119 
quest under subparagraph (C), does not agree 
to make a labeling change requested by the 
Commissioner, the Commissioner may deem the 
drug that is the subject of the application to be 
misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Noth-
ing in this subsection limits the authority of the 
United States to bring an enforcement action 
under this Act when a drug lacks appropriate 
pediatric labeling. Neither course of action (the 
Pediatric Advisory Committee process or an en-
forcement action referred to in the preceding 
sentence) shall preclude, delay, or serve as the 
basis to stay the other course of action. 
‘‘(3) OTHER
LABELING
CHANGES.—If, on or 
after the date of enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary makes a 
determination that a pediatric assessment conducted 
under this section does or does not demonstrate that 
the drug that is the subject of such assessment is 
safe and effective in pediatric populations or sub-
populations, including whether such assessment re-
sults are inconclusive, the Secretary shall order the 
label of such product to include information about
120 
the results of the assessment and a statement of the 
Secretary’s determination. 
‘‘(h) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a pediatric assess-
ment under this section, the Secretary shall make 
available to the public in an easily accessible manner 
the medical, statistical, and clinical pharmacology re-
views of such pediatric assessments, and shall post 
such assessments on the website of the Food and 
Drug Administration. 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of enactment of the Pediatric Research Equity 
Act of 2007, the Secretary shall require that the 
sponsors of the assessments that result in labeling 
changes that are reflected in the annual summary 
developed pursuant to subsection (f)(6)(H) dis-
tribute such information to physicians and other 
health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection shall alter or amend Section 301(j) of 
this Act or section 552 of title 5 or section 1905 of 
title 18, United States Code.
121 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of enactment of the Pediatric Research Eq-
uity Act of 2007, during the one-year period begin-
ning on the date a labeling change is made pursuant 
to subsection (g), the Secretary shall ensure that all 
adverse event reports that have been received for 
such drug (regardless of when such report was re-
ceived) are referred to the Office of Pediatric Thera-
peutics. In considering the report, the Director of 
such Office shall provide for the review of the report 
by the Pediatric Advisory Committee, including ob-
taining any recommendations of such committee re-
garding whether the Secretary should take action 
under this Act in response to such report. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol-
lowing the one-year period described in paragraph 
(1), the Secretary shall, as appropriate, refer to the 
Office of Pediatric Therapeutics all pediatric adverse 
event reports for a drug for which a pediatric study 
was conducted under this section. In considering the 
report, the Director of such Office may provide for 
the review of the report by the Pediatric Advisory 
Committee, including obtaining any recommendation
122 
of such Committee regarding whether the Secretary 
should take action in response to such report. 
‘‘(3) EFFECT.—The requirements of this sub-
section shall supplement, not supplant, other review 
of such adverse event reports by the Secretary. 
‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section 
provides to the Secretary any authority to require a pedi-
atric assessment of any drug or biological product, or any 
assessment regarding other populations or uses of a drug 
or biological product, other than the pediatric assessments 
described in this section. 
‘‘(k) ORPHAN DRUGS.—Unless the Secretary re-
quires otherwise by regulation, this section does not apply 
to any drug for an indication for which orphan designation 
has been granted under section 526. 
‘‘(l) INSTITUTE OF MEDICINE STUDY.— 
‘‘(1) IN GENERAL.—Not later than three years 
after the date of the enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary shall con-
tract with the Institute of Medicine to conduct a 
study and report to Congress regarding the pediatric 
studies conducted pursuant to this section since 
1997 and labeling changes made as a result of such 
studies.
123 
‘‘(2) CONTENT OF STUDY.—The study under 
paragraph (1) shall review and assess the use of ex-
trapolation for pediatric subpopulations, the use of 
alternative endpoints for pediatric populations, neo-
natal assessment tools, the number and type of pedi-
atric adverse events, and ethical issues in pediatric 
clinical trials. 
‘‘(3) REPRESENTATIVE SAMPLE.—The Institute 
of Medicine may devise an appropriate mechanism to 
review a representative sample of studies conducted 
pursuant to this section from each review division 
within the Center for Drug Evaluation and Research 
in order to make the requested assessment.’’. 
(b) APPLICABILITY.—The amendment made in sub-
section (a) applies to assessments required under section 
505B on or after the date of enactment of this Act. 
SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE RE-
PORT. 
Not later than September 1, 2011, the Comptroller 
General of the United States, in consultation with the Sec-
retary of Health and Human Services, shall submit to the 
Congress a report that addresses the effectiveness of sec-
tions 505A and 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a, 355c) and section 409I of the 
Public Health Service Act (42 U.S.C. 284m) in ensuring
124 
that medicines used by children are tested and properly 
labeled. Such report shall include— 
(1) the number and importance of drugs and 
biological products for children that are being tested 
as a result of the amendments made by this title and 
title V and the importance for children, health care 
providers, parents, and others of labeling changes 
made as a result of such testing; 
(2) the number and importance of drugs and 
biological products for children that are not being 
tested for their use notwithstanding the provisions of 
this title and title V and possible reasons for the 
lack of testing, including whether the number of 
written requests declined by sponsors or holders of 
drugs subject to section 505A(g)(2) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355a(g)(2)) has increased or decreased as a result of 
the amendments made by this title; 
(3) the number of drugs and biological products 
for which testing is being done and labeling changes 
required, including the date labeling changes are 
made and which labeling changes required the use of 
the dispute resolution process established pursuant 
to the amendments made by this title, together with 
a description of the outcomes of such process, in-