Medical Devices Put on Fast Track : Health: The FDA will speed up the evaluation process for technologies with lifesaving potential. Orange County manufacturers greet the news with cautious enthusiasm.

Medical devices with lifesaving potential will now receive top priority in the federal approval process, much as critically needed drugs have enjoyed in recent years, the Food and Drug Administration announced Thursday.

Under the new policy, breakthrough technological devices will no longer be evaluated on the same timetable as the thousands of other approval applications filed with the FDA each year, most of which are for products equivalent to others on the market and take more than a year to approve.

Instead, breakthrough devices will be given urgent consideration, a shift that FDA officials said could cut the approval time in half. The agency received 65 applications for such devices in 1992.

“We’re going to put them on a fast track,” Dr. Bruce Burlington, director of the FDA’s center for devices and radiological health, said in an interview. “The medically important devices will get through the system significantly faster. They are not going to get trapped in a bureaucratic queue.”

The news met with cautious enthusiasm in Orange County, which has more than 600 small medical-device manufacturers. Of those companies, about 80% are awaiting some kind of approval from the FDA.

“We applaud the FDA for finally coming to their senses and responding to a mounting avalanche of complaints,” said David Anast, publisher of Biomedical Market Newsletter in Costa Mesa. “It’s been a long time coming. But that (change) is just the tip of the iceberg of what needs to be reconciled at the FDA.”

The agency has been under attack by Congress and manufacturers of medical devices for the sluggish pace of approval of such items as a new heartbeat regulator, an artificial pancreas, an osteoporosis diagnostic machine and a device to help asthmatic children.

The pace of approvals for breakthrough medical devices has plummeted, from 56 approvals in 1989 to just 12 last year.

Critics say the slowdown not only leaves many gravely ill patients with few alternatives for treatment but also causes financial pain for medical-device makers, state and local governments.

“What this could mean is fewer layoffs and larger sales tax revenue,” Anast said of Thursday’s announcement by the FDA. “Some of these companies have been just hanging on.”

Earlier this month, Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, released a report criticizing the FDA for its failure to approve breakthrough devices more quickly and for laxity in reviewing other devices.

In a scathing rebuke of new, slower approval policies that followed the appointment of Dr. David A. Kessler in early 1991, Dingell wrote in a report: “If Dr. Kessler’s intent in adopting a new enforcement policy was to get the attention of the medical-device industry, he undoubtedly has achieved the desired effect. . . . The situation is intolerable.”

Answering those criticisms, the FDA’s Burlington said earlier this year that the agency was looking into several changes, one of which was the establishment of a fast track for breakthrough products.

He also has promised a database for improving communication between the agency and medical-device companies, and a more efficient way for federal reviewers and company researchers to decide how new devices should be studied before applications for approval are submitted to the FDA.

Burlington said the FDA will establish an expedited category to review new devices targeted for medical conditions where there now are no treatments and for products that show promise of providing a substantial advance over existing therapies.

“In those cases, we will deal with them first,” Burlington said. “It will be a modest number of products, but we will try to meet the public health need.”

The philosophy is the same as has been applied to the marketing of new drugs for AIDS, cancer and other diseases that are life-threatening or for which there are no alternative treatments.

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The FDA has shown a willingness in recent years to push such drugs through the process faster, both by being more flexible in evaluating research on the drugs and by increasing its post-market surveillance.

Reaction from the device industry ranged from optimism to disbelief.

“The fast-tracking of breakthrough products is a good idea, but it raises some concerns,” said an official with the Health Industry Manufacturers Assn., which represents many of the makers of medical devices.

Hany Hussein, president of Energy Life Systems Inc. in Costa Mesa, said he hopes that the new policy will help speed up the approval process for his company’s laser to halt the irregular heartbeat known as ventricular tachycardia. Such irregularity is a chief cause of sudden cardiac death, which kills about 400,000 Americans each year.

“It sounds nice,” Hussein said of the new policy, which he said should apply to his company. “It would be great if it could be done. It has been so uncertain for us.”

William Worthen, president of Neuro Navigational Corp., also in Costa Mesa, said his company has been financially damaged by delays. The company is developing products for vascular and neural surgery.

The new FDA procedure could definitely help his company, Worthen said, but “I’ll believe it when I see it.”

Some consumer organizations, however, have not supported speeding up the process, arguing that the FDA should resist industry pressures. The debate is being waged in the context of continuing concerns over failures of silicone gel breast implants and of Shiley heart valves, a small percentage of which developed cracks in metal struts holding them in place, causing the deaths of users.