II

104TH CONGRESS

2D SESSION S. 2178

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

SEPTEMBER 30, 1996

Mrs. KASSEBAUM (for herself, Mr. KENNEDY, Mr. DODD, Mr. DEWINE, MS.

MIKULSKI, 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. 351 et seq.) is amended by inserting after

4 section 505 the following new section:

5 ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

6 ‘‘(a) MARKET EXCLUSIVITY FOR NEW DRUGS.—If,

7 prior to approval of an application that is submitted under

8 section 505(b)(1) the Secretary determines that informa9 tion relating to the use of a drug in the pediatric popu10 lation may produce health benefits in that population, the

11 Secretary makes a written request for pediatric studies

12 (which may include a time frame for completing such stud13 ies), and such studies are completed within any such time

14 frame and the reports thereof submitted in accordance

15 with subsection (d)(2) or completed within any such time

16 frame and the reports thereof are accepted in accordance

17 with subsection (d)(3)—

18 ‘‘(1)(A) the period during which an application

19 may not be submitted under subsections

20 (c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 shall be

21 five years and six months rather than five years, and

22 the references in subsections (c)(3)(D)(ii) and

23 (j)(4)(D)(ii) of section 505 to four years, to forty24 eight months, and to seven and one-half years shall

25 be deemed to be four and one-half years, fifty-four

26 months, and eight years, respectively; or
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1 ‘‘(B) the period of market exclusivity under

2 subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii)

3 and (iv) of section 505 shall be three years and six

4 months rather than three years; and

5 ‘‘(2)(A) if the drug is the subject of—

6 ‘‘(i) a listed patent for which a certification

7 has been submitted under section

8 505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) and for

9 which pediatric studies were submitted prior to

10 the expiration of the patent (including any pat11 ent extensions), or

12 ‘‘(ii) a listed patent for which a certifi13 cation has been submitted under section

14 505(b)(2)(A)(iii) or section

15 505(j)(2)(A)(vii)(III),

16 the period during which an application may not be

17 approved under section 505(c)(3) or section

18 505(j)(4)(B) shall be extended by a period of six

19 months after the date the patent expires (including

20 any patent extensions); or

21 ‘‘(B) if the drug is the subject of a listed patent

22 for which a certification has been submitted under

23 section 505(b)(2)(A)(iv) or section

24 505(j)(2)(A)(vii)(IV), and in the patent infringement

25 litigation resulting from the certification the court
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1 determines that the patent is valid and would be in2 fringed, the period during which an application may

3 not be approved under section 505(c)(3) or section

4 505(j)(4)(B) shall be extended by a period of six

5 months after the date the patent expires (including

6 any patent extensions).

7 ‘‘(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR

8 WHICH ADDITIONAL PEDIATRIC INFORMATION MAY BE

9 BENEFICIAL.—Not later than 180 days after the date of

10 enactment of this section, the Secretary, after consultation

11 with experts in pediatric research (such as the American

12 Academy of Pediatrics, the Pediatric Pharmacology Re13 search Unit Network, and the United States Pharma14 copoeia) shall develop and publish an initial list of ap15 proved drugs for which additional pediatric information

16 may produce health benefits in the pediatric population.

17 The Secretary shall annually update the list.

18 ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MAR19 KETED DRUGS.—If the Secretary makes a written request

20 for pediatric studies (which may include a time frame for

21 completing such studies) concerning a drug identified in

22 the list described in subsection (b) to the holder of an ap23 proved application under section 505(b)(1) for the drug,

24 the holder agrees to the request, and the studies are com25 pleted within any such time frame and the reports thereof
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1 submitted in accordance with subsection (d)(2) or com2 pleted within any such time frame and the reports thereof

3 accepted in accordance with subsection (d)(3)—

4 ‘‘(1)(A) the period during which an application

5 may not be submitted under subsections

6 (c)(3)(D)(ii) and (j)(4)(D)(ii) of section 505 shall be

7 five years and six months rather than five years, and

8 the references in subsections (c)(3)(D)(ii) and

9 (j)(4)(D)(ii) of section 505 to four years, to forty10 eight months, and to seven and one-half years shall

11 be deemed to be four and one-half years, fifty-four

12 months, and eight years, respectively; or

13 ‘‘(B) the period of market exclusivity under

14 subsections (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii)

15 and (iv) of section 505 shall be three years and six

16 months rather than three years; and

17 ‘‘(2)(A) if the drug is the subject of (i) a listed

18 patent for which a certification has been submitted

19 under section 505(b)(2)(A)(ii) or (j)(2)(A)(vii)(II)

20 and for which pediatric studies were submitted prior

21 to the expiration of the patent (including any patent

22 extensions), or (ii) a listed patent for which a certifi23 cation has been submitted under section

24 505(b)(2)(A)(iii) or section 505(j)(2)(A)(vii)(III),

25 the period during which an application may not be
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1 approved under section 505(c)(3) or section

2 505(j)(4)(B) shall be extended by a period of six

3 months after the date the patent expires (including

4 any patent extensions); or

5 ‘‘(B) if the drug is the subject of a listed patent

6 for which a certification has been submitted under

7 section 505(b)(2)(A)(iv) or section

8 505(j)(2)(A)(vii)(IV), and in the patent infringement

9 litigation resulting from the certification the court

10 determines that the patent is valid and would be in11 fringed, the period during which an application may

12 not be approved under section 505(c)(3) or section

13 505(j)(4)(B) shall be extended by a period of six

14 months after the date the patent expires (including

15 any patent extensions).

16 ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.—

17 ‘‘(1) AGREEMENT FOR STUDIES.—The Sec18 retary may, pursuant to the written request for

19 studies, after consultation with

20 ‘‘(A) the sponsor of an application for an

21 investigational new drug under section 505(i),

22 ‘‘(B) the sponsor of an application for a

23 drug under section 505(b)(1), or

24 ‘‘(C) the holder of an approved application

25 for a drug under section 505(b)(1), agree with
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1 the sponsor or holder for the conduct of pedi2 atric studies for such drug.

3 ‘‘(2) WRITTEN PROTOCOLS TO MEET THE

4 STUDIES REQUIREMENT.—If the sponsor or holder

5 and the Secretary agree upon written protocols for

6 such studies, the studies requirement of subsection

7 (a) or (c) is satisfied upon the completion of the

8 studies and submission of the reports thereof in ac9 cordance with the original written request and the

10 written agreement referred to in (1). Not later than

11 60 days after the submission of the report of the

12 studies, the Secretary shall determine if such studies

13 were or were not conducted in accordance with the

14 original written request and the written agreement

15 and reported in accordance with the requirements of

16 the Secretary for filing and so notify the sponsor or

17 holder.

18 ‘‘(3) OTHER METHODS TO MEET THE STUDIES

19 REQUIREMENT.—If the sponsor or holder and the

20 Secretary have not agreed in writing on the proto21 cols for the studies, the studies requirement of sub22 section (a) or (c) is satisfied when such studies have

23 been completed and the reports accepted by the Sec24 retary. Not later than 90 days after the submission

25 of the reports of the studies, the Secretary shall ac-
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1 cept or reject such reports and so notify the sponsor

2 or holder. The Secretary’s only responsibility in ac3 cepting or rejecting the reports shall be to deter4 mine, within 90 days, whether the studies fairly re5 spond to the written request, whether such studies

6 have been conducted in accordance with commonly

7 accepted scientific principles and protocols, and

8 whether such studies have been reported in accord9 ance with the requirements of the Secretary for fil10 ing.

11 ‘‘(e) DELAY OF EFFECTIVE DATE FOR CERTAIN AP12 PLICATIONS; PERIOD OF MARKET EXCLUSIVITY.—If the

13 Secretary determines that the acceptance or approval of

14 an application under section 505(b)(2) or 505(j) for a

15 drug may occur after submission of reports of pediatric

16 studies under this section, which were submitted prior to

17 the expiration of the patent (including any patent exten18 sion) or market exclusivity protection, but before the Sec19 retary has determined whether the requirements of sub20 section (d) have been satisfied, the Secretary shall delay

21 the acceptance or approval under section 505(b)(2) or

22 505(j), respectively, until the determination under sub23 section (d) is made, but such delay shall not exceed 90

24 days. In the event that requirements of this section are

25 satisfied, the applicable period of market exclusivity re-
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1 ferred to in subsection (a) or (c) shall be deemed to have

2 been running during the period of delay.

3 ‘‘(f) NOTICE OF DETERMINATIONS ON STUDIES RE4 QUIREMENT.—The Secretary shall publish notice of any

5 determination that the requirements of subsection (d)

6 have been met and that submissions and approvals under

7 section 505(b)(2) or (j) for a drug will be subject to the

8 provisions of this section.

9 ‘‘(g) DEFINITIONS.—As used in this section, the term

10 ‘pediatric studies’ or ‘studies’ means at least one clinical

11 investigation (that, at the Secretary’s discretion, may in12 clude pharmacokinetic studies) in pediatric age-groups in

13 which a drug is anticipated to be used.

14 ‘‘(h) LIMITATION.—The holder of an approved appli15 cation for a new drug that has already received six months

16 of market exclusivity under subsection (a) or subsection

17 (c) may, if otherwise eligible, obtain six months of market

18 exclusivity under subsection (c)(1)(B) for a supplemental

19 application; however the holder is not eligible for exclusiv20 ity under subsection (c)(2).’’

21 ‘‘(i) SUNSET.—No period of market exclusivity shall

22 be granted under this section based on studies commenced

23 after January 1, 2004. The Secretary shall conduct a

24 study and report to Congress not later than January 1,

25 2003 based on the experience under the program. The
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1 study and report shall examine all relevant issues, includ2 ing—

3 ‘‘(1) the effectiveness of the program in improv4 ing information about important pediatric uses for

5 approved drugs;

6 ‘‘(2) the adequacy of the incentive provided

7 under this section;

8 ‘‘(3) the economic impact of the program; and

9 ‘‘(4) any suggestions for modification that the

10 Secretary deems appropriate.’’.

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