[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3065 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3065

To amend the Federal Food, Drug, and Cosmetic Act to revise the review 
         of radiopharmaceuticals under section 505 of such Act.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 12, 1996

   Mr. Coburn (for himself, Mr. Burr, Mr. Stupak, and Mrs. Lincoln) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to revise the review 
         of radiopharmaceuticals under section 505 of such Act.

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

SECTION 1. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This Act may be cited as the 
``Radiopharmaceutical Review Improvement Act of 1996''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et 
seq.)

SEC. 2. REVIEW OF RADIOPHARMACEUTICALS.

    (a) Sec. 505.--Section 505 (21 U.S.C. 355) is amended by adding the 
following new subsection at the end thereof:
    ``(n)(1) For purposes of this section, the safety and effectiveness 
of a radiopharmaceutical are to be determined--
            ``(A) weighing the probable benefit to health from the use 
        of the radiopharmaceutical against any probable risk of injury 
        or illness from such use;
            ``(B) taking into account the absence or presence of 
        pharmacological and toxicological activity of the 
        radiopharmaceutical and the estimated absorbed dose of the 
        radiopharmaceutical.
    ``(2) In the case of a radiopharmaceutical intended to be used for 
diagnostic purposes, the indications for which such a 
radiopharmaceutical is approved under this section may refer to 
processes (such as biochemical, physiological, anatomical, or 
pathological), processes common to or present in one or more disease 
states, or may refer to a diagnostic procedure used in the diagnosis of 
one or more diseases.
    ``(3) As used in this subsection and section 503, the term 
`radiopharmaceutical' means--
            ``(A) an article that is intended for use in vivo in the 
        diagnosis, cure, mitigation, treatment, or prevention of 
        disease or a manifestation of disease in men, and that exerts 
        its primary effect by the spontaneous disintegration of 
        unstable nuclei with the emission of ionizing radiation; or
            ``(B) a reagent kit or nuclide generator that is intended 
        to be used in the preparation of any such article.''.
    (b) Sec. 503.--Section 503(g)(1) (21 U.S.C. 353(g)(1)) is amended--
            (1) in subparagraph (B), by striking ``or'';
            (2) in subparagraph (C), by striking the period and 
        inserting ``; or''; and
            (3) by inserting after subparagraph (C) the following new 
        subparagraph:
                    ``(D) a radiopharmaceutical, the persons charged 
                with premarket review of the radiopharmaceutical 
                products shall have primary jurisdiction.''.
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