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FDA RADIATION THERAPY DEVICE FIRM INSPECTION PROGRAM

This article was originally published in The Gray Sheet

Executive Summary

FDA RADIATION THERAPY DEVICE FIRM INSPECTION PROGRAM will be among the topics addressed at a hearing of Sen. John Glenn's (D-Ohio) Government Affairs Committee scheduled for April 22. The committee will look into whether FDA is meeting its statutory two-year inspection schedule, particularly for firms that manufacture radiation therapy devices. Preliminary data provided to the panel by FDA indicates that FDA is behind schedule in inspection duties, according to committee staffers. The Glenn hearing was prompted by recent incidents of radiation overdose by Omnitron's Model 2000 high dose rate afterloader and by reports of unresolved safety risks from cobalt therapy devices. The Nuclear Regulatory Commission and FDA have been investigating overdose cases, including one leading to a patient death, that involved treatment with Omnitron's cancer therapy device at clinics in Pennsylvania ("The Gray Sheet" Feb. 15, p. 5). The NRC suspended one clinic's operating license in January, and an FDA inspection of Omnitron's manufacturing facility revealed violations of good manufacturing practices (GMP) regulations. Sen. Glenn also has been investigating potential problems with linear accelerators. Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce oversight subcommittee, highlighted safety problems with Theratronic's Theraplan cancer therapy and Therac 20 and Therac 25 linear accelerators at a hearing in March 1992 ("The Gray Sheet" March 30, 1992, p. 9). Officials from NRC and FDA are expected to be the lead witnesses at the hearing; testimony also may be provided by the Health Resources Services Administration, which is involved in regulation of radiation therapy technicians. The National Electrical Manufacturers Association, whose members include radiation therapy manufacturers, also is likely to be invited, according to committee staffers. Several medical professionals' associations and individual manufacturers may also be called to testify. The committee's hearing likely will focus primarily on NRC's radiation therapy regulatory responsibilities, staffers indicate. One area the committee will examine is the extent of coordination or overlap between FDA and NRC regulation of radiation therapy, with an eye towards possible consolidation in one agency. The NRC has direct authority over radiation therapy clinics. However, its investigation of the Omnitron situation included inspection of the firm's manufacturing facility, and an NRC investigators' report on Omnitron made reference to design flaws in the Model 2000 device. FDA's responsibilities for regulation of radiation- emitting device firms include conducting inspections for compliance with GMP and incident reporting regulations.
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