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FDA IS LAX IN INSPECTING FACTORIES THAT MAKE MEDICAL GEAR, GAO SAYS

Congressional investigators said Wednesday the Food and Drug Administration is doing a poor job of inspecting factories that make medical devices and rarely takes action when it finds a problem.

A report by the General Accounting Office found that the FDA doesn't even know how many manufacturers it's supposed to be keeping track of. The agency estimates it is somewhere between 4,000 and 5,500.The FDA is supposed to inspect them every two years, but the GAO, the investigative arm of Congress, said fewer than 60 percent of the manufacturers get regular inspections on time.

More than half of those inspections found some kind of problem, but just 16 percent warranted some kind of action, the GAO said.

The FDA took action in half of the cases in which the most serious violations were found, the GAO said.

"What we have here is a sort of inverted pyramid," said Eleanor Chelimsky, assistant comptroller general who testified for the GAO.

The FDA is under pressure from the White House and others to speed up the process for approving new drugs and devices to get them into the hands of the sick and dying.

But the agency also must explain decisions that allowed certain drugs and devices to be sold, only to find out perhaps years later that there were serious problems or questions. In some cases it has cost people their lives.

A hearing Wednesday before the House Energy and Commerce subcommittee on oversight and investigations focused on two devices: a synthetic jelly used during eye surgery and a radiation treatment machine that malfunctioned and killed some cancer patients.

It was the first of a series of hearings on the subject.

The synthetic jelly, manufactured by Optical Radiation Corp., was to be injected into the eye to keep it stable during surgery.

"Practitioners began reporting adverse reactions, including incidence of blindness and loss of visual acuity, only a month after approval," according to a subcommittee document. "The adverse reactions reported to the agency now exceed 270."

The company withdrew the product from the market last fall.

The committee also was hearing of malfunctioning linear accelerators sold by Theratronics, which is owned by the Canadian government.

"Beginning in 1985, these malfunctions included crushing patients and exposing cancer patients to fatal doses of radiation in some cases, and in other cases, either over or under exposures occurred," the subcommittee document said.