[Congressional Record Volume 140, Number 38 (Tuesday, April 12, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: April 12, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mrs. KASSEBAUM (for herself, Mr. Dodd, Mr. Hatch, and Mr.
Simon):
S. 2010. 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; to
the Committee on Labor and Human Resources.
better pharmaceuticals for children act
Mrs. KASSEBAUM. Mr. President, today, together with Senators Dodd,
Hatch, and Simon, I am introducing the Better Pharmaceuticals for
Children Act. This legislation provides a strong incentive for
pharmaceutical companies to conduct pediatric trials for drugs which
are developed primarily for adults. It establishes a 6-month market
exclusivity for pharmaceuticals for which pediatric studies are
conducted at the request of the Secretary of Health and Human Services.
This incentive to conduct pediatric studies is sorely needed.
Currently, fewer than 30 percent of the prescription medications on the
U.S. market are approved for use by pediatric populations and labeled
for pediatric use. Pediatricians using drugs developed with adults in
mind but which may also be effective in children or be the only option
for treating the same diseases or illnesses in children must estimate
dosages from dosages found safe and effective in adults. Such estimates
are uncertain because children, and particularly those under 2 years of
age, often metabolize drugs differently than do adults. Further, some
drugs can be less safe in children than in adults even when appropriate
doses are used.
For these reasons, pediatricians have long had an active interest in
promoting clinical trials of drugs in infants and children so that the
drugs can be labeled for use by these age groups. However, there is
little incentive for drug sponsors to voluntarily perform studies for
medications which they intend to market for adults and whose use in
treating children is expected to generate little additional revenue.
Such studies would place a significant additional burden on an already
costly and lengthy research, development, and approval process.
I urge my colleagues to cosponsor the Better Pharmaceuticals for
Children Act.
Mr. President, I ask for unanimous consent that the text of the bill
appear in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2010
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Better Pharmaceuticals 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 enactment of
this section, and such application includes reports of
pediatric studies described and requested in subsection (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
pediatric 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 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 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 subsection 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 subsection 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 request
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 pediatrics studies for such drug.
``(2) If the sponsor or holder and the Secretary agree upon
written protocols for such studies, the studies requirement
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 protocols and
reported in accordance with the Secretary's requirement for
filing and so notify the sponsor or holder.
``(3) If the sponsor or holder 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
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 90 days,
that the studies fairly respond to the written request, that
such studies have been conducted in accordance with commonly
accepted scientific principles and protocols, and that such
studies have been reported in accordance 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 Secretary's
discretion, pharmacokinetic studies may considered 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 reports 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 exceed 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
determination 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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