[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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