
     scientific and ethical consideration of topics of pediatric 
     cancer, as necessary:
       (i) At least 2 pediatric oncology specialists from the 
     National Cancer Institute.
       (ii) At least 4 pediatric oncology specialists from--

       (I) the Children's Oncology Group;
       (II) other pediatric experts with an established history of 
     conducting clinical trials in children; or
       (III) consortia sponsored by the National Cancer Institute, 
     such as the Pediatric Brain Tumor Consortium, the New 
     Approaches to Neuroblastoma Therapy or other pediatric 
     oncology consortia.

       (iii) At least 2 representatives of the pediatric cancer 
     patient and patient-family community.
       (iv) 1 representative of the nursing community.
       (v) At least 1 statistician.
       (vi) At least 1 representative of the pharmaceutical 
     industry.
       (b) Pre-Clinical Models To Evaluate Promising Pediatric 
     Cancer Therapies.--Section 413 of the Public Health Service 
     Act (42 U.S.C. 285a-2) is amended by adding at the end the 
     following:
       ``(c) Pre-Clinical Models To Evaluate Promising Pediatric 
     Cancer Therapies.--

[[Page 25079]]

       ``(1) Expansion and coordination of activities.--The 
     Director of the National Cancer Institute shall expand, 
     intensify, and coordinate the activities of the Institute 
     with respect to research on the development of preclinical 
     models to evaluate which therapies are likely to be effective 
     for treating pediatric cancer.
       ``(2) Coordination with other institutes.--The Director of 
     the Institute shall coordinate the activities under paragraph 
     (1) with similar activities conducted by other national 
     research institutes and agencies of the National Institutes 
     of Health to the extent that those Institutes and agencies 
     have responsibilities that are related to pediatric 
     cancer.''.
       (c) Clarification of Availability of Investigational New 
     Drugs for Pediatric Study and Use.--
       (1) Amendment of the federal food, drug, and cosmetic 
     act.--Section 505(i)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(i)(1)) is amended--
       (A) in subparagraph (B), by striking ``and'' at the end;
       (B) in subparagraph (C), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following:
       ``(D) the submission to the Secretary by the manufacturer 
     or the sponsor of the investigation of a new drug of a 
     statement of intent regarding whether the manufacturer or 
     sponsor has plans for assessing pediatric safety and 
     efficacy.''.
       (2) Amendment of the public health service act.--Section 
     402(j)(3)(A) of the Public Health Service Act (42 U.S.C. 
     282(j)(3)(A)) is amended in the first sentence--
       (A) by striking ``trial sites, and'' and inserting ``trial 
     sites,''; and
       (B) by striking ``in the trial,'' and inserting ``in the 
     trial, and a description of whether, and through what 
     procedure, the manufacturer or sponsor of the investigation 
     of a new drug will respond to requests for protocol 
     exception, with appropriate safeguards, for single-patient 
     and expanded protocol use of the new drug, particularly in 
     children,''.
       (d) Report.--Not later than January 31, 2003, the Secretary 
     of Health and Human Services, acting through the Commissioner 
     of Food and Drugs and in consultation with the Director of 
     the National Institutes of Health, shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report on patient access to new 
     therapeutic agents for pediatric cancer, including access to 
     single patient use of new therapeutic agents.

     SEC. 16. REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM.

       Not later than October 1, 2006, the Comptroller General of 
     the United States, in consultation with the Secretary of 
     Health and Human Services, shall submit to Congress a report 
     that addresses the following issues, using publicly available 
     data or data otherwise available to the Government that may 
     be used and disclosed under applicable law:
       (1) The effectiveness of section 505A of the Federal Food, 
     Drug, and Cosmetic Act and section 409I of the Public Health 
     Service Act (as added by this Act) in ensuring that medicines 
     used by children are tested and properly labeled, including--
       (A) the number and importance of drugs for children that 
     are being tested as a result of this legislation and the 
     importance for children, health care providers, parents, and 
     others of labeling changes made as a result of such testing;
       (B) the number and importance of drugs for children that 
     are not being tested for their use notwithstanding the 
     provisions of this legislation, and possible reasons for the 
     lack of testing; and
       (C) the number of drugs for which testing is being done, 
     exclusivity granted, and labeling changes required, including 
     the date pediatric exclusivity is granted and the date 
     labeling changes are made and which labeling changes required 
     the use of the dispute resolution process established 
     pursuant to the amendments made by this Act, together with a 
     description of the outcomes of such process, including a 
     description of the disputes and the recommendations of the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee.
       (2) The economic impact of section 505A of the Federal 
     Food, Drug, and Cosmetic Act and section 409I of the Public 
     Health Service Act (as added by this Act), including an 
     estimate of--
       (A) the costs to taxpayers in the form of higher 
     expenditures by medicaid and other Government programs;
       (B) sales for each drug during the 6-month period for which 
     exclusivity is granted, as attributable to such exclusivity;
       (C) costs to consumers and private insurers as a result of 
     any delay in the availability of lower cost generic 
     equivalents of drugs tested and granted exclusivity under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
     and loss of revenue by the generic drug industry and retail 
     pharmacies as a result of any such delay; and
       (D) the benefits to the government, to private insurers, 
     and to consumers resulting from decreased health care costs, 
     including--
       (i) decreased hospitalizations and fewer medical errors, 
     due to more appropriate and more effective use of medications 
     in children as a result of testing and re-labeling because of 
     the amendments made by this Act;
       (ii) direct and indirect benefits associated with fewer 
     physician visits not related to hospitalization;
       (iii) benefits to children from missing less time at school 
     and being less affected by chronic illnesses, thereby 
     allowing a better quality of life;
       (iv) benefits to consumers from lower health insurance 
     premiums due to lower treatment costs and hospitalization 
     rates; and
       (v) benefits to employers from reduced need for employees 
     to care for family members.
       (3) The nature and type of studies in children for each 
     drug granted exclusivity under the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.), including--
       (A) a description of the complexity of the studies;
       (B) the number of study sites necessary to obtain 
     appropriate data;
       (C) the numbers of children involved in any clinical 
     studies; and
       (D) the estimated cost of each of the studies.
       (4) Any recommendations for modifications to the programs 
     established under section 505A of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public 
     Health Service Act (as added by section 3) that the Secretary 
     determines to be appropriate, including a detailed rationale 
     for each recommendation.
       (5) The increased private and Government-funded pediatric 
     research capability associated with this Act and the 
     amendments made by this Act.
       (6) The number of written requests and additional letters 
     of recommendation that the Secretary issues.
       (7) The prioritized list of off-patent drugs for which the 
     Secretary issues written requests.
       (8)(A) The efforts made by Secretary to increase the number 
     of studies conducted in the neonate population; and
       (B) the results of those efforts, including efforts made to 
     encourage the conduct of appropriate studies in neonates by 
     companies with products that have sufficient safety and other 
     information to make the conduct of studies ethical and safe.

     SEC. 17. ADVERSE-EVENT REPORTING.

       (a) Toll-Free Number in Labeling.--Not later than one year 
     after the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall promulgate a final rule 
     requiring that the labeling of each drug for which an 
     application is approved under section 505 of the Federal 
     Food, Drug, and Cosmetic Act (regardless of the date on which 
     approved) include the toll-free number maintained by the 
     Secretary for the purpose of receiving reports of adverse 
     events regarding drugs and a statement that such number is to 
     be used for reporting purposes only, not to receive medical 
     advice. With respect to the final rule:
       (1) The rule shall provide for the implementation of such 
     labeling requirement in a manner that the Secretary considers 
     to be most likely to reach the broadest consumer audience.
       (2) In promulgating the rule, the Secretary shall seek to 
     minimize the cost of the rule on the pharmacy profession.
       (3) The rule shall take effect not later than 60 days after 
     the date on which the rule is promulgated.
       (b) Drugs With Pediatric Market Exclusivity.--
       (1) In general.--During the one-year beginning on the date 
     on which a drug receives a period of market exclusivity under 
     505A of the Federal Food, Drug, and Cosmetic Act, any report 
     of an adverse event regarding the drug that the Secretary of 
     Health and Human Services receives shall be referred to the 
     Office of Pediatric Therapeutics established under section 6 
     of this Act. In considering the report, the Director of such 
     Office shall provide for the review of the report by the 
     Pediatric Advisory Subcommittee of the Anti-Infective Drugs 
     Advisory Committee, including obtaining any recommendations 
     of such Subcommittee regarding whether the Secretary should 
     take action under the Federal Food, Drug, and Cosmetic Act in 
     response to the report.
       (2) Rule of construction.--Paragraph (1) may not be 
     construed as restricting the authority of the Secretary of 
     Health and Human Services to continue carrying out the 
     activities described in such paragraph regarding a drug after 
     the one-year period described in such paragraph regarding the 
     drug has expired.

     SEC. 18. MINORITY CHILDREN AND PEDIATRIC-EXCLUSIVITY PROGRAM.

       (a) Protocols for Pediatric Studies.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended in subsection (d)(2) by inserting after the first 
     sentence the following: ``In reaching an agreement regarding 
     written protocols, the Secretary shall take into account 
     adequate representation of children of ethnic and racial 
     minorities.''.
       (b) Study by General Accounting Office.--

[[Page 25080]]

       (1) In general.--The Comptroller General of the United 
     States shall conduct a study for the purpose of determining 
     the following:
       (A) The extent to which children of ethnic and racial 
     minorities are adequately represented in studies under 
     section 505A of the Federal Food, Drug, and Cosmetic Act; and 
     to the extent ethnic and racial minorities are not adequately 
     represented, the reasons for such under representation and 
     recommendations to increase such representation.
       (B) Whether the Food and Drug Administration has 
     appropriate management systems to monitor the representation 
     of the children of ethnic and racial minorities in such 
     studies.
       (C) Whether drugs used to address diseases that 
     disproportionately affect racial and ethnic minorities are 
     being studied for their safety and effectiveness under 
     section 505A of the Federal Food, Drug, and Cosmetic Act.
       (2) Date certain for completing study.--Not later than 
     January 10, 2003, the Comptroller General shall complete the 
     study required in paragraph (1) and submit to the Congress a 
     report describing the findings of the study.

     SEC. 19. TECHNICAL AND CONFORMING AMENDMENTS.

       Section 505A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355a) (as amended by sections 2(1), 5(b)(2), 9, 
     10, 11, and 17) is amended--
       (1)(A) by striking ``(j)(4)(D)(ii)'' each place it appears 
     and inserting ``(j)(5)(D)(ii)'';
       (B) by striking ``(j)(4)(D)'' each place it appears and 
     inserting ``(j)(5)(D)''; and
       (C) by striking ``505(j)(4)(D)'' each place it appears and 
     inserting ``505(j)(5)(D)'';
       (2) by redesignating subsections (a), (g), (h), (i), (j), 
     (k), (l), (m), (n), and (o) as subsections (b), (a), (g), 
     (h), (n), (m), (i), (j), (k), and (l) respectively;
       (3) by moving the subsections so as to appear in 
     alphabetical order;
       (4) in paragraphs (1), (2), and (3) of subsection (d), 
     subsection (e), and subsection (m) (as redesignated by 
     paragraph (2)), by striking ``subsection (a) or (c)'' and 
     inserting ``subsection (b) or (c)''; and
       (5) in subsection (g) (as redesignated by paragraph (2)), 
     by striking ``subsection (a) or (b)'' and inserting 
     ``subsection (b) or (c)''.

                          ____________________