H. R. 3580—51 
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 requested by the Commissioner, the Commis-
sioner shall refer the matter to the Pediatric Advisory 
Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving 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 labeling changes, if any. 
‘‘(C) 
CONSIDERATION
OF
RECOMMENDATIONS.—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 application or supplement 
to make any labeling changes that the Commissioner deter-
mines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the application 
or supplement, within 30 days after receiving a request 
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 
or supplement to be misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub-
section 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 enforcement 
action referred to in the preceding sentence) shall preclude, 
delay, or serve as the basis to stay the other course of 
action. 
‘‘(2) OTHER LABELING CHANGES.—If, on or after the date 
of the enactment of the Pediatric Research Equity Act of 2007, 
the Secretary makes a determination that a pediatric assess-
ment 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 subpopulations, 
including whether such assessment results are inconclusive, 
the Secretary shall order the label of such product to include 
information about the results of the assessment and a state-
ment of the Secretary’s determination. 
‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.— 
‘‘(1) IN GENERAL.—Not later than 210 days after the date 
of submission of a pediatric assessment under this section, 
the Secretary shall make available to the public in an easily 
accessible manner the medical, statistical, and clinical pharma-
cology reviews of such pediatric assessments, and shall post 
such assessments on the Web site of the Food and Drug 
Administration. 
‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING 
CHANGES.—Beginning on the date of the enactment of the Pedi-
atric Research Equity Act of 2007, the Secretary shall require 
that the sponsors of the assessments that result in labeling
H. R. 3580—52 
changes that are reflected in the annual summary developed 
pursuant to subsection (f)(6)(H) distribute 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 beginning 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 received) 
are referred to the Office of Pediatric Therapeutics. In consid-
ering such reports, the Director of such Office shall provide 
for the review of such reports by the Pediatric Advisory Com-
mittee, including obtaining any recommendations of such com-
mittee 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. 
‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section provides 
to the Secretary any authority to require a pediatric 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 requires otherwise 
by regulation, this section does not apply to any drug for an indica-
tion 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 Research Equity Act 
of 2007, the Secretary shall contract with the Institute of Medi-
cine to conduct a study and report to Congress regarding the 
pediatric studies conducted pursuant to this section or precursor 
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 extrapolation for pediatric 
subpopulations, the use of alternative endpoints for pediatric 
populations, neonatal assessment tools, the number and type 
of pediatric adverse events, and ethical issues in pediatric clin-
ical trials.
H. R. 3580—53 
‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine 
may devise an appropriate mechanism to review a representa-
tive 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
STUDIES.—The 
authority under this section shall remain in effect 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.— 
(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 required 
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
REQUESTS.—An 
assessment pending on or after the date that is 1 year prior 
to the date of the enactment of this Act shall be subject to 
the tracking and disclosure requirements established under 
such section 505B, as in effect on or after such date of enact-
ment, except that any such assessments submitted or waivers 
of such assessments requested before 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: 
‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC 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 pediatrics (including representation from the Office 
of Pediatric Therapeutics), biopharmacology, statistics, chemistry, 
legal issues, pediatric ethics, and the appropriate expertise per-
taining to the pediatric product under review, such as expertise 
in child and adolescent psychiatry, and other individuals designated 
by the Secretary.’’. 
SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 
Not later than January 1, 2011, the Comptroller General of 
the United States, in consultation with the Secretary of Health 
and Human Services, shall submit to the Congress a report that 
addresses the effectiveness of sections 505A and 505B of the Federal 
Food, Drug, and Cosmetic 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
H. R. 3580—54 
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, including a 
description of the disputes and the recommendations 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 
Secretary determines to be appropriate, including a detailed 
rationale for each recommendation; and 
(5)(A) the efforts made by the Secretary to increase 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 studies 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 PHARMACEUTICALS 
FOR CHILDREN ACT OF 2007 
SEC. 501. SHORT TITLE. 
This title may be cited as the ‘‘Best Pharmaceuticals for Chil-
dren Act of 2007’’. 
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL-
DREN 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 include pharmacokinetic studies) 
in pediatric age groups (including neonates in appropriate cases) 
in which a drug is anticipated to be used, and, at the discretion 
of the Secretary, may include preclinical studies. 
‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (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
H. R. 3580—55 
include a timeframe for completing such studies), the applicant 
agrees to the request, such studies are completed using appro-
priate 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 subsection (c)(3)(E)(ii) 
of section 505, and in subsection (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 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 section 526 for 
a rare disease or condition, the period 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 certification has 
been submitted under subsection (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 extensions); or 
‘‘(II) a listed patent for which a certification has 
been submitted under subsections (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 (including any patent extensions); 
or 
‘‘(ii) if the drug is the subject of a listed patent for 
which a certification has been submitted under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
patent infringement litigation resulting from the certifi-
cation the court determines that the patent is valid and 
would be infringed, 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 (including any patent 
extensions). 
‘‘(2) EXCEPTION.—The Secretary shall not extend 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 expiration of such period. 
‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 
if the Secretary determines that information 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
H. R. 3580—57 
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 pediatric studies for such drug. In issuing 
such request, the Secretary shall take into account ade-
quate representation of children of ethnic and racial minori-
ties. Such request to conduct pediatric studies shall be 
in writing and shall include a timeframe for such studies 
and a request to the sponsor or holder to propose pediatric 
labeling resulting from such studies. 
‘‘(B) SINGLE
WRITTEN
REQUEST.—A single 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 STUDIES.— 
‘‘(A) REQUEST AND RESPONSE.— 
‘‘(i) IN GENERAL.—If the Secretary makes a written 
request for pediatric studies (including neonates, as 
appropriate) under subsection (b) or (c), the applicant 
or holder, not later than 180 days after receiving 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 applicant or holder agrees to 
the request; or 
‘‘(II) indicating that the applicant or holder 
does not agree to the request and stating the rea-
sons 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 formu-
lation, the applicant or holder shall submit to the 
Secretary the reasons such pediatric formulation 
cannot be developed. 
‘‘(B) ADVERSE EVENT REPORTS.—An applicant 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 submission 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 
accepting 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 com-
monly accepted scientific principles and protocols, and have 
been reported in accordance with the requirements of the Sec-
retary for filing.
H. R. 3580—58 
‘‘(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 REQUIREMENT.— 
‘‘(1) IN
GENERAL.—The Secretary shall publish a notice 
of any determination, made on or after the date of the enact-
ment 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 section 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 enactment of the Best Pharmaceuticals 
for Children Act of 2007, a pediatric formulation was developed, 
studied, and found to be safe and effective in the pediatric 
population (or specified subpopulation) if the pediatric formula-
tion for such drug is not introduced onto the market within 
one year after the date that the Secretary publishes the notice 
described in paragraph (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 accept or reject such reports under sub-
section (d)(3). 
‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to 
in paragraph (1) may operate using appropriate members of 
such committee and need not convene all members of the com-
mittee. 
‘‘(5) DOCUMENTATION
OF
COMMITTEE
ACTION.—For each 
drug, the committee referred to in paragraph (1) shall docu-
ment, for each activity described in paragraph (2) or (3), which 
members of the committee participated in such activity. 
‘‘(6) 
TRACKING
PEDIATRIC
STUDIES
AND
LABELING 
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 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 drug uses, including labeled 
and off-labeled indications, studied under such sections;
H. R. 3580—59 
‘‘(C) the types of studies conducted under such sections, 
including trial design, the number of pediatric patients 
studied, and the number of centers and countries involved; 
‘‘(D) the number of pediatric formulations developed 
and the number of pediatric formulations not developed 
and the reasons such formulations 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 submitted 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 subsection (b) or (c) has already 
been applied— 
‘‘(1) may receive an additional six-month period under sub-
section (c)(1)(A)(i)(II) for a supplemental application if all other 
requirements under this section are satisfied, except that such 
drug may not receive any additional such period under sub-
section (c)(1)(B); and 
‘‘(2) may not receive any additional such period under 
subsection (c)(1)(A)(ii). 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.— 
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
APPLICATIONS
AND 
SUPPLEMENTS.—Any application or supplement to an applica-
tion under section 505 proposing 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 estab-
lished by the Commissioner for priority 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 Pharmaceuticals for Children Act of 2007, the 
Commissioner determines that the sponsor and the 
Commissioner have been unable to reach agreement 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 submission 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
H. R. 3580—60 
make a labeling change requested by the Commis-
sioner, the Commissioner shall refer the matter to 
the Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving 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 labeling changes, if any. 
‘‘(C) 
CONSIDERATION
OF
RECOMMENDATIONS.—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 application to make any 
labeling change that the Commissioner determines to be 
appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the application, 
within 30 days after receiving a request under subpara-
graph (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.—Nothing in this sub-
section 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 enforcement 
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 pediatric 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 subpopulations, 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 INFORMATION.— 
‘‘(1) IN GENERAL.—Not later than 210 days after the date 
of submission of a report on a pediatric study under this section, 
the Secretary shall make available to the public the medical, 
statistical, and clinical pharmacology reviews of pediatric 
studies conducted under subsection (b) or (c). 
‘‘(2) DISSEMINATION OF INFORMATION REGARDING 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 sponsors 
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 determines that it would be beneficial to the 
public health), such information to physicians and other health 
care providers.