Medical Manufacturers Given a Headache : Regulation: Former head of FDA unit that approves new devices warns of more red tape and delay, not less.

The former head of the Food and Drug Adminstration’s medical device regulatory division said Thursday that the industry should gird itself for even longer approval processes and stricter enforcement despite President Bush’s recent promise to cut red tape.

John C. Villforth, who retired from his FDA post in 1990, told a group of medical manufacturers and marketing experts that their dealings with the FDA could become even more adversarial than they have been in recent years.

It is a warning that has particularly chilling implications for Orange County’s burgeoning biomedical and health care industries because of the large number of small firms dependent on single products and unable to survive protracted FDA approval reviews.

“I suggest that if you don’t have someone in your organization who knows (about FDA regulations), then as manufacturers you better get help,” Villforth said. “Things are going to get worse, more complicated, more protracted.”

It can take 10 years or more for a new drug to be developed, tested and approved for general sale. Some industry experts say the long approval process already can make some medical devices obsolete before they can be marketed. A medical device is an implement, rather than a drug, used to treat patients. They include everything from surgical instruments and syringes to magnetic resonance imaging chambers.

Villforth, now president of the nonprofit Food & Drug Law Institute in Washington, said congressional hearings on the silicone breast implant controversy likely will cause the FDA to become stricter in its dealings with the drug and medical devices industry.

Although the FDA defends its regulatory practices--which some critics say are too lax--many industry insiders say the usually lengthy FDA approval process is getting longer as the process increasingly becomes weighed down with voluminous--and expensive--paperwork.

“Most of us are preparing ourselves for longer and more intense scrutinization,” said Kevin Keene, marketing manager for Beckman Instruments’ special chemistry products division in Brea.

David Anast, publisher of the Costa Mesa-based Biomedical Market Newsletter, said the blossoming biomedical industry in Orange County should heed Villforth’s bleak warning that it will take “a messiah” to change the growing adversarial relationship between the FDA and the industry.

“The medical companies have to wake up,” Anast said. “It is the new reality.”

Industry spokesmen increasingly complain that the approval process not only eats up research money but keeps vital medical equipment and drugs off the market and away from patients for too long.

Villforth made his remarks here in a speech at the Medical Marketing Assn.’s annual conference.

Seminars at the three-day conference tackle such topics as how to identify new, marketable medical products, product licensing and future trends in the health care industry.

“When I get through, many of you will be a little depressed,” Villforth told the audience of about 250 health care and biomedical representatives. The conference is titled “Growing Opportunities in a Shrinking World,” but the former FDA regulator said he was talking about “shrinking opportunities in a growing world.”

He said the medical industry should not expect any real changes in the approval process for drugs and devices and characterized the FDA as rife with morale problems, partly because of a push in recent years toward enforcement practices and away from medical device and drug approvals.

For example, the FDA seized Sporicidin International in December, ordering it to suspend manufacturing of its product line. The government claimed that many of the Rockville, Md., company’s products did not work.

But Villforth said such actions illuminate a growing adversarial relationship between the regulatory agency and the medical industry. Consequently, he said, many FDA reviewers are becoming disillusioned.

“The loss of morale is high, the turnover is increasing,” he said. “I’m worried that the increased emphasis on enforcement is not putting the necessary resources into the approval area.”