HR 3580 RDS
the report is submitted, exempted from a fee 
pursuant to section 738(a)(2)(B)(v); and 
‘‘(D) the review time for each device de-
scribed in subparagraphs (A), (B), and (C). 
‘‘(b) DETERMINATION
OF PEDIATRIC EFFECTIVE-
NESS BASED ON SIMILAR COURSE OF DISEASE OR CONDI-
TION OR SIMILAR EFFECT OF DEVICE ON ADULTS.— 
‘‘(1) IN GENERAL.—If the course of the disease 
or condition and the effects of the device are suffi-
ciently similar in adults and pediatric patients, the 
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).’’. 
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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-
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 
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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 the enactment of the Pedi-
atric 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 
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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, 2012. 
‘‘(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 
(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 
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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. 
‘‘(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-
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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) The Secretary, acting through the Office of Pe-
diatric Therapeutics and the Center for Devices and Radi-
ological Health, shall provide for an annual review by the 
Pediatric Advisory Committee of all devices described in 
paragraph (6) to ensure that the exemption under para-
graph (2) remains appropriate for the pediatric popu-
lations for which it is granted.’’. 
(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-
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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, which shall include an eval-
uation of the number of pediatric medical devices— 
(A) that have been or are being studied in 
children; and 
(B) that have been submitted to the Food 
and Drug Administration for approval, clear-
ance, or review under such section 520(m) (as 
amended by this Act) and any regulatory ac-
tions taken. 
(c) GUIDANCE.—Not later than 180 days after the 
date of the enactment of this Act, the Commissioner of 
Food and Drugs shall issue guidance for institutional re-
view committees on how to evaluate requests for approval 
for devices for which a humanitarian device exemption 
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under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) CONTACT POINT FOR AVAILABLE FUNDING.— 
Section 402(b) of the Public Health Service Act (42 
U.S.C. 282(b)) is amended— 
(1) in paragraph (21), by striking ‘‘and’’ after 
the semicolon at the end; 
(2) in paragraph (22), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (22) the fol-
lowing: 
‘‘(23) shall designate a contact point or office 
to help innovators and physicians identify sources of 
funding available for pediatric medical device devel-
opment.’’. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, the 
Director of the National Institutes of Health, and 
the Director of the Agency for Healthcare Research 
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and Quality, shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Committee on Energy and Commerce of 
the House of Representatives a plan for expanding 
pediatric medical device research and development. 
In developing such plan, the Secretary of Health and 
Human Services shall consult with individuals and 
organizations 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. 
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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 the enactment of this Act, 
the Secretary of Health and Human Services shall 
issue a request for proposals for 1 or more grants 
or contracts 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 facilitate 
the development, production, and distribution of pediatric 
medical devices by— 
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(1) encouraging innovation and connecting 
qualified individuals with pediatric device ideas with 
potential manufacturers; 
(2) mentoring and managing pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connecting innovators and physicians to ex-
isting Federal and non-Federal resources, including 
resources from the Food and Drug Administration, 
the National Institutes of Health, the Small Busi-
ness Administration, the Department of Energy, the 
Department of Education, the National Science 
Foundation, the Department of Veterans Affairs, 
the Agency for Healthcare Research and Quality, 
and the National Institute of Standards and Tech-
nology; 
(4) assessing the scientific and medical merit of 
proposed pediatric device projects; and 
(5) providing assistance and advice as needed 
on business development, personnel training, proto-
type development, postmarket needs, and other ac-
tivities consistent with the purposes of this section. 
(d) COORDINATION.— 
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(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 402(b)(23) of the 
Public Health Service Act, as added by section 
304(a) of this Act; and 
(B) provide to the National Institutes of 
Health any identified pediatric device needs 
that the consortium lacks sufficient capacity to 
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. 
(3) EFFECTIVENESS
AND
OUTCOMES.—Each 
consortium that receives a grant or contract under 
this section shall annually report to the Secretary of 
Health and Human Services on the status of pedi-
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ing the pendency of such review, the device subject to such 
a postmarket surveillance order or condition shall not, be-
cause of noncompliance with such order or condition, be 
deemed in violation of section 301(q)(1)(C), adulterated 
under section 501(f)(1), misbranded under section 
502(t)(3), or in violation of, as applicable, section 510(k) 
or section 515, 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’’. 
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 the enactment of the Pediatric 
Research Equity Act of 2007, 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 de-
scribed 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 any pertinent reviews for 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 
Web site of the Food and Drug Adminis-
tration. 
‘‘(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 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 Web 
site 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 (that, for a drug approved under 
section 505, references a declined written request 
under section 505A for a labeled indication which 
written request is not referred under section 
505A(n)(1)(A) to the Foundation of the National 
Institutes of Health for the pediatric studies), the 
Secretary may (by order in the form of a letter) re-
quire the sponsor or holder of an approved applica-
tion 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 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 
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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 
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 Web 
site 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. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection alters or amends section 301(j) of this 
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Act or section 552 of title 5 or section 1905 of title 
18, United States Code. 
‘‘(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) 
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. 
‘‘(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 
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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 
‘‘(2) any planned request by the sponsor for 
waiver or deferral of pediatric studies. 
‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, 
DEFERRALS, AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 
days after the date of the enactment of the Pediatric 
Research Equity Act of 2007, the Secretary shall 
utilize the internal committee established under sec-
tion 505C to provide consultation to reviewing divi-
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sions on all pediatric plans and assessments prior to 
approval of an application or supplement for which 
a pediatric assessment is required under this section 
and all deferral and waiver requests granted pursu-
ant to this section. 
‘‘(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. 
‘‘(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) or 
(5), which members of the committee participated in 
such activity. 
‘‘(4) REVIEW
OF
PEDIATRIC
PLANS, ASSESS-
MENTS, DEFERRALS, AND
WAIVERS.—Consultation 
on pediatric plans and assessments by the committee 
referred to in paragraph (1) pursuant to this section 
shall occur prior to approval of an application or 
supplement for which a pediatric assessment is re-
quired under this section. The committee shall re-
view all requests for deferrals and waivers from the 
requirement to submit a pediatric assessment grant-
ed under this section and shall provide recommenda-
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tions as needed to reviewing divisions, including with 
respect to whether such a supplement, when sub-
mitted, shall be considered for priority review. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC 
ASSESSMENTS, 
DEFERRALS, 
AND
WAIVERS.—Not 
later than 1 year after the date of the enactment of 
the Pediatric Research Equity Act of 2007, the com-
mittee referred to in paragraph (1) shall conduct a 
retrospective review and analysis of a representative 
sample of assessments submitted and deferrals and 
waivers approved under this section since the enact-
ment of the Pediatric Research Equity Act of 2003. 
Such review shall include an analysis of the quality 
and consistency of pediatric information in pediatric 
assessments 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.—The Secretary, in consultation with 
the committee referred to in paragraph (1), shall 
track and make available to the public in an easily 
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accessible manner, including through posting on the 
Web site 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-
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; 
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‘‘(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); 
‘‘(I) an annual summary of information 
submitted pursuant to subsection (a)(3)(B); 
and 
‘‘(J) the number of times the committee 
referred to in paragraph (1) made a rec-
ommendation to the Secretary under paragraph 
(4) regarding priority review, the number of 
times the Secretary followed or did not follow 
such a recommendation, and, if not followed, 
the reasons why such a recommendation was 
not followed. 
‘‘(g) LABELING CHANGES.— 
‘‘(1) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of the 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, 
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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 
‘‘(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 
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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 
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 210 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 Web site of the Food and 
Drug Administration. 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of the enactment of the Pediatric Research Eq-
uity Act of 2007, the Secretary shall require that 
the sponsors of the assessments that result in label-
ing changes that are reflected in the annual sum-
mary developed pursuant to subsection (f)(6)(H) dis-
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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. 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of the enactment of the Pediatric Research 
Equity Act of 2007, during the one-year period be-
ginning on the date a labeling change is made pur-
suant to subsection (g), the Secretary shall ensure 
that all adverse event reports that have been re-
ceived for such drug (regardless of when such report 
was received) are referred to the Office of Pediatric 
Therapeutics. In considering such reports, the Direc-
tor of such Office shall provide for the review of 
such reports by the Pediatric Advisory Committee, 
including 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 
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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. 
‘‘(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-
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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 or pre-
cursor regulations since 1997 and labeling changes 
made as a result of such studies. 
‘‘(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. 
‘‘(m) INTEGRATION WITH OTHER PEDIATRIC STUD-
IES.—The authority under this section shall remain in ef-
fect so long as an application subject to this section may 
be accepted for filing by the Secretary on or before the 
date specified in section 505A(q).’’. 
(b) APPLICABILITY.— 
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(1) IN GENERAL.—Notwithstanding subsection 
(h) of section 505B of the Federal Food, Drug and 
Cosmetic Act, as in effect on the day before the date 
of the enactment of this Act, a pending assessment, 
including a deferred assessment, required under 
such section 505B shall be deemed to have been re-
quired under section 505B of the Federal Food, 
Drug and Cosmetic Act as in effect on or after the 
date of the enactment of this Act. 
(2) CERTAIN ASSESSMENTS AND WAIVER RE-
QUESTS.—An assessment pending on or after the 
date that is 1 year prior to the date of the enact-
ment of this Act shall be subject to the tracking and 
disclosure requirements established under such sec-
tion 505B, as in effect on or after such date of en-
actment, except that any such assessments sub-
mitted or waivers of such assessments requested be-
fore such date of enactment shall not be subject to 
subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) 
of such section 505B. 
SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505B the following: 
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‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDI-
ATRIC PLANS, ASSESSMENTS, DEFERRALS, 
AND WAIVERS. 
‘‘The Secretary shall establish an internal committee 
within the Food and Drug Administration to carry out the 
activities as described in sections 505A(f) and 505B(f). 
Such internal committee shall include employees of the 
Food and Drug Administration, with expertise in pediat-
rics (including representation from the Office of Pediatric 
Therapeutics), biopharmacology, statistics, chemistry, 
legal issues, pediatric ethics, and the appropriate expertise 
pertaining to the pediatric product under review, such as 
expertise in child and adolescent psychiatry, and other in-
dividuals designated by the Secretary.’’. 
SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE RE-
PORT. 
Not later than January 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 
that medicines used by children are tested and properly 
labeled. Such report shall include— 
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(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; 
(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-
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-
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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’’. 
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 
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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 
within any such timeframe, and the reports thereof 
are submitted and accepted in accordance with sub-
section (d)(3)— 
‘‘(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 
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(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 
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 
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‘‘(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-
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 made under subsection 
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(d)(3) is made later than 9 months prior to the expi-
ration 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)— 
‘‘(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 
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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— 
‘‘(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, 
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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 
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 made under subsection 
(d)(3) is made later than 9 months prior to the expi-
ration of such period. 
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 
‘‘(1) REQUEST FOR STUDIES.— 
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‘‘(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. 
‘‘(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.— 
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‘‘(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 
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 
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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 
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. 
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‘‘(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 
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 
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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.—The Secretary shall 
utilize the internal review committee established 
under section 505C 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). 
‘‘(2) REVIEW
OF
WRITTEN
REQUESTS.—The 
committee referred to in paragraph (1) shall review 
all written requests issued pursuant to this section 
prior to being issued. 
‘‘(3) REVIEW
OF
PEDIATRIC
STUDIES.—The 
committee referred to in paragraph (1) may review 
studies conducted pursuant to this section to make 
a recommendation to the Secretary whether to ac-
cept or reject such reports under subsection (d)(3). 
‘‘(4) ACTIVITY BY COMMITTEE.—The committee 
referred to in paragraph (1) may operate using ap-
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propriate members of such committee and need not 
convene all members of the committee. 
‘‘(5) DOCUMENTATION
OF
COMMITTEE
AC-
TION.—For each drug, the committee referred to in 
paragraph (1) shall document, for each activity de-
scribed in paragraph (2) or (3), which members of 
the committee participated in such activity. 
‘‘(6) TRACKING PEDIATRIC STUDIES AND LA-
BELING CHANGES.—The Secretary, in consultation 
with the committee referred to in paragraph (1), 
shall track and make available to the public, in an 
easily accessible manner, including through posting 
on the Web site of the Food and Drug Administra-
tion— 
‘‘(A) the number of studies conducted 
under this section and under section 409I of 
the Public Health Service Act; 
‘‘(B) the specific drugs and drug uses, in-
cluding labeled and off-labeled indications, stud-
ied under such sections; 
‘‘(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; 
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‘‘(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. 
‘‘(g) 
LIMITATIONS.—Notwithstanding 
subsection 
(c)(2), a drug to which the six-month period under sub-
section (b) or (c) has already been applied— 
‘‘(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, except that such drug may not re-
ceive any additional such period under subsection 
(c)(1)(B); and 
‘‘(2) may not receive any additional such period 
under subsection (c)(1)(A)(ii). 
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‘‘(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. 
‘‘(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 
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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— 
‘‘(i) review the pediatric study reports; 
and 
‘‘(ii) make a recommendation to the 
Commissioner concerning appropriate la-
beling changes, if any. 
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‘‘(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 
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. 
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‘‘(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, including whether such study 
results are inconclusive, in pediatric populations or sub-
populations, 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 210 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 
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 
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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-
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 
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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 
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 
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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 of a drug have 
not been completed under subsection (d) and if the 
Secretary, through the committee established under 
section 505C, 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 carry out the fol-
lowing: 
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‘‘(A) For a drug for which a listed patent 
has not expired, make a determination regard-
ing whether an assessment shall be required to 
be submitted under section 505B(b). Prior to 
making such a determination, the Secretary 
may not take more than 30 days to certify 
whether the Foundation for the National Insti-
tutes of Health has sufficient funding at the 
time of such certification to initiate and fund 
all of the studies in the written request in their 
entirety within the timeframes specified within 
the written request. Only if the Secretary 
makes such certification in the affirmative, the 
Secretary shall refer all pediatric studies in the 
written request to the Foundation for the Na-
tional Institutes of Health for the conduct of 
such studies, and such Foundation shall fund 
such studies. If no certification has been made 
at the end of the 30-day period, or if the Sec-
retary certifies that funds are not sufficient to 
initiate and fund all the studies in their en-
tirety, the Secretary shall consider whether as-
sessments shall be required under section 
505B(b) for such drug. 
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‘‘(B) For a drug that has no listed patents 
or has 1 or more listed patents that have ex-
pired, the Secretary shall refer the drug for in-
clusion on the list established under section 
409I of the Public Health Service Act for the 
conduct of studies. 
‘‘(2) PUBLIC NOTICE.—The Secretary shall give 
the public notice of a decision under paragraph 
(1)(A) not to require an assessment under section 
505B and the basis for such decision. 
‘‘(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. 
‘‘(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 
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 
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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. 
‘‘(3) PRESERVATION
OF
PEDIATRIC
EXCLU-
SIVITY
AND
OTHER
PROVISIONS.—This subsection 
does not affect— 
‘‘(A) the availability or scope of exclusivity 
under this section; 
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‘‘(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 Best 
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 regarding the 
written requests made and the studies conducted pursuant 
to this section. The Institute of Medicine may devise an 
appropriate mechanism to review a representative sample 
of requests made and studies conducted 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) 
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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; 
‘‘(4) review and assess the pediatric studies of 
biological products as required under subsections (a) 
and (b) of section 505B; and 
‘‘(5) 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.’’. 
(2) APPLICABILITY.— 
(A) IN GENERAL.—The amendment made 
by this subsection shall apply to written re-
quests under section 505A of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 355a) 
issued on or after the date of the enactment of 
this Act. 
(B) CERTAIN
WRITTEN
REQUESTS.—A 
written request issued under section 505A of 
the Federal Food, Drug, and Cosmetic Act, as 
in effect on the day before the date of the en-
actment of this Act, which has been accepted 
and for which no determination under sub-
section (d)(2) of such section has been made 
before such date of enactment, shall be subject 
to such section 505A, except that such written 
requests 
shall 
be 
subject 
to 
subsections 
(d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), 
(k)(1), (l)(1), and (n) of section 505A of the 
Federal Food, Drug, and Cosmetic Act, as in 
effect on or 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.— 
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‘‘(1) IN GENERAL.—Not later than one year 
after the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Secretary, 
acting through the Director of the National Insti-
tutes of Health and in consultation with the Com-
missioner of Food and Drugs and experts in pedi-
atric 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— 
‘‘(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-
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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 
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 Food and Drugs for pediatric 
studies of a specific pediatric indication identified 
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 
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(c) of section 505A of the Federal Food, Drug, and 
Cosmetic Act, including with respect to the informa-
tion provided on the pediatric studies to be con-
ducted pursuant to the request. The Director of the 
National Institutes of Health may submit a pro-
posed 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; or 
‘‘(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 Food and Drugs, in 
consultation with the Director of the National Insti-
tutes of Health, may issue a written request based 
on the proposed pediatric study request for the indi-
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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. Such a written request shall be made 
in a manner equivalent to the manner in which a 
written request is made under subsection (b) or (c) 
of section 505A of such Act, including with respect 
to information provided on the pediatric studies to 
be conducted pursuant to the request and using ap-
propriate formulations for each age group for which 
the study is requested. 
‘‘(3) REQUESTS FOR PROPOSALS.—If the Com-
missioner of Food and Drugs does not receive a re-
sponse to a written request issued under paragraph 
(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 Food and 
Drugs, shall publish a request for proposals to con-
duct the pediatric studies described in the written 
request in accordance with subsection (b). 
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‘‘(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-
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) of the Federal Food, 
Drug, and Cosmetic Act) and shall be assigned 
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a docket number by the Commissioner of Food 
and Drugs. An interested person may submit 
written comments concerning such pediatric 
studies to the Commissioner of Food and 
Drugs, and the written comments shall become 
part of the docket file with respect to each of 
the drugs. 
‘‘(C) ACTION
BY
COMMISSIONER.—The 
Commissioner of Food and Drugs shall take 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 
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‘‘(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 Web site of the Food 
and Drug Administration a summary of the re-
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 
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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-
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. 
‘‘(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 
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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. 
‘‘(d) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.—Not later than one year after the date of the enact-
ment of the Best 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) 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 
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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)’ ’’ and inserting 
‘‘and studies for which the Secretary issues a certification 
in the affirmative under section 505A(n)(1)(A) of the Fed-
eral Food, Drug, and Cosmetic Act’’. 
(d) 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, the advisory committee shall con-
tinue to operate during the five-year period beginning on 
the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007.’’. 
(e) 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; 
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(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 
505B(f) of the Federal Food, Drug, and Cos-
metic Act regarding the implementation of 
amendments to sections 505A and 505B of the 
Federal Food, Drug, and Cosmetic Act with re-
spect to the treatment of pediatric cancers.’’; 
and 
(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, the Subcommittee 
shall continue to operate during the five-year period 
beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007.’’; and 
(2) in subsection (d), by striking ‘‘2003’’ and 
inserting ‘‘2009’’. 
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(f) 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. 
(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 
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(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. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 
(a) INVESTMENT IN TOMORROW’S PEDIATRIC RE-
SEARCHERS.—Section 452G(2) of the Public Health Serv-
ice Act (42 U.S.C. 285g–10(2)) is amended by adding be-
fore the period at the end the following: ‘‘, including pedi-
atric pharmacological research’’. 
(b) PEDIATRIC RESEARCH LOAN REPAYMENT PRO-
GRAM.—Section 487F(a)(1) of the Public Health Service 
Act (42 U.S.C. 288–6(a)(1)) is amended by inserting ‘‘in-
cluding pediatric pharmacological research,’’ after ‘‘pedi-
atric research,’’. 
TITLE VI—REAGAN-UDALL 
FOUNDATION 
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE 
FOOD AND DRUG ADMINISTRATION. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend-
ed by adding at the end the following: 
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‘‘Subchapter I—Reagan-Udall Foundation for 
the Food and Drug Administration 
‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUN-
DATION. 
‘‘(a) IN GENERAL.—A nonprofit corporation to be 
known as the Reagan-Udall Foundation for the Food and 
Drug Administration (referred to in this subchapter as the 
‘Foundation’) shall be established in accordance with this 
section. The Foundation shall be headed by an Executive 
Director, appointed by the members of the Board of Direc-
tors under subsection (e). The Foundation shall not be 
an agency or instrumentality of the United States Govern-
ment. 
‘‘(b) PURPOSE OF FOUNDATION.—The purpose of 
the Foundation is to advance the mission of the Food and 
Drug Administration to modernize medical, veterinary, 
food, food ingredient, and cosmetic product development, 
accelerate innovation, and enhance product safety. 
‘‘(c) DUTIES OF THE FOUNDATION.—The Founda-
tion shall— 
‘‘(1) taking into consideration the Critical Path 
reports and priorities published by the Food and 
Drug Administration, identify unmet needs in the 
development, manufacture, and evaluation of the 
safety and effectiveness, including postapproval, of 
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devices, including diagnostics, biologics, and drugs, 
and the safety of food, food ingredients, and cos-
metics, and including the incorporation of more sen-
sitive and predictive tools and devices to measure 
safety; 
‘‘(2) establish goals and priorities in order to 
meet the unmet needs identified in paragraph (1); 
‘‘(3) in consultation with the Secretary, identify 
existing and proposed Federal intramural and extra-
mural research and development programs relating 
to the goals and priorities established under para-
graph (2), coordinate Foundation activities with 
such programs, and minimize Foundation duplica-
tion of existing efforts; 
‘‘(4) award grants to, or enter into contracts, 
memoranda of understanding, or cooperative agree-
ments with, scientists and entities, which may in-
clude the Food and Drug Administration, university 
consortia, public-private partnerships, institutions of 
higher education, entities described in section 
501(c)(3) of the Internal Revenue Code (and exempt 
from tax under section 501(a) of such Code), and 
industry, to efficiently and effectively advance the 
goals and priorities established under paragraph (2); 
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‘‘(5) recruit meeting participants and hold or 
sponsor (in whole or in part) meetings as appro-
priate to further the goals and priorities established 
under paragraph (2); 
‘‘(6) release and publish information and data 
and, to the extent practicable, license, distribute, 
and release material, reagents, and techniques to 
maximize, promote, and coordinate the availability of 
such material, reagents, and techniques for use by 
the Food and Drug Administration, nonprofit orga-
nizations, and academic and industrial researchers 
to further the goals and priorities established under 
paragraph (2); 
‘‘(7) ensure that— 
‘‘(A) action is taken as necessary to obtain 
patents for inventions developed by the Founda-
tion or with funds from the Foundation; 
‘‘(B) action is taken as necessary to enable 
the licensing of inventions developed by the 
Foundation or with funds from the Foundation; 
and 
‘‘(C) executed licenses, memoranda of un-
derstanding, material transfer agreements, con-
tracts, and other such instruments, promote, to 
the maximum extent practicable, the broadest 
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conversion to commercial and noncommercial 
applications of licensed and patented inventions 
of the Foundation to further the goals and pri-
orities established under paragraph (2); 
‘‘(8) provide objective clinical and scientific in-
formation to the Food and Drug Administration 
and, upon request, to other Federal agencies to as-
sist in agency determinations of how to ensure that 
regulatory policy accommodates scientific advances 
and meets the agency’s public health mission; 
‘‘(9) conduct annual assessments of the unmet 
needs identified in paragraph (1); and 
‘‘(10) carry out such other activities consistent 
with the purposes of the Foundation as the Board 
determines appropriate. 
‘‘(d) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—The Foundation shall 
have a Board of Directors (referred to in this 
subchapter as the ‘Board’), which shall be com-
posed of ex officio and appointed members in 
accordance with this subsection. All appointed 
members of the Board shall be voting members. 
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‘‘(B) EX OFFICIO MEMBERS.—The ex offi-
cio members of the Board shall be the following 
individuals or their designees: 
‘‘(i) The Commissioner. 
‘‘(ii) The Director of the National In-
stitutes of Health. 
‘‘(iii) The Director of the Centers for 
Disease Control and Prevention. 
‘‘(iv) The Director of the Agency for 
Healthcare Research and Quality. 
‘‘(C) APPOINTED MEMBERS.— 
‘‘(i) IN
GENERAL.—The ex officio 
members of the Board under subparagraph 
(B) shall, by majority vote, appoint to the 
Board 14 individuals, of which 9 shall be 
from a list of candidates to be provided by 
the National Academy of Sciences and 5 
shall be from lists of candidates provided 
by patient and consumer advocacy groups, 
professional scientific and medical soci-
eties, and industry trade organizations. Of 
such appointed members— 
‘‘(I) 4 shall be representatives of 
the general pharmaceutical, device, 
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food, cosmetic, and biotechnology in-
dustries; 
‘‘(II) 3 shall be representatives of 
academic research organizations; 
‘‘(III) 2 shall be representatives 
of patient or consumer advocacy orga-
nizations; 
‘‘(IV) 1 shall be a representative 
of health care providers; and 
‘‘(V) 4 shall be at-large members 
with expertise or experience relevant 
to the purpose of the Foundation. 
‘‘(ii) REQUIREMENTS.— 
‘‘(I) EXPERTISE.—The ex officio 
members shall ensure the Board mem-
bership includes individuals with ex-
pertise in areas including the sciences 
of developing, manufacturing, and 
evaluating the safety and effectiveness 
of devices, including diagnostics, bio-
logics, and drugs, and the safety of 
food, food ingredients, and cosmetics. 
‘‘(II) FEDERAL
EMPLOYEES.— 
No employee of the Federal Govern-
ment shall be appointed as a member 
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of the Board under this subparagraph 
or under paragraph (3)(B). 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN GENERAL.—Not later than 30 
days after the date of the enactment of 
this subchapter, the Secretary shall con-
vene a meeting of the ex officio members 
of the Board to— 
‘‘(I) incorporate the Foundation; 
and 
‘‘(II) appoint the members of the 
Board in accordance with subpara-
graph (C). 
‘‘(ii) SERVICE OF EX OFFICIO MEM-
BERS.—Upon the appointment of the 
members of the Board under clause 
(i)(II)— 
‘‘(I) the terms of service of the 
Director of the Centers for Disease 
Control and Prevention and of the Di-
rector of the Agency for Healthcare 
Research and Quality as ex officio 
members of the Board shall termi-
nate; and 
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‘‘(II) the Commissioner and the 
Director of the National Institutes of 
Health shall continue to serve as ex 
officio members of the Board, but 
shall be nonvoting members. 
‘‘(iii) CHAIR.—The ex officio members 
of the Board under subparagraph (B) shall 
designate an appointed member of the 
Board to serve as the Chair of the Board. 
‘‘(2) DUTIES OF BOARD.—The Board shall— 
‘‘(A) establish bylaws for the Foundation 
that— 
‘‘(i) are published in the Federal Reg-
ister and available for public comment; 
‘‘(ii) establish policies for the selection 
of the officers, employees, agents, and con-
tractors of the Foundation; 
‘‘(iii) establish policies, including eth-
ical standards, for the acceptance, solicita-
tion, and disposition of donations and 
grants to the Foundation and for the dis-
position of the assets of the Foundation, 
including appropriate limits on the ability 
of donors to designate, by stipulation or re-
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‘‘(B) prioritize and provide overall direc-
tion to the activities of the Foundation; 
‘‘(C) evaluate the performance of the Exec-
utive Director; and 
‘‘(D) carry out any other necessary activi-
ties regarding the functioning of the Founda-
tion. 
‘‘(3) TERMS AND VACANCIES.— 
‘‘(A) TERM.—The term of office of each 
member of the Board appointed under para-
graph (1)(C) shall be 4 years, except that the 
terms of offices for the initial appointed mem-
bers of the Board shall expire on a staggered 
basis as determined by the ex officio members. 
‘‘(B) VACANCY.—Any vacancy in the mem-
bership of the Board— 
‘‘(i) shall not affect the power of the 
remaining members to execute the duties 
of the Board; and 
‘‘(ii) shall be filled by appointment by 
the appointed members described in para-
graph (1)(C) by majority vote. 
‘‘(C) PARTIAL TERM.—If a member of the 
Board does not serve the full term applicable 
under subparagraph (A), the individual ap-
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pointed under subparagraph (B) to fill the re-
sulting vacancy shall be appointed for the re-
mainder of the term of the predecessor of the 
individual. 
‘‘(D) SERVING PAST TERM.—A member of 
the Board may continue to serve after the expi-
ration of the term of the member until a suc-
cessor is appointed. 
‘‘(4) COMPENSATION.—Members of the Board 
may not receive compensation for service on the 
Board. Such members may be reimbursed for travel, 
subsistence, and other necessary expenses incurred 
in carrying out the duties of the Board, as set forth 
in the bylaws issued by the Board. 
‘‘(e) INCORPORATION.—The ex officio members of the 
Board shall serve as incorporators and shall take whatever 
actions necessary to incorporate the Foundation. 
‘‘(f) NONPROFIT STATUS.—In carrying out sub-
section (b), the Board shall establish such policies and by-
laws under subsection (d), and the Executive Director 
shall carry out such activities under subsection (g), as may 
be necessary to ensure that the Foundation maintains sta-
tus as an organization that— 
‘‘(1) is described in subsection (c)(3) of section 
501 of the Internal Revenue Code of 1986; and 
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‘‘(2) is, under subsection (a) of such section, ex-
empt from taxation. 
‘‘(g) EXECUTIVE DIRECTOR.— 
‘‘(1) IN GENERAL.—The Board shall appoint an 
Executive Director who shall serve at the pleasure of 
the Board. The Executive Director shall be respon-
sible for the day-to-day operations of the Foundation 
and shall have such specific duties and responsibil-
ities as the Board shall prescribe. 
‘‘(2) COMPENSATION.—The compensation of 
the Executive Director shall be fixed by the Board 
but shall not be greater than the compensation of 
the Commissioner. 
‘‘(h) ADMINISTRATIVE POWERS.—In carrying out 
this subchapter, the Board, acting through the Executive 
Director, may— 
‘‘(1) adopt, alter, and use a corporate seal, 
which shall be judicially noticed; 
‘‘(2) hire, promote, compensate, and discharge 
1 or more officers, employees, and agents, as may be 
necessary, and define their duties; 
‘‘(3) prescribe the manner in which— 
‘‘(A) real or personal property of the 
Foundation is acquired, held, and transferred; 
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‘‘(B) general operations of the Foundation 
are to be conducted; and 
‘‘(C) the privileges granted to the Board 
by law are exercised and enjoyed; 
‘‘(4) with the consent of the applicable executive 
department or independent agency, use the informa-
tion, services, and facilities of such department or 
agencies in carrying out this section; 
‘‘(5) enter into contracts with public and pri-
vate organizations for the writing, editing, printing, 
and publishing of books and other material; 
‘‘(6) hold, administer, invest, and spend any 
gift, devise, or bequest of real or personal property 
made to the Foundation under subsection (i); 
‘‘(7) enter into such other contracts, leases, co-
operative agreements, and other transactions as the 
Board considers appropriate to conduct the activities 
of the Foundation; 
‘‘(8) modify or consent to the modification of 
any contract or agreement to which it is a party or 
in which it has an interest under this subchapter; 
‘‘(9) take such action as may be necessary to 
obtain patents and licenses for devices and proce-
dures developed by the Foundation and its employ-
ees; 
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‘‘(10) sue and be sued in its corporate name, 
and complain and defend in courts of competent ju-
risdiction; 
‘‘(11) appoint other groups of advisors as may 
be determined necessary to carry out the functions 
of the Foundation; and 
‘‘(12) exercise other powers as set forth in this 
section, and such other incidental powers as are nec-
essary to carry out its powers, duties, and functions 
in accordance with this subchapter. 
‘‘(i) 
ACCEPTANCE
OF
FUNDS
FROM
OTHER 
SOURCES.—The Executive Director may solicit and accept 
on behalf of the Foundation, any funds, gifts, grants, de-
vises, or bequests of real or personal property made to the 
Foundation, including from private entities, for the pur-
poses of carrying out the duties of the Foundation. 
‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal 
Government employees may serve on committees advisory 
to the Foundation and otherwise cooperate with and assist 
the Foundation in carrying out its functions, so long as 
such employees do not direct or control Foundation activi-
ties. 
‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FEL-
LOWSHIPS.— 
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