109 
group is so small or patients in that age 
group are geographically dispersed); or 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups. 
‘‘(B) PARTIAL WAIVER.—At the request of 
an applicant, the Secretary shall grant a partial 
waiver, as appropriate, of the requirement to 
submit assessments under this subsection with 
respect to a specific pediatric age group if the 
applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients in that age 
group is so small or patients in that age 
group are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in that age 
group; 
‘‘(iii)(I) the drug or biological prod-
uct—
110 
‘‘(aa) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients in that 
age group; and 
‘‘(bb) is not likely to be used in 
a substantial number of pediatric pa-
tients in that age group; and 
‘‘(II) the absence of adequate labeling 
could not pose significant risks to pediatric 
patients; or 
‘‘(iv) the applicant can demonstrate 
that reasonable attempts to produce a pe-
diatric formulation necessary for that age 
group have failed. 
‘‘(C) PEDIATRIC FORMULATION NOT POS-
SIBLE.—If a waiver is granted on the ground 
that it is not possible to develop a pediatric for-
mulation, the waiver shall cover only the pedi-
atric groups requiring that formulation. An ap-
plicant seeking either a full or partial waiver 
shall submit to the Secretary documentation de-
tailing why a pediatric formulation cannot be 
developed and, if the waiver is granted, the ap-
plicant’s submission shall promptly be made 
available to the public in an easily accessible
111 
manner, including through posting on the 
website of the Food and Drug Administration. 
‘‘(D) LABELING
REQUIREMENT.—If the 
Secretary grants a full or partial waiver because 
there is evidence that a drug or biological prod-
uct would be ineffective or unsafe in pediatric 
populations, the information shall be included 
in the labeling for the drug or biological prod-
uct. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For 
the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) 
of 
subsection 
(a) 
and 
paragraphs 
(1)(B)(I) 
and 
(2)(B)(iii)(I)(aa) of subsection (b), a drug or biological 
product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary 
determines that— 
‘‘(1) if approved, the drug or biological product 
could represent an improvement in the treatment, 
diagnosis, or prevention of a disease, compared with 
marketed products adequately labeled for that use in 
the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class 
of products or for an indication for which there is 
a need for additional options.
112 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 
fails to submit an assessment described in subsection 
(a)(2), or a request for approval of a pediatric formulation 
described in subsection (a) or (b), in accordance with ap-
plicable provisions of subsections (a) and (b)— 
‘‘(1) the drug or biological product that is the 
subject of the assessment or request may be consid-
ered misbranded solely because of that failure and 
subject to relevant enforcement action (except that 
the drug or biological product shall not be subject to 
action under section 303); but 
‘‘(2) the failure to submit the assessment or re-
quest shall not be the basis for a proceeding— 
‘‘(A) to withdraw approval for a drug 
under section 505(e); or 
‘‘(B) to revoke the license for a biological 
product under section 351 of the Public Health 
Service Act. 
‘‘(e) MEETINGS.—Before and during the investiga-
tional process for a new drug or biological product, the 
Secretary shall meet at appropriate times with the sponsor 
of the new drug or biological product to discuss— 
‘‘(1) information that the sponsor submits on 
plans and timelines for pediatric studies; or
113 
‘‘(2) any planned request by the sponsor for 
waiver or deferral of pediatric studies. 
‘‘(f) REVIEW
OF PEDIATRIC PLANS, DEFERRALS, 
AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 
days after the date of enactment of the Pediatric 
Research Equity Act of 2007, the Secretary shall 
utilize an internal committee to provide consultation 
to reviewing divisions on all pediatric plans and as-
sessments prior to approval of an application or sup-
plement for which a pediatric assessment is required 
under this section and all deferral and waiver re-
quests granted pursuant to this section. Such inter-
nal committee shall include employees of the Food 
and Drug Administration, with expertise in pediat-
rics (including representation from the Office of Pe-
diatric Therapeutics), biopharmacology, statistics, 
chemistry, legal issues, pediatric ethics, and the ap-
propriate expertise pertaining to the pediatric prod-
uct under review, and other individuals designated 
by the Secretary. 
‘‘(2) ACTIVITY BY COMMITTEE.—The committee 
referred to in paragraph (1) may operate using ap-
propriate members of such committee and need not 
convene all members of the committee.
114 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
AC-
TION.—For each drug or biological product, the 
committee referred to in paragraph (1) shall docu-
ment, for each activity described in paragraph (4), 
which members of the committee participated in 
such activity. 
‘‘(4) REVIEW OF PEDIATRIC PLANS, DEFERRALS 
AND WAIVERS.—Consultation on pediatric plans and 
assessments by the internal committee pursuant to 
this section shall occur prior to approval of an appli-
cation or supplement for which a pediatric assess-
ment is required under this section. The internal 
committee shall review all requests for deferrals and 
waivers from the requirement to submit a pediatric 
assessment granted under this section and shall pro-
vide recommendations as needed to reviewing divi-
sions. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC 
PLANS, DEFERRALS AND WAIVERS.—Within one year 
after enactment of the Pediatric Research Equity 
Act of 2007, the committee shall conduct a retro-
spective review and analysis of a representative sam-
ple of assessments submitted and deferrals and 
waivers approved under this section since enactment 
of the Pediatric Research Equity Act of 2003. Such
115 
review shall include an analysis of the quality and 
consistency of pediatric information in pediatric as-
sessments and the appropriateness of waivers and 
deferrals granted. Based on such review, the Sec-
retary shall issue recommendations to the review di-
visions for improvements and initiate guidance to in-
dustry related to the scope of pediatric studies re-
quired under this section. 
‘‘(6) TRACKING OF ASSESSMENTS AND LABEL-
ING CHANGES.—Beginning on the date of enactment 
of the Pediatric Research Equity Act of 2007, the 
Secretary shall track and make available to the pub-
lic in an easily accessible manner, including through 
posting on the website of the Food and Drug Ad-
ministration— 
‘‘(A) the number of assessments conducted 
under this section; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses assessed under this section; 
‘‘(C) the types of assessments conducted 
under this section, including trial design, the 
number of pediatric patients studied, and the 
number of centers and countries involved; 
‘‘(D) the total number of deferrals re-
quested and granted under this section and, if
116 
granted, the reasons for such deferrals, the 
timeline for completion, and the number com-
pleted and pending by the specified date, as 
outlined in subsection (a)(3); 
‘‘(E) the number of waivers requested and 
granted under this section and, if granted, the 
reasons for the waivers; 
‘‘(F) the number of pediatric formulations 
developed and the number of pediatric formula-
tions not developed and the reasons any such 
formulation was not developed; 
‘‘(G) the labeling changes made as a result 
of assessments conducted under this section; 
‘‘(H) an annual summary of labeling 
changes made as a result of assessments con-
ducted under this section for distribution pursu-
ant to subsection (h)(2); and 
‘‘(I) an annual summary of information 
submitted pursuant to subsection (a)(3)(B). 
‘‘(7) 
COMMITTEE.—The 
committee 
utilized 
under paragraph (1) shall be the committee estab-
lished under section 505A(f)(1). 
‘‘(g) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS.—Any supplement to an application under
117 
section 505 and section 351 of the Public Health 
Service Act proposing a labeling change as a result 
of any pediatric assessments conducted pursuant to 
this section— 
‘‘(A) shall be considered a priority applica-
tion or supplement; and 
‘‘(B) shall be subject to the performance 
goals established by the Commissioner for pri-
ority drugs. 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of enactment of the Pediatric Research 
Equity Act of 2007, the Commissioner deter-
mines that a sponsor and the Commissioner 
have been unable to reach agreement on appro-
priate changes to the labeling for the drug that 
is the subject of the application or supplement, 
not later than 180 days after the date of the 
submission of the application or supplement— 
‘‘(i) the Commissioner shall request 
that the sponsor of the application make 
any labeling change that the Commissioner 
determines to be appropriate; and
118 
‘‘(ii) if the sponsor does not agree 
within 30 days after the Commissioner’s 
request to make a labeling change re-
quested by the Commissioner, the Commis-
sioner shall refer the matter to the Pedi-
atric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY 
COMMITTEE.—Not later than 90 days after re-
ceiving a referral under subparagraph (A)(ii), 
the Pediatric Advisory Committee shall— 
‘‘(i) review the pediatric study reports; 
and 
‘‘(ii) make a recommendation to the 
Commissioner concerning appropriate la-
beling changes, if any. 
‘‘(C) CONSIDERATION
OF
RECOMMENDA-
TIONS.—The Commissioner shall consider the 
recommendations of the Pediatric Advisory 
Committee and, if appropriate, not later than 
30 days after receiving the recommendation, 
make a request to the sponsor of the applica-
tion to make any labeling changes that the 
Commissioner determines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the 
application, within 30 days after receiving a re-