Secretary may conclude that adult data may be used 
to support a determination of a reasonable assur-
ance of effectiveness in pediatric populations, as ap-
propriate. 
‘‘(2) EXTRAPOLATION
BETWEEN
SUBPOPULA-
TIONS.—A study may not be needed in each pedi-
atric subpopulation if data from one subpopulation 
can be extrapolated to another subpopulation. 
‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of 
this section, the term ‘pediatric subpopulation’ has the 
meaning given the term in section 520(m)(6)(E)(ii).’’. 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EX-
EMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 
amended— 
(1) in paragraph (3), by striking ‘‘No’’ and in-
serting ‘‘Except as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has 
reason to believe that the requirements of para-
graph (6) are no longer met,’’ after ‘‘public 
health’’; and 
(B) by adding at the end the following: ‘‘If 
the person granted an exemption under para-
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graph (2) fails to demonstrate continued com-
pliance with the requirements of this sub-
section, the Secretary may suspend or withdraw 
the exemption from the effectiveness require-
ments of sections 514 and 515 for a humani-
tarian device only after providing notice and an 
opportunity for an informal hearing.’’; and 
(3) by striking paragraph (6) and inserting 
after paragraph (5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect 
to a person granted an exemption under paragraph (2) 
if each of the following conditions apply: 
‘‘(i)(I) The device with respect to which the ex-
emption is granted is intended for the treatment or 
diagnosis of a disease or condition that occurs in pe-
diatric patients or in a pediatric subpopulation, and 
such device is labeled for use in pediatric patients or 
in a pediatric subpopulation in which the disease or 
condition occurs. 
‘‘(II) The device was not previously approved 
under this subsection for the pediatric patients or 
the pediatric subpopulation described in subclause 
(I) prior to the date of enactment of the Pediatric 
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Medical Device Safety and Improvement Act of 
2007. 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year does not 
exceed the annual distribution number specified by 
the Secretary when the Secretary grants such ex-
emption. The annual distribution number shall be 
based on the number of individuals affected by the 
disease or condition that such device is intended to 
treat, diagnose, or cure, and of that number, the 
number of individuals likely to use the device, and 
the number of devices reasonably necessary to treat 
such individuals. In no case shall the annual dis-
tribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(iii) Such person immediately notifies the Sec-
retary if the number of such devices distributed dur-
ing any calendar year exceeds the annual distribu-
tion number referred to in clause (ii). 
‘‘(iv) The request for such exemption is sub-
mitted on or before October 1, 2013. 
‘‘(B) The Secretary may inspect the records relating 
to the number of devices distributed during any calendar 
year of a person granted an exemption under paragraph 
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(2) for which the prohibition in paragraph (3) does not 
apply. 
‘‘(C) A person may petition the Secretary to modify 
the annual distribution number specified by the Secretary 
under subparagraph (A)(ii) with respect to a device if ad-
ditional information on the number of individuals affected 
by the disease or condition arises, and the Secretary may 
modify such number but in no case shall the annual dis-
tribution number exceed the number identified in para-
graph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Sec-
retary determines through an inspection under subpara-
graph (B), that the number of devices distributed during 
any calendar year exceeds the annual distribution number, 
as required under subparagraph (A)(iii), and modified 
under subparagraph (C), if applicable, then the prohibi-
tion in paragraph (3) shall apply with respect to such per-
son for such device for any sales of such device after such 
notification. 
‘‘(E)(i) In this subsection, the term ‘pediatric pa-
tients’ means patients who are 21 years of age or younger 
at the time of the diagnosis or treatment. 
‘‘(ii) In this subsection, the term ‘pediatric sub-
population’ means 1 of the following populations: 
‘‘(I) Neonates. 
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‘‘(II) Infants. 
‘‘(III) Children. 
‘‘(IV) Adolescents. 
‘‘(7) The Secretary shall refer any report of an ad-
verse event regarding a device for which the prohibition 
under paragraph (3) does not apply pursuant to para-
graph (6)(A) that the Secretary receives to the Office of 
Pediatric Therapeutics, established under section 6 of the 
Best Pharmaceuticals for Children Act (Public Law 107– 
109). In considering the report, the Director of the Office 
of Pediatric Therapeutics, in consultation with experts in 
the Center for Devices and Radiological Health, shall pro-
vide for periodic review of the report by the Pediatric Ad-
visory Committee, including obtaining any recommenda-
tions of such committee regarding whether the Secretary 
should take action under this Act in response to the re-
port. 
‘‘(8) In consultation with the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, the Secretary shall provide for an annual review 
by the Pediatric Advisory Committee of all devices de-
scribed in paragraph (6) to ensure that the exemption 
under paragraph (2) remains appropriate for the pediatric 
populations for which it is granted.’’. 
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(b) REPORT.—Not later than January 1, 2012, the 
Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on 
the impact of allowing persons granted an exemption 
under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 
device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend-
ed by subsection (a)), including— 
(1) an assessment of whether such section 
520(m)(6) (as amended by subsection (a)) has in-
creased the availability of pediatric devices for condi-
tions that occur in small numbers of children, in-
cluding any increase or decrease in the number of— 
(A) exemptions granted under such section 
520(m)(2) for pediatric devices; and 
(B) applications approved under section 
515 of such Act (21 U.S.C. 360e) for devices 
intended to treat, diagnose, or cure conditions 
that occur in pediatric patients or for devices 
labeled for use in a pediatric population; 
(2) the conditions or diseases the pediatric de-
vices were intended to treat or diagnose and the esti-
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mated size of the pediatric patient population for 
each condition or disease; 
(3) the costs of the pediatric devices, based on 
a survey of children’s hospitals; 
(4) the extent to which the costs of such devices 
are covered by health insurance; 
(5) the impact, if any, of allowing profit on ac-
cess to such devices for patients; 
(6) the profits made by manufacturers for each 
device that receives an exemption; 
(7) an estimate of the extent of the use of the 
pediatric devices by both adults and pediatric popu-
lations for a condition or disease other than the con-
dition or disease on the label of such devices; 
(8) recommendations of the Comptroller Gen-
eral of the United States regarding the effectiveness 
of such section 520(m)(6) (as amended by sub-
section (a)) and whether any modifications to such 
section 520(m)(6) (as amended by subsection (a)) 
should be made; 
(9) existing obstacles to pediatric device devel-
opment; and 
(10) an evaluation of the demonstration grants 
described in section 305. 
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(c) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs shall issue guidance for institutional review 
committees on how to evaluate requests for approval for 
devices for which a humanitarian device exemption under 
section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) ACCESS TO FUNDING.—The Director of the Na-
tional Institutes of Health shall designate a contact point 
or office at the National Institutes of Health to help 
innovators and physicians access funding for pediatric 
medical device development. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of enactment of this Act, the Commis-
sioner of Food and Drugs, in collaboration with the 
Director of the National Institutes of Health and the 
Director of the Agency for Healthcare Research and 
Quality, 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 plan for expanding pedi-
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atric medical device research and development. In 
developing such plan, the Commissioner of Food and 
Drugs shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical 
devices. 
(2) CONTENTS.—The plan under paragraph (1) 
shall include— 
(A) the current status of federally funded 
pediatric medical device research; 
(B) any gaps in such research, which may 
include a survey of pediatric medical providers 
regarding unmet pediatric medical device needs, 
as needed; and 
(C) a research agenda for improving pedi-
atric medical device development and Food and 
Drug Administration clearance or approval of 
pediatric medical devices, and for evaluating the 
short- and long-term safety and effectiveness of 
pediatric medical devices. 
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDI-
ATRIC DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue 
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a request for proposals for 1 or more grants or con-
tracts to nonprofit consortia for demonstration 
projects to promote pediatric device development. 
(2) DETERMINATION
ON
GRANTS
OR
CON-
TRACTS.—Not later than 180 days after the date the 
Secretary of Health and Human Services issues a 
request for proposals under paragraph (1), the Sec-
retary shall make a determination on the grants or 
contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that de-
sires to receive a grant or contract under this section shall 
submit an application to the Secretary of Health and 
Human Services at such time, in such manner, and con-
taining such information as the Secretary may require. 
(c) USE OF FUNDS.—A nonprofit consortium that re-
ceives a grant or contract under this section shall— 
(1) encourage innovation by connecting quali-
fied individuals with pediatric device ideas with po-
tential manufacturers; 
(2) mentor and manage pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connect innovators and physicians to exist-
ing Federal resources, including resources from the 
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Food and Drug Administration, the National Insti-
tutes of Health, the Small Business Administration, 
the Department of Energy, the Department of Edu-
cation, the National Science Foundation, the De-
partment of Veterans Affairs, the Agency for 
Healthcare Research and Quality, and the National 
Institute of Standards and Technology; 
(4) assess the scientific and medical merit of 
proposed pediatric device projects; 
(5) assess business feasibility and provide busi-
ness advice; 
(6) provide assistance with prototype develop-
ment; and 
(7) provide assistance with postmarket needs, 
including training, logistics, and reporting. 
(d) COORDINATION.— 
(1) NATIONAL INSTITUTES OF HEALTH.—Each 
consortium that receives a grant or contract under 
this section shall— 
(A) coordinate with the National Institutes 
of Health’s pediatric device contact point or of-
fice, designated under section 304; and 
(B) provide to the National Institutes of 
Health any identified pediatric device needs 
that the consortium lacks sufficient capacity to 
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address or those needs in which the consortium 
has been unable to stimulate manufacturer in-
terest. 
(2) FOOD AND DRUG ADMINISTRATION.—Each 
consortium that receives a grant or contract under 
this section shall coordinate with the Commissioner 
of Food and Drugs and device companies to facili-
tate the application for approval or clearance of de-
vices labeled for pediatric use. 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$6,000,000 for each of fiscal years 2008 through 2012. 
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERA-
PEUTICS AND PEDIATRIC ADVISORY COM-
MITTEE. 
(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 
6(b) of the Best Pharmaceuticals for Children Act (21 
U.S.C. 393a(b)) is amended by inserting ‘‘, including in-
creasing pediatric access to medical devices’’ after ‘‘pedi-
atric issues’’. 
(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 
of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended— 
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(1) in subsection (a), by inserting ‘‘(including 
drugs and biological products) and medical devices’’ 
after ‘‘therapeutics’’; and 
(2) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘(in-
cluding drugs and biological products) and med-
ical devices’’ after ‘‘therapeutics’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘and 505B’’ and inserting ‘‘505B, 510(k), 
515, and 520(m)’’; 
(ii) by striking subparagraph (B) and 
inserting the following: 
‘‘(B) identification of research priorities re-
lated to therapeutics (including drugs and bio-
logical products) and medical devices for pedi-
atric populations and the need for additional 
diagnostics and treatments for specific pediatric 
diseases or conditions;’’; and 
(iii) in subparagraph (C), by inserting 
‘‘(including drugs and biological products) 
and medical devices’’ after ‘‘therapeutics’’. 
SEC. 307. POSTMARKET STUDIES. 
Section 522 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360l) is amended— 
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(1) in subsection (a)— 
(A) by inserting ‘‘, or as a condition to ap-
proval of an application (or a supplement to an 
application) or a product development protocol 
under section 515 or as a condition to clearance 
of a premarket notification under section 
510(k), for a pediatric population or pediatric 
subpopulation,’’ after ‘‘The Secretary may by 
order’’; and 
(B) by inserting ‘‘, or that is indicated for 
pediatric populations or subpopulations or is ex-
pected to have significant use in pediatric popu-
lations,’’ after ‘‘health consequences’’; and 
(2) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE AP-
PROVAL.—Each’’ and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) IN GENERAL.—Each’’; 
(B) by striking ‘‘The Secretary, in con-
sultation’’ and inserting ‘‘Except as provided in 
paragraph (2), the Secretary, in consultation’’; 
(C) by striking ‘‘Any determination’’ and 
inserting ‘‘Except as provided in paragraph (2), 
any determination’’; and 
(D) by adding at the end the following: 
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‘‘(2) LONGER
STUDIES
FOR
PEDIATRIC
DE-
VICES.—The Secretary may by order require a pro-
spective surveillance period of more than 36 months 
with respect to a device that is expected to have sig-
nificant use in pediatric populations if such period of 
more than 36 months is necessary in order to assess 
the impact of the device on growth and development, 
or the effects of growth, development, activity level, 
or other factors on the safety or efficacy of the de-
vice. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may 
request review under section 562 of any order or condition 
requiring postmarket surveillance under this section. Dur-
ing the pendency of such review, the device subject to such 
a postmarket surveillance order or condition shall not be 
deemed misbranded under section 502(t) or otherwise in 
violation of such order or condition or a related require-
ment of this Act unless deemed necessary to protect the 
public health.’’. 
TITLE IV—PEDIATRIC 
RESEARCH EQUITY ACT OF 2007 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Research 
Equity Act of 2007’’. 
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100 
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQ-
UITY ACT. 
(a) IN GENERAL.—Section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amend-
ed 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, on 
or after the date of enactment of the Pediatric Re-
search Equity Act of 2007, an application (or sup-
plement to an application)— 
‘‘(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 de-
scribed in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments re-
ferred to in paragraph (1) shall contain data, 
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101 
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. 
‘‘(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 
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102 
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). 
‘‘(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; 
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103 
‘‘(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; 
‘‘(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: 
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104 
‘‘(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 
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— 
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105 
‘‘(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 
‘‘(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-
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106 
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 
‘‘(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 
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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. 
‘‘(b) MARKETED DRUGS
AND BIOLOGICAL PROD-
UCTS.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
enactment of the Pediatric Research Equity Act of 
2007, after providing notice in the form of a letter 
and an opportunity for written response and a meet-
ing, which may include an advisory committee meet-
ing, 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 hold-
er of a license for a biological product under section 
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351 of the Public Health Service Act to submit by 
a specified date the assessments described in sub-
section (a)(2), if the Secretary 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 
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 
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109 
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 
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— 
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110 
‘‘(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-
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 
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111 
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 
(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. 
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112 
‘‘(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— 
‘‘(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. 
‘‘(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 
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113 
‘‘(2) any planned request by the sponsor for 
waiver or deferral of pediatric studies. 
‘‘(f) REVIEW
OF PEDIATRIC PLANS, DEFERRALS, 
AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 
days after the date of enactment of the Pediatric 
Research Equity Act of 2007, the Secretary shall 
utilize an internal committee to provide consultation 
to reviewing divisions on all pediatric plans and as-
sessments prior to approval of an application or sup-
plement for which a pediatric assessment is required 
under this section and all deferral and waiver re-
quests granted pursuant to this section. Such inter-
nal committee shall include employees of the Food 
and Drug Administration, with expertise in pediat-
rics (including representation from the Office of Pe-
diatric Therapeutics), biopharmacology, statistics, 
chemistry, legal issues, pediatric ethics, and the ap-
propriate expertise pertaining to the pediatric prod-
uct under review, and other individuals designated 
by the Secretary. 
‘‘(2) ACTIVITY BY COMMITTEE.—The committee 
referred to in paragraph (1) may operate using ap-
propriate members of such committee and need not 
convene all members of the committee. 
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114 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
AC-
TION.—For each drug or biological product, the 
committee referred to in paragraph (1) shall docu-
ment, for each activity described in paragraph (4), 
which members of the committee participated in 
such activity. 
‘‘(4) REVIEW OF PEDIATRIC PLANS, DEFERRALS 
AND WAIVERS.—Consultation on pediatric plans and 
assessments by the internal committee pursuant to 
this section shall occur prior to approval of an appli-
cation or supplement for which a pediatric assess-
ment is required under this section. The internal 
committee shall review all requests for deferrals and 
waivers from the requirement to submit a pediatric 
assessment granted under this section and shall pro-
vide recommendations as needed to reviewing divi-
sions. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC 
PLANS, DEFERRALS AND WAIVERS.—Within one year 
after enactment of the Pediatric Research Equity 
Act of 2007, the committee shall conduct a retro-
spective review and analysis of a representative sam-
ple of assessments submitted and deferrals and 
waivers approved under this section since enactment 
of the Pediatric Research Equity Act of 2003. Such 
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115 
review shall include an analysis of the quality and 
consistency of pediatric information in pediatric as-
sessments and the appropriateness of waivers and 
deferrals granted. Based on such review, the Sec-
retary shall issue recommendations to the review di-
visions for improvements and initiate guidance to in-
dustry related to the scope of pediatric studies re-
quired under this section. 
‘‘(6) TRACKING OF ASSESSMENTS AND LABEL-
ING CHANGES.—Beginning on the date of enactment 
of the Pediatric Research Equity Act of 2007, the 
Secretary shall track and make available to the pub-
lic in an easily accessible manner, including through 
posting on the website of the Food and Drug Ad-
ministration— 
‘‘(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 
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116 
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-
tions not developed and the reasons any such 
formulation was 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). 
‘‘(7) 
COMMITTEE.—The 
committee 
utilized 
under paragraph (1) shall be the committee estab-
lished under section 505A(f)(1). 
‘‘(g) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS.—Any supplement to an application under 
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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. 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of enactment of the Pediatric Research 
Equity Act of 2007, the Commissioner deter-
mines that a sponsor and the Commissioner 
have been unable to reach agreement on appro-
priate changes to the labeling for the drug that 
is the subject of the application or supplement, 
not later than 180 days after the date of the 
submission of the application or supplement— 
‘‘(i) the Commissioner shall request 
that the sponsor of the application make 
any labeling change that the Commissioner 
determines to be appropriate; and 
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118 
‘‘(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— 
‘‘(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-
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119 
quest 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.—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 
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, on or 
after the date of enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary makes a 
determination that a pediatric assessment 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 sub-
populations, including whether such assessment re-
sults are inconclusive, the Secretary shall order the 
label of such product to include information about 
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120 
the results of the assessment and a statement of the 
Secretary’s determination. 
‘‘(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. 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of enactment of the Pediatric Research Equity 
Act of 2007, the Secretary shall require that the 
sponsors of the assessments that result in labeling 
changes that are reflected in the annual summary 
developed pursuant to subsection (f)(6)(H) dis-
tribute 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. 
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121 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of enactment of the Pediatric Research Eq-
uity Act of 2007, during the one-year period begin-
ning on the date a labeling change is made pursuant 
to subsection (g), the Secretary shall ensure that all 
adverse event reports that have been received for 
such drug (regardless of when such report was re-
ceived) are referred to the Office of Pediatric Thera-
peutics. In considering the report, the Director of 
such Office shall provide for the review of the report 
by the Pediatric Advisory Committee, including ob-
taining any recommendations of such committee re-
garding whether the Secretary should take action 
under this Act in response to such report. 
‘‘(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 
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122 
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.— 
‘‘(1) IN GENERAL.—Not later than three years 
after the date of the enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary shall con-
tract with the Institute of Medicine to conduct a 
study and report to Congress regarding the pediatric 
studies conducted pursuant to this section since 
1997 and labeling changes made as a result of such 
studies. 
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123 
‘‘(2) CONTENT OF STUDY.—The study under 
paragraph (1) shall review and assess the use of ex-
trapolation for pediatric subpopulations, the use of 
alternative endpoints for pediatric populations, neo-
natal assessment tools, the number and type of pedi-
atric 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.’’. 
(b) APPLICABILITY.—The amendment made in sub-
section (a) applies to assessments required under section 
505B on or after the date of enactment of this Act. 
SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE RE-
PORT. 
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 the 
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, 355c) and section 409I of the 
Public Health Service Act (42 U.S.C. 284m) in ensuring 
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124 
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 title and 
title V 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 title and title V 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 title; 
(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 title, together with 
a description of the outcomes of such process, in-
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125 
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. 
TITLE 
V—BEST 
PHARMA-
CEUTICALS 
FOR 
CHILDREN 
ACT OF 2007 
SEC. 501. SHORT TITLE. 
This title may be cited as the ‘‘Best Pharmaceuticals 
for Children Act of 2007’’. 
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126 
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS 
FOR CHILDREN ACT. 
(a) PEDIATRIC STUDIES OF DRUGS.— 
(1) IN GENERAL.—Section 505A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
amended to read as follows: 
‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) DEFINITIONS.—As used in this section, the term 
‘pediatric studies’ or ‘studies’ means at least one clinical 
investigation (that, at the Secretary’s discretion, may in-
clude pharmacokinetic studies) in pediatric age groups (in-
cluding neonates in appropriate cases) in which a drug 
is anticipated to be used, and at the discretion of the Sec-
retary, may include preclinical studies. 
‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), if, prior to approval of an application that 
is submitted under section 505(b)(1), the Secretary 
determines that information relating to the use of a 
new drug in the pediatric population may produce 
health benefits in that population, the Secretary 
makes a written request for pediatric studies (which 
shall include a timeframe for completing such stud-
ies), the applicant agrees to the request, such stud-
ies are completed using appropriate formulations for 
each age group for which the study is requested 
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within any such timeframe, and the reports thereof 
are submitted and accepted in accordance with sub-
section (d)(3), and if the Secretary has determined 
that labeling changes are appropriate, such changes 
are approved within the timeframe requested by the 
Secretary— 
‘‘(A)(i)(I) the period referred to in sub-
section (c)(3)(E)(ii) of section 505, and in sub-
section (j)(5)(F)(ii) of such section, is deemed 
to be five years and six months rather than five 
years, and the references in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 
four years, to forty-eight months, and to seven 
and one-half years are deemed to be four and 
one-half years, fifty-four months, and eight 
years, respectively; or 
‘‘(II) the period referred to in clauses (iii) 
and (iv) of subsection (c)(3)(E) of such section, 
and in clauses (iii) and (iv) of subsection 
(j)(5)(F) of such section, is deemed to be three 
years and six months rather than three years; 
and 
‘‘(ii) if the drug is designated under sec-
tion 526 for a rare disease or condition, the pe-
riod referred to in section 527(a) is deemed to 
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128 
be seven years and six months rather than 
seven years; and 
‘‘(B)(i) if the drug is the subject of— 
‘‘(I) a listed patent for which a certifi-
cation has been submitted under sub-
section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 
section 505 and for which pediatric studies 
were submitted prior to the expiration of 
the patent (including any patent exten-
sions); or 
‘‘(II) a listed patent for which a cer-
tification has been submitted under sub-
sections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 
of section 505, 
the period during which an application may not 
be approved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of 
six months after the date the patent expires (in-
cluding any patent extensions); or 
‘‘(ii) if the drug is the subject of a listed 
patent for which a certification has been sub-
mitted 
under 
subsection 
(b)(2)(A)(iv) 
or 
(j)(2)(A)(vii)(IV) of section 505, and in the pat-
ent infringement litigation resulting from the 
certification the court determines that the pat-
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129 
ent is valid and would be infringed, the period 
during which an application may not be ap-
proved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of 
six months after the date the patent expires (in-
cluding any patent extensions). 
‘‘(2) EXCEPTION.—The Secretary shall not ex-
tend the period referred to in paragraph (1)(A) or 
(1)(B) if the determination is made later than one 
year prior to the expiration of such period. 
‘‘(c) MARKET EXCLUSIVITY
FOR ALREADY-MAR-
KETED DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), if the Secretary determines that informa-
tion relating to the use of an approved drug in the 
pediatric population may produce health benefits in 
that population and makes a written request to the 
holder of an approved application under section 
505(b)(1) for pediatric studies (which shall include 
a timeframe for completing such studies), the holder 
agrees to the request, such studies are completed 
using appropriate formulations for each age group 
for which the study is requested within any such 
timeframe and the reports thereof are submitted and 
accepted in accordance with subsection (d)(3), and if 
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130 
the Secretary determines that labeling changes are 
appropriate and such changes are approved within 
the timeframe requested by the Secretary— 
‘‘(A)(i)(I) the period referred to in sub-
section (c)(3)(E)(ii) of section 505, and in sub-
section (j)(5)(F)(ii) of such section, is deemed 
to be five years and six months rather than five 
years, and the references in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 
four years, to forty-eight months, and to seven 
and one-half years are deemed to be four and 
one-half years, fifty-four months, and eight 
years, respectively; or 
‘‘(II) the period referred to in clauses (iii) 
and (iv) of subsection (c)(3)(D) of such section, 
and in clauses (iii) and (iv) of subsection 
(j)(5)(F) of such section, is deemed to be three 
years and six months rather than three years; 
and 
‘‘(ii) if the drug is designated under sec-
tion 526 for a rare disease or condition, the pe-
riod referred to in section 527(a) is deemed to 
be seven years and six months rather than 
seven years; and 
‘‘(B)(i) if the drug is the subject of— 
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131 
‘‘(I) a listed patent for which a certifi-
cation has been submitted under sub-
section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 
section 505 and for which pediatric studies 
were submitted prior to the expiration of 
the patent (including any patent exten-
sions); or 
‘‘(II) a listed patent for which a cer-
tification has been submitted under sub-
section (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) 
of section 505, 
the period during which an application may not 
be approved under section 505(c)(3) or section 
505(j)(5)(B)(ii) shall be extended by a period of 
six months after the date the patent expires (in-
cluding any patent extensions); or 
‘‘(ii) if the drug is the subject of a listed 
patent for which a certification has been sub-
mitted 
under 
subsection 
(b)(2)(A)(iv) 
or 
(j)(2)(A)(vii)(IV) of section 505, and in the pat-
ent infringement litigation resulting from the 
certification the court determines that the pat-
ent is valid and would be infringed, the period 
during which an application may not be ap-
proved under section 505(c)(3) or section 
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132 
505(j)(5)(B) shall be extended by a period of 
six months after the date the patent expires (in-
cluding any patent extensions) 
‘‘(2) EXCEPTION.—The Secretary shall not ex-
tend the period referred to in paragraph (1)(A) or 
(1)(B) if the determination is made later than one 
year prior to the expiration of such period. 
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 
‘‘(1) REQUEST FOR STUDIES.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after consultation with the sponsor of an appli-
cation for an investigational new drug under 
section 505(i), the sponsor of an application for 
a new drug under section 505(b)(1), or the 
holder of an approved application for a drug 
under section 505(b)(1) issue to the sponsor or 
holder a written request for the conduct of pedi-
atric studies for such drug. In issuing such re-
quest, the Secretary shall take into account 
adequate representation of children of ethnic 
and racial minorities. Such request to conduct 
pediatric studies shall be in writing and shall 
include a timeframe for such studies and a re-
quest to the sponsor or holder to propose pedi-
atric labeling resulting from such studies. 
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133 
‘‘(B) SINGLE WRITTEN REQUEST.—A sin-
gle written request— 
‘‘(i) may relate to more than one use 
of a drug; and 
‘‘(ii) may include uses that are both 
approved and unapproved. 
‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD-
IES.— 
‘‘(A) REQUEST AND RESPONSE.— 
‘‘(i) IN
GENERAL.—If the Secretary 
makes a written request for pediatric stud-
ies (including neonates, as appropriate) 
under subsection (b) or (c), the applicant 
or holder, not later than 180 days after re-
ceiving the written request, shall respond 
to the Secretary as to the intention of the 
applicant or holder to act on the request 
by— 
‘‘(I) indicating when the pediatric 
studies will be initiated, if the appli-
cant or holder agrees to the request; 
or 
‘‘(II) indicating that the appli-
cant or holder does not agree to the 
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134 
request and stating the reasons for 
declining the request. 
‘‘(ii) DISAGREE WITH REQUEST.—If, 
on or after the date of the enactment of 
the Best Pharmaceuticals for Children Act 
of 2007, the applicant or holder does not 
agree to the request on the grounds that it 
is not possible to develop the appropriate 
pediatric formulation, the applicant or 
holder shall submit to the Secretary the 
reasons such pediatric formulation cannot 
be developed. 
‘‘(B) ADVERSE EVENT REPORTS.—An ap-
plicant or holder that, on or after the date of 
the enactment of the Best Pharmaceuticals for 
Children Act of 2007, agrees to the request for 
such studies shall provide the Secretary, at the 
same time as the submission of the reports of 
such studies, with all postmarket adverse event 
reports regarding the drug that is the subject 
of such studies and are available prior to sub-
mission of such reports. 
‘‘(3) MEETING THE STUDIES REQUIREMENT.— 
Not later than 180 days after the submission of the 
reports of the studies, the Secretary shall accept or 
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135 
reject such reports and so notify the sponsor or 
holder. The Secretary’s only responsibility in accept-
ing or rejecting the reports shall be to determine, 
within the 180-day period, whether the studies fairly 
respond to the written request, have been conducted 
in accordance with commonly accepted scientific 
principles and protocols, and have been reported in 
accordance with the requirements of the Secretary 
for filing. 
‘‘(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. 
‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE-
QUIREMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
a notice of any determination, made on or after the 
date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, that the requirements of 
subsection (d) have been met and that submissions 
and approvals under subsection (b)(2) or (j) of sec-
tion 505 for a drug will be subject to the provisions 
of this section. Such notice shall be published not 
later than 30 days after the date of the Secretary’s 
determination regarding market exclusivity and shall 
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136 
include a copy of the written request made under 
subsection (b) or (c). 
‘‘(2) IDENTIFICATION
OF
CERTAIN
DRUGS.— 
The Secretary shall publish a notice identifying any 
drug for which, on or after the date of the enact-
ment of the Best Pharmaceuticals for Children Act 
of 2007, a pediatric formulation was developed, 
studied, and found to be safe and effective in the pe-
diatric population (or specified subpopulation) if the 
pediatric formulation for such drug is not introduced 
onto the market within one year after the date that 
the Secretary publishes the notice described in para-
graph (1). Such notice identifying such drug shall be 
published not later than 30 days after the date of 
the expiration of such one year period. 
‘‘(f) INTERNAL REVIEW
OF WRITTEN REQUESTS 
AND PEDIATRIC STUDIES.— 
‘‘(1) INTERNAL REVIEW.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish an internal review committee to review 
all written requests issued on or after the date 
of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, in accordance with 
paragraph (2). 
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137 
‘‘(B) MEMBERS.—The committee estab-
lished under subparagraph (A) shall include in-
dividuals with expertise in pediatrics, biophar-
macology, statistics, drugs and drug formula-
tions, legal issues, pediatric ethics, the appro-
priate expertise, such as expertise in child and 
adolescent psychiatry, pertaining to the pedi-
atric product under review, one or more experts 
from the Office of Pediatric Therapeutics, and 
other individuals designated by the Secretary. 
‘‘(2) REVIEW
OF
WRITTEN
REQUESTS.—The 
committee established under paragraph (1) shall re-
view all written requests issued pursuant to this sec-
tion prior to being issued. 
‘‘(3) TRACKING PEDIATRIC STUDIES AND LA-
BELING CHANGES.—The Secretary shall track and 
make available to the public, in an easily accessible 
manner, including through posting on the website of 
the Food and Drug Administration— 
‘‘(A) the number of studies conducted 
under this section and under section 409I of 
the Public Health Service Act; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses, including labeled and off- 
labeled indications, studied under such sections; 
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138 
‘‘(C) the types of studies conducted under 
such sections, including trial design, the num-
ber of pediatric patients studied, and the num-
ber of centers and countries involved; 
‘‘(D) the number of pediatric formulations 
developed and the number of pediatric formula-
tions not developed and the reasons such for-
mulations were not developed; 
‘‘(E) the labeling changes made as a result 
of studies conducted under such sections; 
‘‘(F) an annual summary of labeling 
changes made as a result of studies conducted 
under such sections for distribution pursuant to 
subsection (k)(2); and 
‘‘(G) information regarding reports sub-
mitted on or after the date of the enactment of 
the Best Pharmaceuticals for Children Act of 
2007. 
‘‘(4) COMMITTEE.—The committee established 
under paragraph (1) shall be the committee utilized 
under section 505B(f)(1). 
‘‘(g) 
LIMITATIONS.—Notwithstanding 
subsection 
(c)(2), a drug to which the six-month period under sub-
section (b) or (c) has already been applied— 
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139 
‘‘(1) may receive an additional six-month period 
under subsection (c)(1)(A)(i)(II) for a supplemental 
application if all other requirements under this sec-
tion are satisfied; and 
‘‘(2) may not receive any additional such period 
under subsection (c)(1)(A)(ii). 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE-
QUIREMENTS.—Notwithstanding any other provision of 
law, if any pediatric study is required by a provision of 
law (including a regulation) other than this section and 
such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed 
to satisfy the requirement for market exclusivity pursuant 
to this section. 
‘‘(i) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS
AND
SUPPLEMENTS.—Any application or 
supplement to an application under section 505 pro-
posing a labeling change as a result of any pediatric 
study conducted pursuant to this section— 
‘‘(A) shall be considered to be a priority 
application or supplement; and 
‘‘(B) shall be subject to the performance 
goals established by the Commissioner for pri-
ority drugs. 
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140 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Commis-
sioner determines that the sponsor and the 
Commissioner have been unable to reach agree-
ment 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 sub-
mission 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 within 30 days after the 
Commissioner’s request to make a labeling 
change requested by the Commissioner, the 
Commissioner shall refer the matter 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)(ii), 
the Pediatric Advisory Committee shall— 
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141 
‘‘(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 change that the Com-
missioner 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 
Commissioner, 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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142 
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. 
‘‘(j) OTHER LABELING CHANGES.—If, on or after the 
date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary determines that a pe-
diatric study conducted under this section does or does 
not demonstrate that the drug that is the subject of the 
study is safe and effective in pediatric populations or sub-
populations, including whether such study results are in-
conclusive, the Secretary shall order the labeling of such 
product to include information about the results of the 
study and a statement of the Secretary’s determination. 
‘‘(k) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a report on a pedi-
atric study under this section, the Secretary shall 
make available to the public the medical, statistical, 
and clinical pharmacology reviews of pediatric stud-
ies conducted under subsection (b) or (c). 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of the enactment of the Best Pharmaceuticals 
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143 
for Children Act of 2007, the Secretary shall include 
as a requirement of a written request that the spon-
sors of the studies that result in labeling changes 
that are reflected in the annual summary developed 
pursuant to subsection (f)(3)(F) distribute, at least 
annually (or more frequently if the Secretary deter-
mines that it would be beneficial to the public 
health), such information to physicians and other 
health care providers. 
‘‘(3) 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. 
‘‘(l) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, during the one- 
year period beginning on the date a labeling change 
is approved pursuant to subsection (i), the Secretary 
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 Pe-
diatric Therapeutics established under section 6 of 
the Best Pharmaceuticals for Children Act (Public 
Law 107–109). In considering the reports, the Di-
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144 
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. 
‘‘(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 
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145 
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 Best Pharmaceuticals for Chil-
dren Act of 2007, if pediatric studies have not been 
completed under subsection (d) and if the Secretary, 
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 pe-
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146 
diatric population (including neonates, as appro-
priate), 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 
of the Public Health Service Act or the conduct of 
studies. 
‘‘(3) PUBLIC NOTICE.—The Secretary shall give 
the public notice of— 
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