report was received) are referred to the Office of Pe-
diatric Therapeutics established under section 6 of 
the Best Pharmaceuticals for Children Act (Public 
Law 107–109). In considering the reports, the Di-
rector of such Office shall provide for the review of 
the reports by the Pediatric Advisory Committee, in-
cluding obtaining any recommendations of such 
Committee regarding whether the Secretary should 
take action under this Act in response to such re-
ports. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol-
lowing the one-year period described in paragraph 
(1), the Secretary shall, as appropriate, refer to the 
Office of Pediatric Therapeutics all pediatric adverse 
event reports for a drug for which a pediatric study 
was conducted under this section. In considering 
such reports, the Director of such Office may pro-
vide for the review of such reports by the Pediatric 
Advisory Committee, including obtaining any rec-
ommendation of such Committee regarding whether 
the Secretary should take action in response to such 
reports. 
‘‘(3) EFFECT.—The requirements of this sub-
section shall supplement, not supplant, other review 
of such adverse event reports by the Secretary. 
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‘‘(m) CLARIFICATION OF INTERACTION OF MARKET 
EXCLUSIVITY UNDER THIS SECTION AND MARKET EX-
CLUSIVITY 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 ex-
clusivity 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 ap-
plication 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 six-month exclu-
sivity period. 
‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM-
PLETED.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the enactment of the Improving Pharmaceuticals for 
Children Act of 2007, if pediatric studies have not 
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been completed under subsection (d) and if the Sec-
retary, through the committee established under 
subsection (f), 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— 
‘‘(A) for a drug for which listed patents 
have not expired, make a determination regard-
ing whether an assessment shall be required to 
be submitted under section 505B; or 
‘‘(B) for a drug that has no listed patents 
or has 1 or more listed patents that have ex-
pired, determine whether there are funds avail-
able under section 736 to award a grant to con-
duct the requested studies pursuant to para-
graph (2). 
‘‘(2) FUNDING OF STUDIES.—If, pursuant to 
paragraph (1), the Secretary determines that there 
are funds available under section 736 to award a 
grant to conduct the requested pediatric studies, 
then the Secretary shall issue a proposal to award 
a grant to conduct the requested studies. If the Sec-
retary determines that funds are not available under 
section 736, the Secretary shall refer the drug for 
inclusion on the list established under section 409I 
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of the Public Health Services Act or the conduct of 
studies. 
‘‘(3) PUBLIC NOTICE.—The Secretary shall give 
the public notice of— 
‘‘(A) a decision under paragraph (1)(A) 
not to require an assessment under section 
505B and the basis for such decision; 
‘‘(B) the name of any drug, its manufac-
turer, and the indications to be studied pursu-
ant to a grant made under paragraph (2); and 
‘‘(C) any decision under paragraph (2) to 
include a drug on the list established under sec-
tion 409I of the Public Health Services Act. 
‘‘(4) 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 
‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 
505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LA-
BELING.— 
‘‘(1) GENERAL RULE.—A drug for which an ap-
plication has been submitted or approved under sec-
tion 505(j) shall not be considered ineligible for ap-
proval under that section or misbranded under sec-
tion 502 on the basis that the labeling of the drug 
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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)(F). 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of section 505(j)(5)(F), 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 mar-
keting exclusivity for a manufacturer— 
‘‘(i) the drug is not labeled for pedi-
atric use; or 
‘‘(ii) in the case of a drug for which 
there is an additional pediatric use not re-
ferred to in paragraph (1), the drug is not 
labeled for the pediatric use under para-
graph (1); and 
‘‘(B) a statement of any appropriate pedi-
atric 
contraindications, 
warnings, 
or 
pre-
cautions that the Secretary considers necessary. 
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‘‘(3) PRESERVATION
OF
PEDIATRIC
EXCLU-
SIVITY
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 ap-
proval of any application under section 505(j) 
that omits any other conditions of approval en-
titled to exclusivity under clause (iii) or (iv) of 
section 505(j)(5)(F); or 
‘‘(D) except as expressly provided in para-
graphs (1) and (2), the operation of section 
505. 
‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later 
than 3 years after the date of the enactment of the Im-
proving Pharmaceuticals for Children Act of 2007, the 
Secretary shall enter into a contract with the Institute of 
Medicine to conduct a study and report to Congress re-
garding the written requests made and the studies con-
ducted pursuant to this section. The Institute of Medicine 
may devise an appropriate mechanism to review a rep-
resentative sample of requests made and studies conducted 
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pursuant to this section in order to conduct such study. 
Such study shall— 
‘‘(1) review such representative written requests 
issued by the Secretary since 1997 under sub-
sections (b) and (c); 
‘‘(2) review and assess such representative pedi-
atric studies conducted under subsections (b) and (c) 
since 1997 and labeling changes made as a result of 
such studies; 
‘‘(3) review the use of extrapolation for pedi-
atric subpopulations, the use of alternative endpoints 
for pediatric populations, neonatal assessment tools, 
and ethical issues in pediatric clinical trials; and 
‘‘(4) make recommendations regarding appro-
priate incentives for encouraging pediatric studies of 
biologics. 
‘‘(q) SUNSET.—A drug may not receive any 6-month 
period under subsection (b) or (c) unless— 
‘‘(1) on or before October 1, 2012, the Sec-
retary makes a written request for pediatric studies 
of the drug; 
‘‘(2) on or before October 1, 2012, an applica-
tion for the drug is accepted for filing under section 
505(b); and 
‘‘(3) all requirements of this section are met.’’. 
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(2) EFFECTIVE DATE.—The amendment made 
by this subsection shall apply to written requests 
under section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) made after the date 
of the enactment of this Act. 
(b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 
Section 409I of the Public Health Service Act (42 U.S.C. 
284m) is amended to read as follows: 
‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) LIST
OF
PRIORITY
ISSUES
IN
PEDIATRIC 
THERAPEUTICS.— 
‘‘(1) IN GENERAL.—Not later than one year 
after the date of the enactment of the Improving 
Pharmaceuticals for Children Act of 2007, the Sec-
retary, acting through the Director of the National 
Institutes of Health and in consultation with the 
Commissioner of Food and Drugs and experts in pe-
diatric research, shall develop and publish a priority 
list of needs in pediatric therapeutics, including 
drugs or indications that require study. The list 
shall be revised every three years. 
‘‘(2) CONSIDERATION OF AVAILABLE INFORMA-
TION.—In developing and prioritizing the list under 
paragraph (1), the Secretary shall consider— 
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‘‘(A) therapeutic gaps in pediatrics that 
may 
include 
developmental 
pharmacology, 
pharmacogenetic determinants of drug re-
sponse, metabolism of drugs and biologics in 
children, and pediatric clinical trials; 
‘‘(B) particular pediatric diseases, dis-
orders or conditions where more complete 
knowledge and testing of therapeutics, including 
drugs and biologics, may be beneficial in pedi-
atric populations; and 
‘‘(C) the adequacy of necessary infrastruc-
ture to conduct pediatric pharmacological re-
search, including research networks and trained 
pediatric investigators. 
‘‘(b) PEDIATRIC STUDIES
AND RESEARCH.—The 
Secretary, acting through the National Institutes of 
Health, shall award funds to entities that have the exper-
tise to conduct pediatric clinical trials or other research 
(including qualified universities, hospitals, laboratories, 
contract research organizations, practice groups, federally 
funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) 
to enable the entities to conduct the drug studies or other 
research on the issues described in subsection (a). The 
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Secretary may use contracts, grants or other appropriate 
funding mechanisms to award funds under this subsection. 
‘‘(c) PROCESS
FOR PROPOSED PEDIATRIC STUDY 
REQUESTS AND LABELING CHANGES.— 
‘‘(1) SUBMISSION
OF
PROPOSED
PEDIATRIC 
STUDY REQUEST.—The Director of the National In-
stitutes of Health shall, as appropriate, submit pro-
posed pediatric study requests for consideration by 
the Commissioner of the Food and Drugs for pedi-
atric studies of a specific pediatric indication identi-
fied under subsection (a). Such a proposed pediatric 
study request shall be made in a manner equivalent 
to a written request made under subsection (b) or 
(c) of Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a), including with re-
spect to the information provided on the pediatric 
studies to be conducted pursuant to the request. The 
Director of the National Institutes of Health may 
submit a proposed pediatric study request for a drug 
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)); or 
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‘‘(ii) there is a submitted application that 
could be approved under the criteria of such 
section; and 
‘‘(B) there is no patent protection or mar-
ket exclusivity protection for at least one form 
of the drug under the Federal Food, Drug, and 
Cosmetic Act; and 
‘‘(C) additional studies are needed to as-
sess the safety and effectiveness of the use of 
the drug in the pediatric population. 
‘‘(2) WRITTEN REQUEST TO HOLDERS OF AP-
PROVED APPLICATIONS FOR DRUGS LACKING EXCLU-
SIVITY.—The Commissioner of the Food and Drugs, 
in consultation with the Director of the National In-
stitutes of Health, may issue a written request based 
on the proposed pediatric study request for the indi-
cation or indications submitted pursuant to para-
graph (1) (which shall include a timeframe for nego-
tiations for an agreement) for pediatric studies con-
cerning a drug identified under subsection (a) to all 
holders of an approved application for the drug 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355). Such a written re-
quest shall be made in a manner equivalent to the 
manner in which a written request is made under 
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subsection (a) or (b) of section 505A of such Act 
(21 U.S.C. 355a), including with respect to informa-
tion provided on the pediatric studies to be con-
ducted pursuant to the request and using appro-
priate formulations for each age group for which the 
study is requested. 
‘‘(3) REQUESTS FOR PROPOSALS.—If the Com-
missioner of the Food and Drugs does not receive a 
response to a written request issued under para-
graph (2) not later than 30 days after the date on 
which a request was issued, the Secretary, acting 
through the Director of the National Institutes of 
Health and in consultation with the Commissioner of 
the Food and Drugs, shall publish a request for pro-
posals to conduct the pediatric studies described in 
the written request in accordance with subsection 
(b). 
‘‘(4) DISQUALIFICATION.—A holder that re-
ceives a first right of refusal shall not be entitled to 
respond to a request for proposals under paragraph 
(3). 
‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING 
MECHANISMS.—A contract, grant or other funding 
may be awarded under this section only if a proposal 
is submitted to the Secretary in such form and man-
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ner, 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 an award 
under this section, a report concerning the 
study shall be submitted to the Director of the 
National Institutes of Health and the Commis-
sioner of Food and Drugs. The report shall in-
clude all data generated in connection with the 
study, including a written request if issued. 
‘‘(B) AVAILABILITY
OF
REPORTS.—Each 
report submitted under subparagraph (A) shall 
be considered to be in the public domain (sub-
ject 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 writ-
ten 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. 
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‘‘(C) ACTION
BY
COMMISSIONER.—The 
Commissioner of Food and Drugs shall take ap-
propriate action in response to the reports sub-
mitted under subparagraph (A) in accordance 
with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—Dur-
ing the 180-day period after the date on which a re-
port is submitted under paragraph (6)(A), the Com-
missioner of Food and Drugs shall— 
‘‘(A) review the report and such other data 
as are available concerning the safe and effec-
tive use in the pediatric population of the drug 
studied; 
‘‘(B) negotiate with the holders of ap-
proved applications for the drug studied for any 
labeling changes that the Commissioner of Food 
and Drugs determines to be appropriate and re-
quests 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 and 
through a posting on the website of the Food 
and Drug Administration a summary of the re-
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port and a copy of any requested labeling 
changes. 
‘‘(8) DISPUTE RESOLUTION.— 
‘‘(A) REFERRAL TO PEDIATRIC 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 Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY 
COMMITTEE.—Not later than 90 days after re-
ceiving a referral under subparagraph (A), the 
Pediatric 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 ap-
propriate labeling changes, if any. 
‘‘(9) FDA DETERMINATION.—Not later than 30 
days after receiving a recommendation from the Pe-
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diatric 
Advisory 
Committee 
under 
paragraph 
(8)(B)(ii) with respect to a drug, the Commissioner 
of Food and Drugs shall consider the recommenda-
tion and, if appropriate, make a request to the hold-
ers 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 re-
quested labeling change, the Commissioner of Food 
and Drugs 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 Committee process 
or an enforcement action referred to in the pre-
ceding sentence) shall preclude, delay, or serve as 
the basis to stay the other course of action. 
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‘‘(d) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.—Not later than one year after the date of the enact-
ment of the Improving Pharmaceuticals for Children Act 
of 2007, the Secretary, acting through the Director of the 
National Institutes of Health, shall study the feasibility 
of establishing a compilation of information on pediatric 
drug use and report the findings to Congress. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There are authorized to be 
appropriated to carry out this section— 
‘‘(A) $200,000,000 for fiscal year 2008; 
and 
‘‘(B) such sums as are necessary for each 
of the four succeeding fiscal years. 
‘‘(2) AVAILABILITY.—Any amount appropriated 
under paragraph (1) shall remain available to carry 
out this section until expended.’’. 
(c) FEES RELATING TO DRUGS.—Section 735(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379(6)) is amended by adding at the end the following 
new subparagraph: 
‘‘(G) Activities relating to the support of 
studies of drugs on pediatric populations under 
section 505A(n)(1).’’. 
(d) TRAINING OF PEDIATRIC PHARMACOLOGISTS.— 
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(1) INVESTMENT
IN
TOMORROW’S
PEDIATRIC 
RESEARCHERS.—Section 452G(2) of the Public 
Health Service Act (42 U.S.C. 285g–10(2)) is 
amended by inserting before the period at the end 
the following: ‘‘, including pediatric pharmacological 
research’’. 
(2) PEDIATRIC
RESEARCH
LOAN
REPAYMENT 
PROGRAM.—Section 487F(a)(1) of the Public Health 
Service Act (42 U.S.C. 288–6(a)(1)) is amended by 
inserting ‘‘including pediatric pharmacological re-
search,’’ after ‘‘pediatric research,’’. 
(e) FOUNDATION FOR THE NATIONAL INSTITUTES 
OF HEALTH.—Section 499(c)(1)(c) of the Public Health 
Service Act (42 U.S.C. 290b(c)(1)(c)) is amended by 
striking ‘‘and studies listed by the Secretary pursuant to 
section 409I(a)(1)(A) of this Act and referred under sec-
tion 505A(d)(4)(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(a)(d)(4)(c))’’. 
(f) 
CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.—Section 14 of the Best Pharmaceuticals for 
Children Act (42 U.S.C. 284m note) is amended by adding 
at the end the following new subsection: 
‘‘(d) CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.—Notwithstanding section 14 of the Federal Ad-
visory Committee Act (5 U.S.C. App.), the advisory com-
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mittee shall continue to operate during the five-year period 
beginning on the date of the enactment of the Improving 
Pharmaceuticals for Children Act of 2007.’’. 
(g) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 
DRUGS ADVISORY COMMITTEE.—Section 15 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) 
is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in subparagraph (B), by striking 
‘‘and’’ after the semicolon; 
(ii) in subparagraph (c), by striking 
the period at the end and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(D) provide recommendations to the in-
ternal review committee created under section 
505A(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a(f)) regarding the 
implementation of amendments to sections 
505A and 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a and 355c) 
with respect to the treatment of pediatric can-
cers.’’; and 
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(B) by adding at the end the following new 
paragraph: 
‘‘(3) CONTINUATION OF OPERATION OF SUB-
COMMITTEE.—Notwithstanding section 14 of the 
Federal Advisory Committee Act (5 U.S.C. App.), 
the Subcommittee shall continue to operate during 
the five-year period beginning on the date of the en-
actment of the Improving Pharmaceuticals for Chil-
dren Act of 2007.’’; and 
(2) in subsection (d), by striking ‘‘2003’’ and 
inserting ‘‘2009’’. 
(h) EFFECTIVE DATE AND LIMITATION FOR RULE 
RELATING
TO
TOLL-FREE
NUMBER
FOR
ADVERSE 
EVENTS ON LABELING FOR HUMAN DRUG PRODUCTS.— 
(1) IN GENERAL.—Notwithstanding subchapter 
II of chapter 5, and chapter 7, of title 5, United 
States Code (commonly known as the ‘‘Administra-
tive Procedure Act’’) and any other provision of law, 
the proposed rule issued by the Commissioner of 
Food and Drugs entitled ‘‘Toll-Free Number for Re-
porting Adverse Events on Labeling for Human 
Drug Products,’’ 69 Fed. Reg. 21778, (April 22, 
2004) shall take effect on January 1, 2008, unless 
such Commissioner issues the final rule before such 
date. 
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(2) LIMITATION.—The proposed rule that takes 
effect under subsection (a), or the final rule de-
scribed under subsection (a), shall, notwithstanding 
section 17(a) of the Best Pharmaceuticals for Chil-
dren Act (21 U.S.C. 355b(a)), not apply to a drug— 
(A) for which an application is approved 
under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355); 
(B) that is not described under section 
503(b)(1) of such Act (21 U.S.C. 353(b)(1)); 
and 
(C) the packaging of which includes a toll- 
free number through which consumers can re-
port complaints to the manufacturer or dis-
tributor of the drug. 
SEC. 3. REAUTHORIZATION OF PEDIATRIC RESEARCH EQ-
UITY ACT. 
Section 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c) is amended to read as follows: 
‘‘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)— 
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‘‘(A) under section 505 for a new active in-
gredient, 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 ad-
ministration; shall submit with the application 
the assessments described in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments re-
ferred to in paragraph (1) shall contain data, 
gathered using appropriate formulations for 
each age group for which the assessment is re-
quired, that are adequate— 
‘‘(i) to assess the safety and effective-
ness of the drug or the biological product 
for the claimed indications in all relevant 
pediatric subpopulations; and 
‘‘(ii) to support dosing and adminis-
tration for each pediatric subpopulation for 
which the drug or the biological product is 
safe and effective. 
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‘‘(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 one 
age group can be extrapolated to another 
age group. 
‘‘(iii) INFORMATION
ON
EXTRAPO-
LATION.—A brief documentation of the sci-
entific data supporting the conclusion 
under clauses (i) and (ii) shall be included 
in the medical review that is collected as 
part of the application under section 505 
of this Act or section 351 of the Public 
Health Service Act (42 U.S.C. 262). 
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‘‘(3) DEFERRAL.— 
‘‘(A) IN
GENERAL.—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 prod-
uct if— 
‘‘(i) the Secretary finds that— 
‘‘(I) the drug or biological prod-
uct is ready for approval for use in 
adults before pediatric studies are 
complete; 
‘‘(II) pediatric studies should be 
delayed until additional safety or ef-
fectiveness data have been collected; 
or 
‘‘(III) there is another appro-
priate reason for deferral; and 
‘‘(ii) the applicant submits to the Sec-
retary— 
‘‘(I) certification of the grounds 
for deferring the assessments; 
‘‘(II) a description of the planned 
or ongoing studies; 
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‘‘(III) evidence that the studies 
are being conducted or will be con-
ducted with due diligence and at the 
earliest possible time; and 
‘‘(IV) a timeline for the comple-
tion of such studies. 
‘‘(B) ANNUAL REVIEW.— 
‘‘(i) IN
GENERAL.—On an annual 
basis following the approval of a deferral 
under subparagraph (A), the applicant 
shall submit to the Secretary the following 
information: 
‘‘(I) Information detailing the 
progress made in conducting pediatric 
studies. 
‘‘(II) If no progress has been 
made in conducting such studies, evi-
dence and documentation that such 
studies will be conducted with due 
diligence and at the earliest possible 
time. 
‘‘(ii) PUBLIC AVAILABILITY.—The in-
formation submitted through the annual 
review under clause (I) shall promptly be 
made available to the public in an easily 
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accessible manner, including through the 
website of the Food and Drug Administra-
tion. 
‘‘(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 ap-
propriate, of the requirement to submit assess-
ments 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 exam-
ple, the number of patients is so small or 
the patients are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups; or 
‘‘(iii) The drug or biological product— 
‘‘(I) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients; and 
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‘‘(II) is not likely to be used in a 
substantial number of pediatric pa-
tients. 
‘‘(B) PARTIAL WAIVER.—On the initiative 
of the Secretary or at the request of an appli-
cant, the Secretary shall grant a partial waiver, 
as appropriate, of the requirement to submit as-
sessments 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 exam-
ple, 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 sug-
gesting 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 mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients in that 
age group; and 
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‘‘(II) is not likely to be used by 
a substantial number of pediatric pa-
tients in that age group; or 
‘‘(iv) the applicant can demonstrate 
that reasonable attempts to produce a pe-
diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible 
manner, including through posting on the 
website of the Food and Drug Administration. 
‘‘(D) LABELING
REQUIREMENT.—If the 
Secretary grants a full or partial waiver because 
there is evidence that a drug or biological prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
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in the labeling for the drug or biological prod-
uct. 
‘‘(b) MARKETED DRUGS
AND BIOLOGICAL PROD-
UCTS.— 
‘‘(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 advi-
sory committee meeting, the Secretary may (by 
order in the form of a letter) require the sponsor or 
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) 
and the written request, as appropriate, if the Sec-
retary finds that— 
‘‘(A)(i) the drug or biological product is 
used for a substantial number of pediatric pa-
tients for the labeled indications; and 
‘‘(ii) adequate pediatric labeling could con-
fer a benefit on pediatric patients; 
‘‘(B) there is reason to believe that the 
drug or biological product would represent a 
meaningful therapeutic benefit over existing 
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therapies for pediatric patients for 1 or more of 
the claimed indications; or 
‘‘(C) the absence of adequate pediatric la-
beling could pose a risk to pediatric patients. 
‘‘(2) WAIVERS.— 
‘‘(A) FULL WAIVER.—At the request of an 
applicant, the Secretary shall grant a full waiv-
er, as appropriate, of the requirement to submit 
assessments under this subsection if the appli-
cant certifies and the Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, 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 sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric 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 
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applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, 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 sug-
gesting that the drug or biological product 
would be ineffective or unsafe in that age 
group; 
‘‘(iii)(I) the drug or biological prod-
uct— 
‘‘(aa) does not represent a mean-
ingful 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 pa-
tients 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 pe-
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diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible 
manner, including through posting on the 
website of the Food and Drug Administration. 
‘‘(D) LABELING
REQUIREMENT.—If the 
Secretary grants a full or partial waiver because 
there is evidence that a drug or biological prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
in the labeling for the drug or biological prod-
uct. 
‘‘(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 
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(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 
determines that— 
‘‘(1) if approved, the drug or biological product 
could represent an 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 ap-
plicable provisions of subsections (a) and (b)— 
‘‘(1) the drug or biological product that is the 
subject of the assessment or request may be consid-
ered 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 re-
quest shall not be the basis for a proceeding— 
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‘‘(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 investiga-
tional 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) REVIEW OF PEDIATRIC ASSESSMENTS, DEFER-
RALS, AND WAIVERS.— 
‘‘(1) REVIEW.—The Secretary shall create an 
internal committee to review all pediatric assess-
ments issued under this section and all deferral and 
waiver requests made pursuant to this section. Such 
internal committee shall include individuals, each of 
whom is an employee of the Food and Drug Admin-
istration, with expertise in pediatrics, biopharma-
cology, statistics, drugs and drug formulations, legal 
issues, pediatric ethics, the appropriate expertise, 
such as expertise in child and adolescent psychiatry, 
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pertaining to the pediatric product under review, one 
or more experts from the Office of Pediatric Thera-
peutics, and other individuals designated by the Sec-
retary. 
‘‘(2) ACTION BY COMMITTEE.—The committee 
established under paragraph (1) may perform a 
function under this section using appropriate mem-
bers of the committee described in paragraph (1) 
and need not convene all members of the committee 
described in paragraph (1) in order to perform a 
function under this section. 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
AC-
TION.—For each drug or biological product, the 
committee established under this paragraph shall 
document for each function described in paragraph 
(4) which members of the committee participated in 
such function. 
‘‘(4) REVIEW OF REQUESTS FOR PEDIATRIC AS-
SESSMENTS, DEFERRALS
AND
WAIVERS.—All re-
quests for a pediatric assessment issued pursuant to 
this section and all requests for deferrals and waiv-
ers from the requirement to conduct a pediatric as-
sessment under this section shall be reviewed by the 
committee established under paragraph (1). 
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‘‘(5) TRACKING OF ASSESSMENTS AND LABEL-
ING CHANGES.—The Secretary shall track and make 
available to the public in an easily accessible man-
ner, including through post on the website of the 
Food and Drug Administration— 
‘‘(A) the number of assessments conducted 
under this section; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses assessed under this section; 
‘‘(C) the types of assessments conducted 
under this section, including trial design, the 
number of pediatric patients studied, and the 
number of centers and countries involved; 
‘‘(D) the total number of deferrals re-
quested and granted under this section and, if 
granted, the reasons for such deferrals, the 
timeline for completion, and the number com-
pleted and pending by the specified date, as 
outlined in subsection (a)(3); 
‘‘(E) the number of waivers requested and 
granted under this section and, if granted, the 
reasons for the waivers; 
‘‘(F) the number of pediatric formulations 
developed and the number of pediatric formula-
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tions not developed and the reasons any such 
formulation were not developed; 
‘‘(G) the labeling changes made as a result 
of assessments conducted under this section; 
‘‘(H) an annual summary of labeling 
changes made as a result of assessments con-
ducted under this section for distribution pursu-
ant to subsection (h)(2); and 
‘‘(I) an annual summary of information 
submitted pursuant to subsection (a)(3)(B). 
‘‘(6) COMMITTEE.—The committee established 
under paragraph (1) is the committee established 
under section 505A(f)(1). 
‘‘(g) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS.—Any supplement to an application under 
section 505 and section 351 of the Public Health 
Service Act proposing a labeling change as a result 
of any pediatric assessments conducted pursuant to 
this section— 
‘‘(A) shall be considered a priority applica-
tion or supplement; and 
‘‘(B) shall be subject to the performance 
goals established by the Commissioner for pri-
ority drugs. 
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‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If the Commissioner 
determines that a sponsor and the Commis-
sioner have been unable to reach agreement on 
appropriate changes to the labeling for the drug 
that is the subject of the application or supple-
ment, not later than 180 days after the date of 
the submission of the application or supple-
ment— 
‘‘(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 does not agree 
within 30 days after the Commissioner’s 
request to make a labeling change re-
quested by the Commissioner, the Commis-
sioner shall refer the matter to the Pedi-
atric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY 
COMMITTEE.—Not later than 90 days after re-
ceiving a referral under subparagraph (A)(ii), 
the Pediatric Advisory Committee shall— 
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‘‘(i) review the pediatric study reports; 
and 
‘‘(ii) make a recommendation to the 
Commissioner concerning appropriate la-
beling changes, if any. 
‘‘(C) CONSIDERATION
OF
RECOMMENDA-
TIONS.—The Commissioner shall consider the 
recommendations of the Pediatric Advisory 
Committee and, if appropriate, not later than 
30 days after receiving the recommendation, 
make a request to the sponsor of the applica-
tion to make any labeling changes that the 
Commissioner determines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the 
application, within 30 days after receiving a re-
quest under subparagraph (c), does not agree to 
make a labeling change requested by the Com-
missioner, the Commissioner may deem the 
drug that is the subject of the application to be 
misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Noth-
ing 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 
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Pediatric Advisory Committee process or an en-
forcement action referred to in the preceding 
sentence) shall preclude, delay, or serve as the 
basis to stay the other course of action. 
‘‘(3) OTHER LABELING CHANGES.—If the Sec-
retary makes a determination that a pediatric as-
sessment conducted under this section does or does 
not demonstrate that the drug that is the subject of 
such assessment is safe and effective in pediatric 
populations or subpopulations, including whether 
such assessment results are inconclusive, the Sec-
retary shall order the label of such product to in-
clude information about the results of the assess-
ment and a statement of the Secretary’s determina-
tion. 
‘‘(h) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a pediatric assess-
ment under this section, the Secretary shall make 
available to the public in an easily accessible manner 
the medical, statistical, and clinical pharmacology re-
views of such pediatric assessments, and shall post 
such assessments on the website of the Food and 
Drug Administration. 
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‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING LABELING CHANGES.—The Secretary shall 
require that the sponsors of the assessments that re-
sult in labeling changes that are reflected in the an-
nual summary developed pursuant to subsection 
(f)(5)(H) distribute such information to physicians 
and other health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection shall alter or amend Section 301(j) of 
this Act or section 552 of title 5 or section 1905 of 
title 18, United States Code. 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING
IN
YEAR
ONE.—During the 
one-year period beginning on the date a labeling 
change is made pursuant to subsection (g), the Sec-
retary shall ensure that all adverse event reports 
that have been received for such drug (regardless of 
when such report was received) are referred to the 
Office of Pediatric Therapeutics. In considering the 
report, the Director of such Office shall provide for 
the review of the report by the Pediatric Advisory 
Committee, including obtaining any recommenda-
tions of such committee regarding whether the Sec-
retary should take action under this Act in response 
to such report. 
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‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol-
lowing the one-year period described in paragraph 
(1), the Secretary shall, as appropriate, refer to the 
Office of Pediatric Therapeutics all pediatric adverse 
event reports for a drug for which a pediatric study 
was conducted under this section. In considering the 
report, the Director of such Office may provide for 
the review of the report by the Pediatric Advisory 
Committee, including obtaining any recommendation 
of such Committee regarding whether the Secretary 
should take action in response to such report. 
‘‘(3) EFFECT.—The requirements of this sub-
section shall supplement, not supplant, other review 
of such adverse event reports by the Secretary. 
‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section 
provides to the Secretary any authority to require a pedi-
atric 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. 
‘‘(k) ORPHAN DRUGS.—Unless the Secretary re-
quires otherwise by regulation, this section does not apply 
to any drug for an indication for which orphan designation 
has been granted under section 526. 
‘‘(l) INSTITUTE OF MEDICINE STUDY.— 
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‘‘(1) IN GENERAL.—Not later than three years 
after the date of the enactment of the Improving 
Pharmaceuticals for Children Act of 2007, the Sec-
retary shall contract with the Institute of Medicine 
to conduct a study and report to Congress regarding 
the pediatric studies conducted pursuant to this sec-
tion since 1997. 
‘‘(2) CONTENT OF STUDY.—The study under 
paragraph (1) shall review and assess— 
‘‘(A) pediatric studies conducted pursuant 
to this section since 1997 and labeling changes 
made as a result of such studies; and 
‘‘(B) the use of extrapolation for pediatric 
subpopulations, the use of alternative endpoints 
for pediatric populations, neonatal assessment 
tools, the number and type of pediatric adverse 
events, and ethical issues in pediatric clinical 
trials. 
‘‘(3) REPRESENTATIVE SAMPLE.—The Institute 
of Medicine may devise an appropriate mechanism to 
review a representative sample of studies conducted 
pursuant to this section from each review division 
within the Center for Drug Evaluation and Research 
in order to make the requested assessment.’’. 
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SEC. 4. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 
Not later than September 1, 2011, the Comptroller 
General of the United States, in consultation with the Sec-
retary of Health and Human Services, shall submit to 
Congress a report that addresses the effectiveness of sec-
tions 505A and 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) in ensuring that 
medicines used by children are tested and properly labeled. 
Such report shall include— 
(1) the number and importance of drugs and 
biological products for children that are being tested 
as a result of the amendments made by this Act and 
the importance for children, health care providers, 
parents, and others of labeling changes made as a 
result of such testing; 
(2) the number and importance of drugs and 
biological products for children that are not being 
tested for their use notwithstanding the provisions of 
this Act and possible reasons for the lack of testing, 
including whether the number of written requests 
declined by sponsors or holders of drugs subject to 
section 505A(g)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a(g)(2)) has increased 
or decreased as a result of the amendments made by 
this Act; 
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(3) the number of drugs and biological products 
for which testing is being done and labeling changes 
required, including 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, in-
cluding a description of the disputes and the rec-
ommendations of the Pediatric Advisory Committee; 
(4) any recommendations for modifications to 
the programs established under sections 505A and 
505B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) that the Sec-
retary determines to be appropriate, including a de-
tailed rationale for each recommendation; and 
(5)(A) the efforts made by the Secretary to in-
crease 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 stud-
ies in neonates by companies with products that 
have sufficient safety and other information to make 
the conduct of the studies ethical and safe. 
Æ 
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