[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 2010 Introduced in Senate (IS)]

103d CONGRESS
  2d Session
                                S. 2010

    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 SENATE OF THE UNITED STATES

               April 12 (legislative day, April 11), 1994

   Mrs. Kassebaum (for herself, Mr. Dodd, Mr. Hatch, and Mr. Simon) 
introduced the following bill; which was read twice and referred to the 
                 Committee on Labor and Human Resources

_______________________________________________________________________

                                 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 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 pediatric 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 requirements 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 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 be 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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