Antiprogestin Testing Act of 1993

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).

Summary: Antiprogestin Testing Act of 1993 - Directs the Commissioner of Food and Drugs to collect: (1) information concerning the drug RU-486, including samples and specimens, required to be submitted by an applicant for approval of a new drug. And (2) such information regarding use of the drug as an abortifacient or contraceptive and for the treatment of cancer, brain tumors, Cushings syndrome, or other serious or life-threatening diseases. Requires the Commissioner to: (1) consider such information to be an application submitted by the manufacturer of the drug for its approval for each of such uses. And (2) review such information and issue an order approving or refusing to approve the application with respect to each such use. Directs the Commissioner to: (1) notify the Director of the National Institutes of Health (NIH) if the Commissioner issues an order refusing to approve the application because of the lack of adequate tests in the investigation of the drug, sufficient information, or substantial evidence. (2) submit to the Director all information relevant to the decision to issue such order. And (3) report to specified congressional committees concerning any such order. Requires the Director, if the Commissioner issues an order refusing to approve the application, to expeditiously conduct or support research on RU-486 in order to conduct tests that were not included in the investigation or to develop information or evidence that was not submitted with the application. Makes any such research subject to provisions of the Public Health Service Act concerning institutional review boards and peer review. Requires the Director to submit the results of the research to the Commissioner who shall consider the results to be information submitted by the drug manufacturer, review the drug application, and issue an order approving or refusing to approve it. Sets forth reporting requirements. Specifies that if the Commissioner issues an order approving an application with respect to such drug for any of such uses, any person who introduces the drug into interstate commerce or delivers the drug for such introduction shall reimburse the Food and Drug Administration and NIH for specified costs.