II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Better Pharma5 ceuticals for Children Act’’.
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1 SEC. 2. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

2 Chapter V of the Federal Food, Drug, and Cosmetic

3 Act (21 U.S.C. 501 et seq.) is amended by inserting after

4 section 505 the following new section:

5 ‘‘PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS

6 ‘‘SEC. 505A. (a) If an application submitted under

7 section 505(b)(1) is approved on or after the date of en8 actment of this section, and such application includes re9 ports of pediatric studies described and requested in sub10 section (c), and such studies are completed and the reports

11 thereof submitted in accordance with subsection (c)(2) or

12 completed and the reports thereof accepted in accordance

13 with subsection (c)(3), the Secretary may not make the

14 approval of an application submitted under section

15 505(b)(2) or section 505(j) which refers to the drug for

16 which the section 505(b)(1) approval is granted effective

17 prior to the expiration of 6 months from the earliest date

18 on which the approval of such application for the drug

19 under section 505(b)(2) or section 505(j), respectively,

20 could otherwise be made effective under the applicable

21 provisions of this chapter.

22 ‘‘(b) If the Secretary makes a written request for pe23 diatric studies described in subsection (c) to the holder

24 of an approval under section 505(b)(1) for a drug, and

25 such studies are completed and the reports thereof submit26 ted in accordance with subsection (c)(2) or completed and
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1 the reports thereof accepted in accordance with subsection

2 (c)(3), the Secretary may not make the approval of an

3 application submitted under section 505(b)(2) or section

4 505(j) which refers to the drug subject to the section

5 505(b)(1) approval effective prior to the expiration of 6

6 months from the earliest date on which an approval of

7 such application under section 505(b)(2) or section 505(j),

8 respectively, could otherwise be made effective under the

9 applicable provisions of this chapter. Nothing in this sub10 section shall affect the ability of the Secretary to make

11 effective a section 505(b)(2) or section 505(j) approval for

12 a subject drug if such approval is proper under such sub13 section and is made effective prior to the submission of

14 the reports of pediatric studies described in subsection (c).

15 ‘‘(c)(1) The Secretary may, pursuant to a written re16 quest for studies after consultation with the sponsor of

17 an application or holder of an approval for a drug under

18 section 505(b)(1), agree with the sponsor or holder for the

19 conduct of pediatric studies for such drug.

20 ‘‘(2) If the sponsor or holder and the Secretary agree

21 upon written protocols for such studies, the studies re22 quirement of subsection (a) or (b) is satisfied upon the

23 completion of the studies in accordance with the protocols

24 and the submission of the reports thereof to the Secretary.

25 Within 60 days after the submission of the report of the
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1 studies, the Secretary shall determine if such studies were

2 or were not conducted in accordance with the written pro3 tocols and reported in accordance with the Secretary’s re4 quirements for filing and so notify the sponsor or holder.

5 ‘‘(3) If the sponsor or holder and the Secretary have

6 not agreed in writing on the protocols for the studies, the

7 studies requirement of subsection (a) or (b) is satisfied

8 when such studies have been completed and the reports

9 accepted by the Secretary. Within 90 days after the sub10 mission of the reports of the studies, the Secretary shall

11 accept or reject such reports and so notify the sponsor

12 or holder. The Secretary’s only responsibility in accepting

13 or rejecting the reports shall be to determine, within 90

14 days, that the studies fairly respond to the written re15 quest, that such studies have been conducted in accord16 ance with commonly accepted scientific principles and pro17 tocols, and that such studies have been reported in accord18 ance with the Secretary’s requirements for filing.

19 ‘‘(4) As used in this section, ‘pediatric studies’ or

20 ‘studies’ means at least 1 human clinical investigation in

21 a population of adolescent age or younger. At the Sec22 retary’s discretion, pharmacokinetic studies may be con23 sidered as clinical investigations.

24 ‘‘(d) If the Secretary determines that an approval of

25 an application under section 505(b)(2) or section 505(j)
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1 for a drug may be made effective after submission of re2 ports of pediatric studies under this section but before the

3 Secretary has determined whether the requirements of

4 subsection (c) have been satisfied, the Secretary may delay

5 the effective date of any approval under section 505(b)(2)

6 or section 505(j), respectively, until the determination

7 under subsection (c) is made, but such delay shall not ex8 ceed 90 days. In the event that the requirements of this

9 section are satisfied, the 6-month period referred to in

10 subsection (a) or (b) shall be deemed to have begun on

11 the date an approval of an application under section

12 505(b)(2) or section 505(j), respectively, would have been

13 permitted absent action under this subsection.

14 ‘‘(e) The Secretary shall publish notice of any deter15 mination that the requirements of subsection (c)(2) or

16 (c)(3) have been met and that approvals for the drug will

17 be subject to deferred effective dates under this section.’’.

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