The Food and Drug Administration, at the urging of Reagan administration budget officials, shelved a proposed regulation that would require manufacturers to report any deaths or injuries caused by faulty medical devices, a House subcommittee charged yesterday.
In a hearing on a 1976 law that directed the FDA to regulate thousands of medical devices from tampons to pacemakers, members of the House Commerce investigations subcommittee said the agency has done little to protect the public from potentially hazardous devices.
Rep. Albert Gore Jr. (D-Tenn.) said the requirement that FDA be told of all injuries caused by medical devices, first proposed at the end of the Carter administration, was a classic case of a consumer measure "disappearing in a black hole of Reaganomics."
Gore produced a letter from the Office of Management and Budget that directed the FDA to pull back the regulation because it would be a burden to manufacturers and was "not clearly useful."
But FDA Commissioner Arthur Hull Hayes Jr. told the panel that "I and I alone made the decision that this regulation be put in abeyance." He said the regulation also would have required companies to submit a great deal of information that he considered unnecessary. "Cost-effectiveness is terribly important . . . . I did not make the decision in a posture of absolute subservience," Hayes said.
Hayes said the FDA still hasn't finished classifying medical devices in the three categories mandated by the 1976 law--those needing only general controls, those for which FDA is supposed to adopt specific performance standards, and those requiring prior approval before they can be marketed.
And he acknowledged that after six years the agency has not written a single performance standard for the more than 1,000 devices in the category that requires such standards. Hayes said the rulemaking process is too complex and that the agency is relying instead on voluntary standards set by industry, although he conceded these cannot be enforced.
The panel said that FDA also has been lax in granting premarket approval to more sophisticated devices, often simply accepting the manufacturer's word that its product is similar to devices already on the market.
In one case, the subcommittee said, the FDA failed to take any action against Baxter Travenol Laboratories of Illinois, even after the company acknowledged giving the agency false information.
In 1980, Travenol asked FDA's permission to market a pump cassette that would regulate the flow of intravenous fluids into a patient's body. But Travenol had not yet manufactured the device, the subcommittee said, so it altered a competitor's product and submitted a picture of that pump as its own.
Two hospital studies later found that the firm's device was leaking substantial amounts of fluid into the bloodstream of patients, even after the pump had been turned off.
Gore said that FDA has taken no disciplinary action against Travenol and still has not determined whether its pump device is safe. "You have information the company has lied to you, you have information that two hospitals found the device life-threatening, and you have done nothing about it--nothing," he told Hayes.
Hayes replied that the company's infraction was a minor one and that his researchers were still studying the device. A Travenol spokesman said the disputed photo was submitted inadvertently, but that the pump has been modified and is totally safe.
In another case, the subcommittee said that FDA failed to penalize Bausch and Lomb Co. for marketing a new bifocal contact lens without the agency's required permission. The firm ignored FDA's warnings by selling the lenses for six months before agreeing to withdraw them in January, the panel said.
Hayes said some of the regulatory delays would be eased when he merges FDA's Bureau of Medical Devices with another bureau on radiological health, a plan that subcommittee members greeted with skepticism.