REQUIREMENTS FOR RADIOPHARMACEUTICALS.

SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS. (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. 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 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, 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, one 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.