H. R. 3580—61 
‘‘(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 Pharmaceuticals 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 Pediatric Thera-
peutics established under section 6 of the Best Pharmaceuticals 
for Children Act (Public Law 107–109). In considering the 
reports, the Director of such Office shall provide for the review 
of the 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 reports. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following 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 provide for the 
review of such reports by the Pediatric Advisory Committee, 
including obtaining any recommendation of such Committee 
regarding whether the Secretary should take action in response 
to such reports. 
‘‘(3) EFFECT.—The requirements of this subsection 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 EXCLUSIVITY 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 exclusivity 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 application 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 exclusivity period. 
‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.— 
‘‘(1) IN GENERAL.—Beginning on the date of the enactment 
of the Best Pharmaceuticals for Children Act of 2007, if pedi-
atric studies of a drug have not been completed under sub-
section (d) and if the Secretary, through the committee estab-
lished 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 following:
H. R. 3580—62 
‘‘(A) For a drug for which a listed patent has not 
expired, make a determination regarding whether an 
assessment shall be required to be submitted under section 
505B(b). Prior to making such a determination, the Sec-
retary may not take more than 30 days to certify whether 
the Foundation for the National Institutes 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 
National 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 Secretary certifies that funds are not 
sufficient to initiate and fund all the studies in their 
entirety, the Secretary shall consider whether assessments 
shall be required under section 505B(b) for such drug. 
‘‘(B) For a drug that has no listed patents or has 
1 or more listed patents that have expired, the Secretary 
shall refer the drug for inclusion 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 LABELING.— 
‘‘(1) GENERAL RULE.—A drug for which an application has 
been submitted or approved under section 505(j) shall not be 
considered ineligible for approval under that section or mis-
branded under section 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 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 marketing exclusivity 
for a manufacturer— 
‘‘(i) the drug is not labeled for pediatric use; or 
‘‘(ii) in the case of a drug for which there is an 
additional pediatric use not referred to in paragraph 
(1), the drug is not labeled for the pediatric use under 
paragraph (1); and 
‘‘(B) a statement of any appropriate pediatric contra-
indications, warnings, or precautions that the Secretary 
considers necessary. 
‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER 
PROVISIONS.—This subsection does not affect—
H. R. 3580—63 
‘‘(A) the availability or scope of exclusivity under this 
section; 
‘‘(B) the availability or scope of exclusivity under sec-
tion 505 for pediatric formulations; 
‘‘(C) the question of the eligibility for approval of any 
application under section 505(j) that omits any other condi-
tions of approval entitled to exclusivity under clause (iii) 
or (iv) of section 505(j)(5)(F); or 
‘‘(D) except as expressly provided in paragraphs (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 subsections (b) and (c); 
‘‘(2) review and assess such representative pediatric studies 
conducted under subsections (b) and (c) since 1997 and labeling 
changes made as a result of such studies; 
‘‘(3) review the use of extrapolation for pediatric subpopula-
tions, the use of alternative endpoints for pediatric populations, 
neonatal assessment tools, and ethical issues in pediatric clin-
ical 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 appropriate incen-
tives 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 Secretary makes 
a written request for pediatric studies of the drug; 
‘‘(2) on or before October 1, 2012, an application 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 sub-
section shall apply to written requests under section 505A 
of the Federal Food, 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 enactment of this Act, which has been accepted and 
for which no determination under subsection (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
H. R. 3580—64 
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.— 
‘‘(1) IN GENERAL.—Not later than one year after the date 
of the enactment of the Best Pharmaceuticals for Children 
Act of 2007, the Secretary, acting through the Director of the 
National Institutes of Health and in consultation with the 
Commissioner of Food and Drugs and experts in pediatric 
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 INFORMATION.—In devel-
oping and prioritizing the list under paragraph (1), the Sec-
retary shall consider— 
‘‘(A) therapeutic gaps in pediatrics that may include 
developmental 
pharmacology, 
pharmacogenetic 
deter-
minants of drug response, metabolism of drugs and bio-
logics in children, and pediatric clinical trials; 
‘‘(B) particular pediatric diseases, disorders or condi-
tions where more complete knowledge and testing of thera-
peutics, including drugs and biologics, may be beneficial 
in pediatric populations; and 
‘‘(C) the adequacy of necessary infrastructure to con-
duct pediatric pharmacological research, 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 expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, labora-
tories, 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 Institutes of Health shall, as 
appropriate, submit proposed pediatric study requests for 
consideration by the Commissioner of Food and Drugs for pedi-
atric 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 (c) of section 505A of the Federal 
Food, Drug, and Cosmetic Act, including with respect to the 
information provided on the pediatric studies to be conducted 
pursuant to the request. The Director of the National Institutes 
of Health may submit a proposed pediatric study request for 
a drug for which—