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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 222 Introduced in Senate (IS)]

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.

    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 ``Antiprogestin Testing Act of 1993''.

SEC. 2. INFORMATION.

    (a) Collection.--
            (1) In general.--The Commissioner of Food and Drugs 
        (referred to in this section as the ``Commissioner'') shall, to 
        the extent possible, collect information with respect to the 
        drug RU-486, also known as Mifeprestone, including samples and 
        specimens, that is required to be submitted by an applicant for 
        approval of a new drug, as described in section 505(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).
            (2) Uses of drug.--The Commissioner shall collect such 
        information regarding--
                    (A) use of the drug as an abortifacient or 
                contraceptive; and
                    (B) use of the drug for the treatment of cancer, 
                brain tumors, Cushings syndrome, or other serious or 
                life-threatening diseases.
    (b) Consideration.--The Commissioner shall consider the information 
collected under subsection (a) with respect to the drug to be an 
application, submitted by the manufacturer of the drug, for approval of 
the drug for each of the uses described in subsection (a)(2).
    (c) Approval Decision.--
            (1) In general.--The Commissioner shall review the 
        information collected under subsection (a) as if the 
        information comprised such an application. The Commissioner 
        shall issue an order approving, or refusing to approve, the 
        application with respect to each of the uses in accordance with 
        subsections (c) and (d) of section 505 of such Act.
            (2) Refusal to approve due to insufficient tests, 
        information, or evidence.--
                    (A) Notification of director of national institutes 
                of health.--The Commissioner shall notify the Director 
                of the National Institutes of Health (referred to in 
                this section as the ``Director'') if the Commissioner 
                issues an order refusing to approve the application 
                because of--
                            (i) the lack of inclusion of adequate tests 
                        in the investigation of the drug, as described 
                        in section 505(d)(1) of such Act;
                            (ii) insufficient information, as described 
                        in section 505(d)(4) of such Act; or
                            (iii) a lack of substantial evidence, as 
                        described in section 505(d)(5) of such Act.
                    (B) Information.--On so notifying the Director, the 
                Commissioner shall submit to the Director all 
                information relevant to the decision of the 
                Commissioner to issue such order. Such information 
                shall include a description of the tests that were not 
                included in the investigation, or a description of the 
                information or evidence that was not submitted with the 
                application.
            (3) Report.--The Commissioner shall prepare, and submit to 
        the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Labor and Human Resources 
        of the Senate, a report concerning any order issued under 
        paragraph (1).
    (d) Research.--
            (1) In general.--If the Commissioner issues an order 
        refusing to approve the application, the Director shall 
        expeditiously conduct or support research (including clinical 
        trials) on RU-486, in order to conduct the tests, or develop 
        the information or evidence, described in subsection (c)(2)(B).
            (2) Institutional review boards and peer review.--Research 
        conducted or supported under paragraph (1) shall be subject to 
        sections 491 and 492 of the Public Health Service Act (42 
        U.S.C. 289 and 289a).
            (3) Results.--The Director shall submit the results of the 
        research to the Commissioner. The Commissioner shall consider 
        the results, along with the information collected under 
        subsection (a) with respect to the drug, to be information 
        submitted by the manufacturer of the drug as described in 
        subsection (b), and shall review, and issue an order approving 
        or refusing to approve, the application for the drug, in 
        accordance with subsection (c).
    (e) Report.--The Secretary of Health and Human Services shall 
prepare, and submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Labor and Human Resources 
of the Senate, a report on the status of research conducted or 
supported under subsection (d) within 6 months of the date on which the 
Commissioner provides notification under subsection (c)(2)(A), and 
every 6 months thereafter until the research is completed.

SEC. 3. FEES AND COSTS.

    If the Commissioner issues an order approving an application with 
respect to the drug RU-486 for a use described in section 2(a)(2), any 
person who introduces the drug into interstate commerce or delivers the 
drug for introduction into interstate commerce for such use shall 
reimburse--
            (1) the Food and Drug Administration for--
                    (A) the amount indicated in the fee schedule set 
                forth in section 736 of the Federal Food, Drug, and 
                Cosmetic Act; and
                    (B) the amount of the costs incurred by the 
                Commissioner in complying with section 2(a); and
            (2) the National Institutes of Health for the amount of any 
        costs incurred by the Director in complying with section 2(d).

                                 <all>
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