title: Radiopharmaceutical regulation and Food and Drug Administration policy.
abstract: The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United States Pharmacopeia write radiopharmaceutical review standards, that an independent scientific body review the data submitted, and that the FDA either accept or reject the recommendation.
authors.affiliation: Department of Nuclear Medicine, National Institutes of Health, Bethesda, MD 20892-1180, USA.
authors.forename: M
authors.initials: M
authors.lastname: Rotman
authors.forename: D
authors.initials: D
authors.lastname: Laven
authors.forename: G
authors.initials: G
authors.lastname: Levine
mesh_terms: D006801:Humans; D007880:Legislation, Drug; D011786:Quality Control; D011868:Radioisotopes / Q000592:standards* / Q000627:therapeutic use; D014055:Tomography, Emission-Computed; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011868:Radioisotopes