Lawmakers Urged to Prod FDA : Health: Manufacturers of medical devices meet with Feinstein and others to stress their need for speedier approval process.

More than 100 medical-device manufacturers converged in Washington on Thursday, meeting with Sen. Dianne Feinstein (D-Calif.) and other lawmakers in an effort to force changes in the U.S. Food and Drug Administration.

The series of daylong meetings on Capitol Hill was the latest round in a fight for what medical-device industry officials say are much-needed reforms at the Rockville, Md., agency.

Critics complain that the FDA--which is responsible for regulating and approving drugs, medical devices and food products--has in the past three years slowed down its approval process, leaving applications for hundreds of proposed medical devices to pile up on desks. As a result, some medical-device companies have been forced to lay off workers or ship manufacturing operations overseas, where approvals have come faster, critics say.

Only 12 breakthrough medical devices were approved last year for sale in the United States. That was down dramatically from 56 approvals in 1989. That slowdown, industry officials say, has had a profound effect on medical-device companies in Southern California, which has hundreds of small to mid-size firms--from makers of artificial pancreases for diabetics to heartbeat regulators and devices to unclog arteries.

Critics say that the slowdown is not only forcing up the cost of such devices but is also depriving thousands of patients of potentially lifesaving procedures.

The Thursday meetings with more than 300 lawmakers followed a scathing report by Rep. John D. Dingell (D-Mich.), released in May, that accused the FDA of “excessive delays and disorganization.”

“The industry is facing a number of very critical issues,” said Alan Magazine, president of the Health Industry Manufacturers Assn. in Washington, the industry lobby group that organized the sessions. “Our (association) staff can only carry the message so far.”

Feinstein aide William Chandler, who attended a meeting with 21 California executives, said the freshman senator had been only marginally aware of the industry’s concerns about the FDA.

“I think she found the meeting very informative because it raised some concerns in her mind about the degree of the problem,” Chandler said. “She is very eager to help.”

One immediate way she could do so, executives said Thursday, would be to look into a Senate bill that may soon be up for a floor vote. That bill would allow the FDA to levy so-called “user fees” that would be paid by medical-device manufacturers to help cover the costs of reviewing applications.

Feinstein is on a Senate subcommittee that is studying the user-fee bill. The bill, as it is written, would channel the fees toward reduction of the $309-billion budget deficit, even though FDA Commissioner David Kessler has defended user fees in the past by saying that the agency needs an additional $50 million a year to process the growing number of applications for medical-device approvals.

Device manufacturers who attended the Washington session with Feinstein said they would back the user fees, but only if the funds were used to hire more reviewers and improve the efficiency of the agency.

“What we want is to make sure that the FDA (approval) process is clear, predictable and timely,” said William Graham, vice president of Beckman Instruments Inc. in Fullerton, which makes laboratory diagnostic machines.

FDA spokeswoman Sharon Snider said, however, that the FDA, which has acknowledged a need for reform, has taken recent steps to speed up the approval process in its Center for Devices and Radiological Health, the division that oversees medical devices.

“I don’t know how they can say anything when we have a strong program just starting out,” Snider said.

The FDA “fast-track” plan, announced in late June, calls for reducing the time required to review and approve lifesaving devices and for giving timely reports to manufacturers on where their products are in the approval process.

Manufacturers say that until they see results, though, they will continue to be skeptical and will press for changes.

“I for one am on the warpath,” said William Crawford, a senior vice president for Interventional Technology Inc. in San Diego. “I am outraged by the lack of performance by a public agency. I demand better.”

Steven Ziemba, vice president of regulatory affairs for Staar Surgical Inc. in Monrovia, agreed.

“I think Dingell’s report has certainly raised the noise level,” he said. Feinstein “certainly spent a lot of time questioning us about the issue. I think she was quite receptive.”