I
104TH CONGRESS
2D SESSION
H. R. 4277
To amend the Federal Food, Drug, and Cosmetic Act to allow for additional
deferred effective dates for approval of applications under the new drugs
provisions, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 28, 1996
Mr. GREENWOOD (for himself, Mr. WAXMAN, Mr. BURR, Mr. TOWNS, Mr.
KLUG, Mr. FRANKS of New Jersey, and Mr. HALL of Texas) introduced
the following bill; which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
allow for additional deferred effective dates for approval
of applications under the new drugs provisions, and for
other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Better Pharma-
ceuticals for Children Act’’.
SEC. 2. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 505 the following new section:
‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
‘‘(a) MARKET EXCLUSIVITY FOR NEW DRUGS.—If,
prior to approval of an application that is submitted under
section 505(b)(1) the Secretary determines that informa-
tion relating to the use of a drug in the pediatric popu-
lation may produce health benefits in that population, the
Secretary makes a written request for pediatric studies
(which may include a time frame for completing such stud-
ies), and such studies are completed within any such time
frame and the reports thereof submitted in accordance
with subsection (d)(2) or completed within any such time
frame and the reports thereof are accepted in accordance
with subsection (d)(3)—
‘‘(1)(A) the period during which an application
may 
not 
be 
submitted 
under 
subsections
(c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 shall be
five years and six months rather than five years, and
the references in subsections (c)(3)(D)(ii) and
(j)(4)(D)(ii) of section 505 to four years, to forty-
eight months, and to seven and one-half years shall
be deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
‘‘(B) the period of market exclusivity under
subsections (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii)
and (iv) of section 505 shall be three years and six
months rather than three years; and
‘‘(2)(A) if the drug is the subject of—
‘‘(i) a listed patent for which a certification
has 
been 
submitted 
under 
section
505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) and for
which pediatric studies were submitted prior to
the expiration of the patent (including any pat-
ent extensions), or
‘‘(ii) a listed patent for which a certifi-
cation has been submitted under section
505(b)(2)(A)(iii) 
or 
section
505(j)(2)(A)(vii)(III),
the period during which an application may not be
approved 
under 
section 
505(c)(3) 
or 
section
505(j)(4)(B), shall be extended by a period of six
months after the date the patent expires (including
any patent extensions); or
‘‘(B) if the drug is the subject of a listed patent
for which a certification has been submitted under
section 
505(b)(2)(A)(iv) 
or 
section
505(j)(2)(A)(vii)(IV), and in the patent infringement
litigation resulting from the certification the court
determines that the patent is valid and would be in-
fringed, the period during which an application may
not be approved under section 505(c)(3) or section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions).
‘‘(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR
WHICH ADDITIONAL PEDIATRIC INFORMATION MAY BE
BENEFICIAL.—Not later than 180 days after the date of
enactment of this section, the Secretary, after consultation
with experts in pediatric research (such as the American
Academy of Pediatrics, the Pediatric Pharmacology Re-
search Unit Network, and the United States Pharma-
copoeia) shall develop and publish an initial list of ap-
proved drugs for which additional pediatric information
may produce health benefits in the pediatric population.
The Secretary shall annually update the list.
‘‘(c) MARKET EXCLUSIVITY
FOR ALREADY-MAR-
KETED DRUGS.—If the Secretary makes a written request
for pediatric studies (which may include a time frame for
completing such studies) concerning a drug identified in
the list described in subsection (b) to the holder of an ap-
proved application under section 505(b)(1) for the drug,
the holder agrees to the request, and the studies are com-
pleted within any such time frame and the reports thereof
approved 
under 
section 
505(c)(3) 
or 
section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions); or
‘‘(B) if the drug is the subject of a listed patent
for which a certification has been submitted under
section 
505(b)(2)(A)(iv) 
or 
section
505(j)(2)(A)(vii)(IV), and in the patent infringement
litigation resulting from the certification the court
determines that the patent is valid and would be in-
fringed, the period during which an application may
not be approved under section 505(c)(3) or section
505(j)(4)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions).
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.—
‘‘(1) AGREEMENT
FOR
STUDIES.—The Sec-
retary may, pursuant to the written request for
studies, after consultation with
‘‘(A) the sponsor of an application for an
investigational new drug under section 505(i),
‘‘(B) the sponsor of an application for a
drug under section 505(b)(1), or
‘‘(C) the holder of an approved application
for a drug under section 505(b)(1), agree with
the sponsor or holder for the conduct of pedi-
atric studies for such drug.
‘‘(2) WRITTEN
PROTOCOLS
TO
MEET
THE
STUDIES REQUIREMENT.—If the sponsor or holder
and the Secretary agree upon written protocols for
such studies, the studies requirement of subsection
(a) or (c) is satisfied upon the completion of the
studies and submission of the reports thereof in ac-
cordance with the original written request and the
written agreement referred to in (1). Not later than
60 days after the submission of the report of the
studies, the Secretary shall determine if such studies
were or were not conducted in accordance with the
original written request and the written agreement
and reported in accordance with the requirements of
the Secretary for filing and so notify the sponsor or
holder.
‘‘(3) OTHER METHODS TO MEET THE STUDIES
REQUIREMENT.—If the sponsor or holder and the
Secretary have not agreed in writing on the proto-
cols for the studies, the studies requirement of sub-
section (a) or (c) is satisfied when such studies have
been completed and the reports accepted by the Sec-
retary. Not later than 90 days after the submission
of the reports of the studies, the Secretary shall ac-
cept or reject such reports and so notify the sponsor
or holder. The Secretary’s only responsibility in ac-
cepting or rejecting the reports shall be to deter-
mine, within 90 days, whether the studies fairly re-
spond to the written request, whether such studies
have been conducted in accordance with commonly
accepted scientific principles and protocols, and
whether such studies have been reported in accord-
ance with the requirements of the Secretary for fil-
ing.
‘‘(e) DELAY OF EFFECTIVE DATE FOR CERTAIN AP-
PLICATIONS; PERIOD OF MARKET EXCLUSIVITY.—If the
Secretary determines that the acceptance or approval of
an application under section 505(b)(2) or 505(j) for a
drug may occur after submission of reports of pediatric
studies under this section, which were submitted prior to
the expiration of the patent (including any patent exten-
sion) or market exclusivity protection, but before the Sec-
retary has determined whether the requirements of sub-
section (d) have been satisfied, the Secretary shall delay
the acceptance or approval under section 505(b)(2) or
505(j), respectively, until the determination under sub-
section (d) is made, but such delay shall not exceed 90
days. In the event that requirements of this section are
satisfied, the applicable period of market exclusivity re-
ferred to in subsection (a) or (c) shall be deemed to have
been running during the period of delay.
‘‘(f) NOTICE OF DETERMINATIONS ON STUDIES RE-
QUIREMENT.—The Secretary shall publish notice of any
determination that the requirements of subsection (d)
have been met and that submissions and approvals under
section 505(b)(2) or (j) for a drug will be subject to the
provisions of this section.
‘‘(g) 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
which a drug is anticipated to be used.
‘‘(h) LIMITATION.—The holder of an approved appli-
cation for a new drug that has already received six months
of market exclusivity under subsection (a) or subsection
(c) may, if otherwise eligible, obtain six months of market
exclusivity under subsection (c)(1)(B) for a supplemental
application; however the holder is not eligible for exclusiv-
ity under subsection (c)(2).
‘‘(i) SUNSET.—No period of market exclusivity shall
be granted under this section based on studies commenced
after January 1, 2004. The Secretary shall conduct a
study and report to Congress not later than January 1,
2003 based on the experience under the program. The
study and report shall examine all relevant issues, includ-
ing—
‘‘(1) the effectiveness of the program in improv-
ing information about important pediatric uses for
approved drugs;
‘‘(2) the adequacy of the incentive provided
under this section;
‘‘(3) the economic impact of the program; and
‘‘(4) any suggestions for modification that the
Secretary deems appropriate.’’.
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