[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2298 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 2298

           To improve the regulation of radiopharmaceuticals.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 30, 1997

 Mr. Coburn (for himself, Mr. Burr of North Carolina, Mr. Stupak, Ms. 
  DeGette, and Mr. Deutsch) introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
           To improve the regulation of radiopharmaceuticals.

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

SECTION. 1. REQUIREMENTS FOR RADIO- PHARMACEUTICALS.

    (a) Requirements.--
            (1) Regulations.--
                    (A) Proposed regulations.--Not later than 180 days 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services, after consultation with 
                patient advocacy groups, associations, physicians 
                licensed to use radiopharmaceuticals, and the regulated 
                industry, shall issue proposed regulations governing 
                the approval of radiopharmaceuticals designed for 
                diagnosis and monitoring of diseases and conditions. 
                The regulations shall provide that the determination of 
                the safety and effectiveness of such a 
                radiopharmaceutical under section 505 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 
                351 of the Public Health Service Act (42 U.S.C. 262) 
                shall include (but not be limited to) consideration of 
                the proposed use of the radiopharmaceutical in the 
                practice of medicine, the pharmacological and 
                toxicological activity of the radiopharmaceutical 
                (including any carrier or ligand component of the 
                radiopharmaceutical), and the estimated absorbed 
                radiation dose of the radiopharmaceutical.
                    (B) Final regulations.--Not later than 18 months 
                after the date of enactment of this Act, the Secretary 
                shall promulgate final regulations governing the 
                approval of the radiopharmaceuticals.
            (2) Special rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic or monitoring purposes, the 
        indications for which such radiopharmaceutical is approved for 
        marketing may, in appropriate cases, refer to manifestations of 
        disease (such as biochemical, physiological, anatomic, or 
        pathological processes) common to, or present in, 1 or more 
        disease states.
    (b) Definition.--In this section, the term ``radiopharmaceutical'' 
means--
            (1) an article--
                    (A) that is intended for use in the diagnosis or 
                monitoring of a disease or a manifestation of a disease 
                in humans; and
                    (B) that exhibits spontaneous disintegration of 
                unstable nuclei with the emission of nuclear particles 
                or photons; or
            (2) any nonradioactive reagent kit or nuclide generator 
        that is intended to be used in the preparation of any such 
        article.
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