II

103D CONGRESS

1ST SESSION S. 222

To require the Commissioner of Food and Drugs to collect information regarding the drug RU–486 and review the information to determine whether

to approve RU–486 for marketing as a new drug, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 27 (legislative day, JANUARY 5), 1993

Mr. WELLSTONE introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

To require the Commissioner of Food and Drugs to collect

information regarding the drug RU–486 and review the

information to determine whether to approve RU–486

for marketing as a new drug, 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 ‘‘Antiprogestin Testing

5 Act of 1993’’.

6 SEC. 2. INFORMATION.

7 (a) COLLECTION.—
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1 (1) IN GENERAL.—The Commissioner of Food

2 and Drugs (referred to in this section as the ‘‘Com3 missioner’’) shall, to the extent possible, collect in4 formation with respect to the drug RU–486, also

5 known as Mifeprestone, including samples and speci6 mens, that is required to be submitted by an appli7 cant for approval of a new drug, as described in sec8 tion 505(b) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355(b)).

10 (2) USES OF DRUG.—The Commissioner shall

11 collect such information regarding—

12 (A) use of the drug as an abortifacient or

13 contraceptive; and

14 (B) use of the drug for the treatment of

15 cancer, brain tumors, Cushings syndrome, or

16 other serious or life-threatening diseases.

17 (b) CONSIDERATION.—The Commissioner shall con18 sider the information collected under subsection (a) with

19 respect to the drug to be an application, submitted by the

20 manufacturer of the drug, for approval of the drug for

21 each of the uses described in subsection (a)(2).

22 (c) APPROVAL DECISION.—

23 (1) IN GENERAL.—The Commissioner shall re24 view the information collected under subsection (a)

25 as if the information comprised such an application.
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1 The Commissioner shall issue an order approving, or

2 refusing to approve, the application with respect to

3 each of the uses in accordance with subsections (c)

4 and (d) of section 505 of such Act.

5 (2) REFUSAL TO APPROVE DUE TO INSUFFI6 CIENT TESTS, INFORMATION, OR EVIDENCE.—

7 (A) NOTIFICATION OF DIRECTOR OF NA8 TIONAL INSTITUTES OF HEALTH.—The Com9 missioner shall notify the Director of the Na10 tional Institutes of Health (referred to in this

11 section as the ‘‘Director’’) if the Commissioner

12 issues an order refusing to approve the applica13 tion because of—

14 (i) the lack of inclusion of adequate

15 tests in the investigation of the drug, as

16 described in section 505(d)(1) of such Act;

17 (ii) insufficient information, as de18 scribed in section 505(d)(4) of such Act; or

19 (iii) a lack of substantial evidence, as

20 described in section 505(d)(5) of such Act.

21 (B) INFORMATION.—On so notifying the

22 Director, the Commissioner shall submit to the

23 Director all information relevant to the decision

24 of the Commissioner to issue such order. Such

25 information shall include a description of the
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1 tests that were not included in the investiga2 tion, or a description of the information or evi3 dence that was not submitted with the applica4 tion.

5 (3) REPORT.—The Commissioner shall prepare,

6 and submit to the Committee on Energy and Com7 merce of the House of Representatives and the Com8 mittee on Labor and Human Resources of the Sen9 ate, a report concerning any order issued under

10 paragraph (1).

11 (d) RESEARCH.—

12 (1) IN GENERAL.—If the Commissioner issues

13 an order refusing to approve the application, the Di14 rector shall expeditiously conduct or support re15 search (including clinical trials) on RU–486, in

16 order to conduct the tests, or develop the informa17 tion or evidence, described in subsection (c)(2)(B).

18 (2) INSTITUTIONAL REVIEW BOARDS AND PEER

19 REVIEW.—Research conducted or supported under

20 paragraph (1) shall be subject to sections 491 and

21 492 of the Public Health Service Act (42 U.S.C. 289

22 and 289a).

23 (3) RESULTS.—The Director shall submit the

24 results of the research to the Commissioner. The

25 Commissioner shall consider the results, along with
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1 the information collected under subsection (a) with

2 respect to the drug, to be information submitted by

3 the manufacturer of the drug as described in sub4 section (b), and shall review, and issue an order ap5 proving or refusing to approve, the application for

6 the drug, in accordance with subsection (c).

7 (e) REPORT.—The Secretary of Health and Human

8 Services shall prepare, and submit to the Committee on

9 Energy and Commerce of the House of Representatives

10 and the Committee on Labor and Human Resources of

11 the Senate, a report on the status of research conducted

12 or supported under subsection (d) within 6 months of the

13 date on which the Commissioner provides notification

14 under subsection (c)(2)(A), and every 6 months thereafter

15 until the research is completed.

16 SEC. 3. FEES AND COSTS.

17 If the Commissioner issues an order approving an ap18 plication with respect to the drug RU–486 for a use de19 scribed in section 2(a)(2), any person who introduces the

20 drug into interstate commerce or delivers the drug for in21 troduction into interstate commerce for such use shall re22 imburse—

23 (1) the Food and Drug Administration for—
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1 (A) the amount indicated in the fee sched2 ule set forth in section 736 of the Federal

3 Food, Drug, and Cosmetic Act; and

4 (B) the amount of the costs incurred by

5 the Commissioner in complying with section

6 2(a); and

7 (2) the National Institutes of Health for the

8 amount of any costs incurred by the Director in

9 complying with section 2(d).

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