Von Eschenbach Questioned on Banned Devices, Resources

FDA Commissioner Andrew von Eschenbach faced congressional questions about the agency’s failure to enforce its ban on the import of the Electro Physiological Feedback Xrroid (EPFX), a dubious medical device.

At a Jan. 29 hearing of the House Energy and Commerce Committee, Rep. Jay Inslee (D-Wash.) expressed concern about the continued sale of the EPFX in the U.S. and the alleged misuse of institutional review board clinical trial approval to market the device. EPFX manufacturer William Nelson fled the U.S. for Budapest, Hungary, in 1996 after he was indicted on felony fraud charges related to his marketing of the device.

Citing reports in The Seattle Times, Inslee said Nelson has managed to sell 10,000 of the devices in the U.S. from his Hungarian exile, and cancer patients who avoided standard medical treatment in favor of the EPFX have died as a result. The FDA has ruled that the devices can be seized at the U.S. border, but Inslee expressed concern that some of them are getting through anyway.

At the January hearing, former FDA Chief Counsel Peter Barton Hutt said insufficient FDA funding is contributing to difficulties stopping the sale of banned devices.

“The problem is with the FDA’s enforcement resources. We can’t cut back those resources and expect [the agency] will solve the kinds of problems you’re talking about. The FDA’s budget should be doubled over the next two years,” Hutt said.