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OTC AIDS TESTS PUT ON FDA HOLD

Executive Summary

OTC AIDS TESTS PUT ON FDA HOLD: agency says it will only approve test kits for "professional use." In a March 30 letter from FDA Center for Biologics Evaluation and Research Director Paul Parkman, MD, to 17 manufacturers seeking approval of blood collection kits for at-home AIDS testing, FDA said kits "must be labeled and marketed for professional use only within a comprehensive health care environment (e.g., hospitals, medical clinics, doctor's offices, [sexually transmitted disease] clinics, alternate site test sites and mental health clinics." In addition, the kits "must provide for the collection of a venipuncture or other appropriately validated sample by one who is recognized by a state or local authority to perform such procedures." Since last summer, FDA has been trying to work out an approach to regulating the home kits as Class III devices, which would require premarket approval review. The Center for Biologics Evaluation and Research was given the responsibility for the premarket reviews for AIDS tests last July. FDA considered the recommendations of the Public Health Service's executive AIDS task force and other FDA topsiders in deciding to forego approval reviews for home-use tests. FDA's final decision reportedly takes into account the concerns of a number of government health officials about the misuse of test information and the possibility of inaccurate test results. The agency's reticence on AIDS home-use tests fits with a general approach to home test kits expressed recently by FDA Commissioner Young. At the February FDA/Proprietary Association meeting on self-medication, Young indicated that over-the-counter diagnostics should not be used as a substitute for a physician's diagnosis. FDA says that it is considering public workshops to collect more information on potential home-use of AIDS tests. A series of open public meetings may be announced in the Federal Register. FDA said it is holding open the possibility that the use of test kits approved according to the new criteria may be expanded to include home collection. FDA's move to defer review of home kits in the face of pending applications is a standard FDA procedure. Soliciting outside opinion buys FDA some time in deciding how to regulate AIDS testing. The agency reportedly has received some applications for at-home AIDS tests but found them not approvable. Companies seeking FDA approval include Discreet Medical Testing of Santa Ana, California, MikroMed of Tucson, Arizona and USAT Laboratories of Bakersfield, California. In August 1987, FDA halted the distribution of home collection kits by MikroMed, requesting that a premarket approval application be filed.
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