I
103D CONGRESS
2D SESSION
H. R. 4427
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
MAY 16, 1994
Mr. KREIDLER (for himself, Mr. ROWLAND, Mrs. UNSOELD, and Mr. SWIFT)
introduced the following bill; which was referred to the Committee on En-
ergy and 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. 501 et seq.) is amended by inserting after
section 505 the following new section:
‘‘PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS
‘‘SEC. 505A. (a) If an application submitted under
section 505(b)(1) is approved on or after the date of en-
actment of this section, and such application includes re-
ports of pediatric studies described and requested in sub-
section (c), and such studies are completed and the reports
thereof submitted in accordance with subsection (c)(2) or
completed and the reports thereof accepted in accordance
with subsection (c)(3), the Secretary may not make the
approval of an application submitted under section
505(b)(2) or section 505(j) which refers to the drug for
which the section 505(b)(1) approval is granted effective
prior to the expiration of 6 months from the earliest date
on which the approval of such application for the drug
under section 505(b)(2) or section 505(j), respectively,
could otherwise be made effective under the applicable
provisions of this chapter.
‘‘(b) If the Secretary makes a written request for pe-
diatric studies described in subsection (c) to the holder
of an approval under section 505(b)(1) for a drug, and
such studies are completed and the reports thereof submit-
ted in accordance with subsection (c)(2) or completed and
the reports thereof accepted in accordance with subsection
(c)(3), the Secretary may not make the approval of an
application submitted under section 505(b)(2) or section
505(j) which refers to the drug subject to the section
505(b)(1) approval effective prior to the expiration of 6
months from the earliest date on which an approval of
such application under section 505(b)(2) or section 505(j),
respectively, could otherwise be made effective under the
applicable provisions of this chapter. Nothing in this sub-
section shall affect the ability of the Secretary to make
effective a section 505(b)(2) or section 505(j) approval for
a subject drug if such approval is proper under such sub-
section and is made effective prior to the submission of
the reports of pediatric studies described in subsection (c).
‘‘(c)(1) The Secretary may, pursuant to a written re-
quest for studies after consultation with the sponsor of
an application or holder of an approval for a drug under
section 505(b)(1), agree with the sponsor or holder for the
conduct of pediatric studies for such drug.
‘‘(2) If the sponsor or holder and the Secretary agree
upon written protocols for such studies, the studies re-
quirement of subsection (a) or (b) is satisfied upon the
completion of the studies in accordance with the protocols
and the submission of the reports thereof to the Secretary.
Within 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 written pro-
tocols and reported in accordance with the Secretary’s re-
quirements for filing and so notify the sponsor or holder.
‘‘(3) If the sponsor or holder and the Secretary have
not agreed in writing on the protocols for the studies, the
studies requirement of subsection (a) or (b) is satisfied
when such studies have been completed and the reports
accepted by the Secretary. Within 90 days after the sub-
mission 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 90
days, that the studies fairly respond to the written re-
quest, that such studies have been conducted in accord-
ance with commonly accepted scientific principles and pro-
tocols, and that such studies have been reported in accord-
ance with the Secretary’s requirements for filing.
‘‘(4) As used in this section, ‘pediatric studies’ or
‘studies’ means at least 1 human clinical investigation in
a population of adolescent age or younger. At the Sec-
retary’s discretion, pharmacokinetic studies may be con-
sidered as clinical investigations.
‘‘(d) If the Secretary determines that an approval of
an application under section 505(b)(2) or section 505(j)
for a drug may be made effective after submission of re-
ports of pediatric studies under this section but before the
Secretary has determined whether the requirements of
subsection (c) have been satisfied, the Secretary may delay
the effective date of any approval under section 505(b)(2)
or section 505(j), respectively, until the determination
under subsection (c) is made, but such delay shall not ex-
ceed 90 days. In the event that the requirements of this
section are satisfied, the 6-month period referred to in
subsection (a) or (b) shall be deemed to have begun on
the date an approval of an application under section
505(b)(2) or section 505(j), respectively, would have been
permitted absent action under this subsection.
‘‘(e) The Secretary shall publish notice of any deter-
mination that the requirements of subsection (c)(2) or
(c)(3) have been met and that approvals for the drug will
be subject to deferred effective dates under this section.’’.
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