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review under clause (i) shall promptly be 
made available to the public in an easily 
accessible manner, including through the 
website of the Food and Drug Administra-
tion. 
‘‘(4) WAIVERS.— 
‘‘(A) FULL WAIVER.—On the initiative of 
the Secretary or at the request of an applicant, 
the Secretary shall grant a full waiver, as ap-
propriate, of the requirement to submit assess-
ments for a drug or biological product under 
this subsection if the applicant certifies and the 
Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients is so small or 
the patients are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups; or 
‘‘(iii) The drug or biological product— 
‘‘(I) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients; and 
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‘‘(II) is not likely to be used in a 
substantial number of pediatric pa-
tients. 
‘‘(B) PARTIAL WAIVER.—On the initiative 
of the Secretary or at the request of an appli-
cant, the Secretary shall grant a partial waiver, 
as appropriate, of the requirement to submit as-
sessments for a drug or biological product 
under this subsection with respect to a specific 
pediatric age group if the applicant certifies 
and the Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients in that age 
group is so small or patients in that age 
group are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in that age 
group; 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients in that 
age group; and 
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‘‘(II) is not likely to be used by 
a substantial number of pediatric pa-
tients in that age group; or 
‘‘(iv) the applicant can demonstrate 
that reasonable attempts to produce a pe-
diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible 
manner, including through posting on the 
website of the Food and Drug Administration. 
‘‘(D) LABELING
REQUIREMENT.—If the 
Secretary grants a full or partial waiver because 
there is evidence that a drug or biological prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
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in the labeling for the drug or biological prod-
uct. 
‘‘(b) MARKETED DRUGS
AND BIOLOGICAL PROD-
UCTS.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
enactment of the Pediatric Research Equity Act of 
2007, after providing notice in the form of a letter 
and an opportunity for written response and a meet-
ing, which may include an advisory committee meet-
ing, the Secretary may (by order in the form of a 
letter) require the sponsor or holder of an approved 
application for a drug under section 505 or the hold-
er of a license for a biological product under section 
351 of the Public Health Service Act to submit by 
a specified date the assessments described in sub-
section (a)(2), if the Secretary finds that— 
‘‘(A)(i) the drug or biological product is 
used for a substantial number of pediatric pa-
tients for the labeled indications; and 
‘‘(ii) adequate pediatric labeling could con-
fer a benefit on pediatric patients; 
‘‘(B) there is reason to believe that the 
drug or biological product would represent a 
meaningful therapeutic benefit over existing 
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therapies for pediatric patients for 1 or more of 
the claimed indications; or 
‘‘(C) the absence of adequate pediatric la-
beling could pose a risk to pediatric patients. 
‘‘(2) WAIVERS.— 
‘‘(A) FULL WAIVER.—At the request of an 
applicant, the Secretary shall grant a full waiv-
er, as appropriate, of the requirement to submit 
assessments under this subsection if the appli-
cant certifies and the Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients in that age 
group is so small or patients in that age 
group are geographically dispersed); or 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups. 
‘‘(B) PARTIAL WAIVER.—At the request of 
an applicant, the Secretary shall grant a partial 
waiver, as appropriate, of the requirement to 
submit assessments under this subsection with 
respect to a specific pediatric age group if the 
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applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients in that age 
group is so small or patients in that age 
group are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in that age 
group; 
‘‘(iii)(I) the drug or biological prod-
uct— 
‘‘(aa) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients in that 
age group; and 
‘‘(bb) is not likely to be used in 
a substantial number of pediatric pa-
tients in that age group; and 
‘‘(II) the absence of adequate labeling 
could not pose significant risks to pediatric 
patients; or 
‘‘(iv) the applicant can demonstrate 
that reasonable attempts to produce a pe-
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diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible 
manner, including through posting on the 
website of the Food and Drug Administration. 
‘‘(D) LABELING
REQUIREMENT.—If the 
Secretary grants a full or partial waiver because 
there is evidence that a drug or biological prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
in the labeling for the drug or biological prod-
uct. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For 
the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) 
of 
subsection 
(a) 
and 
paragraphs 
(1)(B)(I) 
and 
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(2)(B)(iii)(I)(aa) of subsection (b), a drug or biological 
product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary 
determines that— 
‘‘(1) if approved, the drug or biological product 
could represent an improvement in the treatment, 
diagnosis, or prevention of a disease, compared with 
marketed products adequately labeled for that use in 
the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class 
of products or for an indication for which there is 
a need for additional options. 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 
fails to submit an assessment described in subsection 
(a)(2), or a request for approval of a pediatric formulation 
described in subsection (a) or (b), in accordance with ap-
plicable provisions of subsections (a) and (b)— 
‘‘(1) the drug or biological product that is the 
subject of the assessment or request may be consid-
ered misbranded solely because of that failure and 
subject to relevant enforcement action (except that 
the drug or biological product shall not be subject to 
action under section 303); but 
‘‘(2) the failure to submit the assessment or re-
quest shall not be the basis for a proceeding— 
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‘‘(A) to withdraw approval for a drug 
under section 505(e); or 
‘‘(B) to revoke the license for a biological 
product under section 351 of the Public Health 
Service Act. 
‘‘(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, DEFERRALS, 
AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 
days after the date of enactment of the Pediatric 
Research Equity Act of 2007, the Secretary shall 
utilize an internal committee to provide consultation 
to reviewing divisions on all pediatric plans and as-
sessments prior to approval of an application or sup-
plement for which a pediatric assessment is required 
under this section and all deferral and waiver re-
quests granted pursuant to this section. Such inter-
nal committee shall include employees of the Food 
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and Drug Administration, with expertise in pediat-
rics (including representation from the Office of Pe-
diatric Therapeutics), biopharmacology, statistics, 
chemistry, legal issues, pediatric ethics, and the ap-
propriate expertise pertaining to the pediatric prod-
uct under review, and other individuals designated 
by the Secretary. 
‘‘(2) ACTIVITY BY COMMITTEE.—The committee 
referred to in paragraph (1) may operate using ap-
propriate members of such committee and need not 
convene all members of the committee. 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
AC-
TION.—For each drug or biological product, the 
committee referred to in paragraph (1) shall docu-
ment, for each activity described in paragraph (4), 
which members of the committee participated in 
such activity. 
‘‘(4) REVIEW OF PEDIATRIC PLANS, DEFERRALS 
AND WAIVERS.—Consultation on pediatric plans and 
assessments by the internal committee pursuant to 
this section shall occur prior to approval of an appli-
cation or supplement for which a pediatric assess-
ment is required under this section. The internal 
committee shall review all requests for deferrals and 
waivers from the requirement to submit a pediatric 
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assessment granted under this section and shall pro-
vide recommendations as needed to reviewing divi-
sions. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC 
PLANS, DEFERRALS AND WAIVERS.—Within one year 
after enactment of the Pediatric Research Equity 
Act of 2007, the committee shall conduct a retro-
spective review and analysis of a representative sam-
ple of assessments submitted and deferrals and 
waivers approved under this section since enactment 
of the Pediatric Research Equity Act of 2003. Such 
review shall include an analysis of the quality and 
consistency of pediatric information in pediatric as-
sessments and the appropriateness of waivers and 
deferrals granted. Based on such review, the Sec-
retary shall issue recommendations to the review di-
visions for improvements and initiate guidance to in-
dustry related to the scope of pediatric studies re-
quired under this section. 
‘‘(6) TRACKING OF ASSESSMENTS AND LABEL-
ING CHANGES.—Beginning on the date of enactment 
of the Pediatric Research Equity Act of 2007, the 
Secretary shall track and make available to the pub-
lic in an easily accessible manner, including through 
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posting on the website of the Food and Drug Ad-
ministration— 
‘‘(A) the number of assessments conducted 
under this section; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses assessed under this section; 
‘‘(C) the types of assessments conducted 
under this section, including trial design, the 
number of pediatric patients studied, and the 
number of centers and countries involved; 
‘‘(D) the total number of deferrals re-
quested and granted under this section and, if 
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); and 
‘‘(I) an annual summary of information 
submitted pursuant to subsection (a)(3)(B). 
‘‘(7) 
COMMITTEE.—The 
committee 
utilized 
under paragraph (1) shall be the committee estab-
lished under section 505A(f)(1). 
‘‘(g) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS.—Any supplement to an application under 
section 505 and section 351 of the Public Health 
Service Act proposing a labeling change as a result 
of any pediatric assessments conducted pursuant to 
this section— 
‘‘(A) shall be considered a priority applica-
tion or supplement; and 
‘‘(B) shall be subject to the performance 
goals established by the Commissioner for pri-
ority drugs. 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of enactment of the Pediatric Research 
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Equity Act of 2007, the Commissioner deter-
mines that a sponsor and the Commissioner 
have been unable to reach agreement on appro-
priate changes to the labeling for the drug that 
is the subject of the application or supplement, 
not later than 180 days after the date of the 
submission of the application or supplement— 
‘‘(i) the Commissioner shall request 
that the sponsor of the application make 
any labeling change that the Commissioner 
determines to be appropriate; and 
‘‘(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 
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‘‘(ii) make a recommendation to the 
Commissioner concerning appropriate la-
beling changes, if any. 
‘‘(C) CONSIDERATION
OF
RECOMMENDA-
TIONS.—The Commissioner shall consider the 
recommendations of the Pediatric Advisory 
Committee and, if appropriate, not later than 
30 days after receiving the recommendation, 
make a request to the sponsor of the applica-
tion to make any labeling changes that the 
Commissioner determines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the 
application, within 30 days after receiving a re-
quest under subparagraph (C), does not agree 
to make a labeling change requested by the 
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 
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sentence) shall preclude, delay, or serve as the 
basis to stay the other course of action. 
‘‘(3) OTHER
LABELING
CHANGES.—If, on or 
after the date of enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary makes a 
determination that a pediatric assessment conducted 
under this section does or does not demonstrate that 
the drug that is the subject of such assessment is 
safe and effective in pediatric populations or sub-
populations, including whether such assessment re-
sults are inconclusive, the Secretary shall order the 
label of such product to include information about 
the results of the assessment and a statement of the 
Secretary’s determination. 
‘‘(h) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a pediatric assess-
ment under this section, the Secretary shall make 
available to the public in an easily accessible manner 
the medical, statistical, and clinical pharmacology re-
views of such pediatric assessments, and shall post 
such assessments on the website of the Food and 
Drug Administration. 
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‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of enactment of the Pediatric Research Equity 
Act of 2007, the Secretary shall require that the 
sponsors of the assessments that result in labeling 
changes that are reflected in the annual summary 
developed pursuant to subsection (f)(6)(H) dis-
tribute such information to physicians and other 
health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection shall alter or amend Section 301(j) of 
this Act or section 552 of title 5 or section 1905 of 
title 18, United States Code. 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of enactment of the Pediatric Research Eq-
uity Act of 2007, during the one-year period begin-
ning on the date a labeling change is made pursuant 
to subsection (g), the Secretary shall ensure that all 
adverse event reports that have been received for 
such drug (regardless of when such report was re-
ceived) are referred to the Office of Pediatric Thera-
peutics. In considering the report, the Director of 
such Office shall provide for the review of the report 
by the Pediatric Advisory Committee, including ob-
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taining any recommendations of such committee re-
garding whether the Secretary should take action 
under this Act in response to such report. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol-
lowing the one-year period described in paragraph 
(1), the Secretary shall, as appropriate, refer to the 
Office of Pediatric Therapeutics all pediatric adverse 
event reports for a drug for which a pediatric study 
was conducted under this section. In considering the 
report, the Director of such Office may provide for 
the review of the report by the Pediatric Advisory 
Committee, including obtaining any recommendation 
of such Committee regarding whether the Secretary 
should take action in response to such report. 
‘‘(3) EFFECT.—The requirements of this sub-
section shall supplement, not supplant, other review 
of such adverse event reports by the Secretary. 
‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section 
provides to the Secretary any authority to require a pedi-
atric assessment of any drug or biological product, or any 
assessment regarding other populations or uses of a drug 
or biological product, other than the pediatric assessments 
described in this section. 
‘‘(k) ORPHAN DRUGS.—Unless the Secretary re-
quires otherwise by regulation, this section does not apply 
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to any drug for an indication for which orphan designation 
has been granted under section 526. 
‘‘(l) INSTITUTE OF MEDICINE STUDY.— 
‘‘(1) IN GENERAL.—Not later than three years 
after the date of the enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary shall con-
tract with the Institute of Medicine to conduct a 
study and report to Congress regarding the pediatric 
studies conducted pursuant to this section since 
1997 and labeling changes made as a result of such 
studies. 
‘‘(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.’’. 
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(b) APPLICABILITY.—The amendment made in sub-
section (a) applies to assessments required under section 
505B on or after the date of enactment of this Act. 
SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE RE-
PORT. 
Not later than September 1, 2011, the Comptroller 
General of the United States, in consultation with the Sec-
retary of Health and Human Services, shall submit to the 
Congress a report that addresses the effectiveness of sec-
tions 505A and 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a, 355c) and section 409I of the 
Public Health Service Act (42 U.S.C. 284m) in ensuring 
that medicines used by children are tested and properly 
labeled. Such report shall include— 
(1) the number and importance of drugs and 
biological products for children that are being tested 
as a result of the amendments made by this title and 
title V and the importance for children, health care 
providers, parents, and others of labeling changes 
made as a result of such testing; 
(2) the number and importance of drugs and 
biological products for children that are not being 
tested for their use notwithstanding the provisions of 
this title and title V and possible reasons for the 
lack of testing, including whether the number of 
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written requests declined by sponsors or holders of 
drugs subject to section 505A(g)(2) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355a(g)(2)) has increased or decreased as a result of 
the amendments made by this title; 
(3) the number of drugs and biological products 
for which testing is being done and labeling changes 
required, including the date labeling changes are 
made and which labeling changes required the use of 
the dispute resolution process established pursuant 
to the amendments made by this title, together with 
a description of the outcomes of such process, in-
cluding a description of the disputes and the rec-
ommendations of the Pediatric Advisory Committee; 
(4) any recommendations for modifications to 
the programs established under sections 505A and 
505B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) that the Sec-
retary determines to be appropriate, including a de-
tailed rationale for each recommendation; and 
(5)(A) the efforts made by the Secretary to in-
crease the number of studies conducted in the 
neonate population; and 
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(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 
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. 
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‘‘(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), and if the Secretary has determined 
that labeling changes are appropriate, such changes 
are approved within the timeframe requested by the 
Secretary— 
‘‘(A)(i)(I) the period referred to in sub-
section (c)(3)(E)(ii) of section 505, and in sub-
section (j)(5)(F)(ii) of such section, is deemed 
to be five years and six months rather than five 
years, and the references in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 
four years, to forty-eight months, and to seven 
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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 
‘‘(II) a listed patent for which a cer-
tification has been submitted under sub-
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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 is made later than one 
year prior to the expiration of such period. 
‘‘(c) MARKET EXCLUSIVITY
FOR ALREADY-MAR-
KETED DRUGS.— 
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‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), if the Secretary determines that informa-
tion relating to the use of an approved drug in the 
pediatric population may produce health benefits in 
that population and makes a written request to the 
holder of an approved application under section 
505(b)(1) for pediatric studies (which shall include 
a timeframe for completing such studies), the holder 
agrees to the request, such studies are completed 
using appropriate formulations for each age group 
for which the study is requested within any such 
timeframe and the reports thereof are submitted and 
accepted in accordance with subsection (d)(3), and if 
the Secretary determines that labeling changes are 
appropriate and such changes are approved within 
the timeframe requested by the Secretary— 
‘‘(A)(i)(I) the period referred to in sub-
section (c)(3)(E)(ii) of section 505, and in sub-
section (j)(5)(F)(ii) of such section, is deemed 
to be five years and six months rather than five 
years, and the references in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to 
four years, to forty-eight months, and to seven 
and one-half years are deemed to be four and 
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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 is made later than one 
year prior to the expiration of such period. 
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 
‘‘(1) REQUEST FOR STUDIES.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after consultation with the sponsor of an appli-
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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.— 
‘‘(i) IN
GENERAL.—If the Secretary 
makes a written request for pediatric stud-
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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 
reasons such pediatric formulation cannot 
be developed. 
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‘‘(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. 
‘‘(4) 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. 
‘‘(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 
pediatric formulation for such drug is not introduced 
onto the market within one year after the date that 
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the Secretary publishes the notice described in para-
graph (1). Such notice identifying such drug shall be 
published not later than 30 days after the date of 
the expiration of such one year period. 
‘‘(f) INTERNAL REVIEW
OF WRITTEN REQUESTS 
AND PEDIATRIC STUDIES.— 
‘‘(1) INTERNAL REVIEW.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish an internal review committee to review 
all written requests issued on or after the date 
of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, in accordance with 
paragraph (2). 
‘‘(B) MEMBERS.—The committee estab-
lished under subparagraph (A) shall include in-
dividuals with expertise in pediatrics, biophar-
macology, statistics, drugs and drug formula-
tions, legal issues, pediatric ethics, the appro-
priate expertise, such as expertise in child and 
adolescent psychiatry, pertaining to the pedi-
atric product under review, one or more experts 
from the Office of Pediatric Therapeutics, and 
other individuals designated by the Secretary. 
‘‘(2) REVIEW
OF
WRITTEN
REQUESTS.—The 
committee established under paragraph (1) shall re-
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view all written requests issued pursuant to this sec-
tion prior to being issued. 
‘‘(3) TRACKING PEDIATRIC STUDIES AND LA-
BELING CHANGES.—The Secretary shall track and 
make available to the public, in an easily accessible 
manner, including through posting on the website of 
the Food and Drug Administration— 
‘‘(A) the number of studies conducted 
under this section and under section 409I of 
the Public Health Service Act; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses, including labeled and off- 
labeled indications, studied under such sections; 
‘‘(C) the types of studies conducted under 
such sections, including trial design, the num-
ber of pediatric patients studied, and the num-
ber of centers and countries involved; 
‘‘(D) the number of pediatric formulations 
developed and the number of pediatric formula-
tions not developed and the reasons such for-
mulations were not developed; 
‘‘(E) the labeling changes made as a result 
of studies conducted under such sections; 
‘‘(F) an annual summary of labeling 
changes made as a result of studies conducted 
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under such sections for distribution pursuant to 
subsection (k)(2); and 
‘‘(G) information regarding reports sub-
mitted on or after the date of the enactment of 
the Best Pharmaceuticals for Children Act of 
2007. 
‘‘(4) COMMITTEE.—The committee established 
under paragraph (1) shall be the committee utilized 
under section 505B(f)(1). 
‘‘(g) 
LIMITATIONS.—Notwithstanding 
subsection 
(c)(2), a drug to which the six-month period under sub-
section (b) or (c) has already been applied— 
‘‘(1) may receive an additional six-month period 
under subsection (c)(1)(A)(i)(II) for a supplemental 
application if all other requirements under this sec-
tion are satisfied; and 
‘‘(2) may not receive any additional such period 
under subsection (c)(1)(A)(ii). 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE-
QUIREMENTS.—Notwithstanding any other provision of 
law, if any pediatric study is required by a provision of 
law (including a regulation) other than this section and 
such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed 
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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 
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— 
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‘‘(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. 
‘‘(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-
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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. 
‘‘(j) OTHER LABELING CHANGES.—If, on or after the 
date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary determines that a pe-
diatric study conducted under this section does or does 
not demonstrate that the drug that is the subject of the 
study is safe and effective in pediatric populations or sub-
populations, including whether such study results are in-
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conclusive, the Secretary shall order the labeling of such 
product to include information about the results of the 
study and a statement of the Secretary’s determination. 
‘‘(k) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a report on a pedi-
atric study under this section, the Secretary shall 
make available to the public the medical, statistical, 
and clinical pharmacology reviews of pediatric stud-
ies conducted under subsection (b) or (c). 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, the Secretary shall include 
as a requirement of a written request that the spon-
sors of the studies that result in labeling changes 
that are reflected in the annual summary developed 
pursuant to subsection (f)(3)(F) distribute, at least 
annually (or more frequently if the Secretary deter-
mines that it would be beneficial to the public 
health), such information to physicians and other 
health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection alters or amends section 301(j) of this 
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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 
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 
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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 
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 
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‘‘(2) the date on which the 6-month exclusivity 
period expires, by the number of days of the overlap 
if the 180-day period would, but for the application 
of this subsection, expire during the six-month exclu-
sivity period. 
‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM-
PLETED.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the enactment of the Best Pharmaceuticals for Chil-
dren Act of 2007, if pediatric studies have not been 
completed under subsection (d) and if the Secretary, 
through the committee established under subsection 
(f), determines that there is a continuing need for 
information relating to the use of the drug in the pe-
diatric population (including neonates, as appro-
priate), the Secretary shall— 
‘‘(A) for a drug for which listed patents 
have not expired, make a determination regard-
ing whether an assessment shall be required to 
be submitted under section 505B; or 
‘‘(B) for a drug that has no listed patents 
or has 1 or more listed patents that have ex-
pired, determine whether there are funds avail-
able under section 736 to award a grant to con-
VerDate Aug 31 2005 
02:14 Jul 17, 2007
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