125 
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 
(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’’.
126 
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. 
‘‘(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
127 
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 
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
128 
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-
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-
129 
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.— 
‘‘(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
130 
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 
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—
131 
‘‘(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, 
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
132 
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-
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.
133 
‘‘(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-
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
134 
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. 
‘‘(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
135 
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 
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
136 
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 
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).
137 
‘‘(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-
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;
138 
‘‘(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 
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—
139 
‘‘(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 
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.
140 
‘‘(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— 
‘‘(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—
141 
‘‘(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 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
142 
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-
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
143 
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 
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-
144 
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 
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
145 
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 
‘‘(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-