Manufacturers applaud quicker federal approvals.

Food and Drug Administration gets more efficient

During these first few weeks of 1996, Steven Ziemba has been marveling at the difference a year can make.

Ziemba is one of several Los Angeles-area medical manufacturers who are applauding the U.S. Food and Drug Administration for chopping approval times on routine applications by as much as two-thirds during the past year.

"It used to be you would submit something, and it would languish for months and months, and now the FDA is acting on it fairly quickly," said Ziemba, who is vice president of regulatory affairs for Monrovia-based Staar Surgical Co. "Files that used to take a year now will take three or four months."

Ziemba's job is to gain federal approval for Staar Surgical's new or improved medical devices. He oversees two dozen or more requests that Staar Surgical typically submits for approval to the FDA each year. As is typical in the medical device industry, nearly all of Staar Surgical's submissions are for what are termed 510(k) products. These range from minor design changes to more complicated modifications. New "breakthrough" devices undergo a more exhaustive type of review.

"For firms like us, (speedier review) makes a huge, huge difference," Ziemba said. "Any business runs on its ability to get to the market." Shorter approval times have enhanced Staar's competitiveness, he said.

Job security

Speedier approvals from the FDA also may help Staar to add or retain jobs in California - jobs that otherwise might have gone to Europe, where governments smile much more quickly on medical device applications than the FDA does.

Many U.S.-based manufacturers secure needed government approvals and introduce their new medical devices in Europe up to three years before they win permission to sell them in the United States.

Staar Surgical maintains a European presence, making products and conducting some clinical trials at a location near Geneva, Switzerland. The company had been thinking of moving more clinical trials to Europe, but has reconsidered because of the speedup in FDA approvals.

"It's allowed us to at least keep jobs here that otherwise would have gone to Europe," Ziemba said.

Staar employs in excess of 200 workers in Monrovia.

At MiniMed Technologies in Sylmar, Terry Gregg, vice president of regulatory affairs and clinical research, shepherds between five and 10 510(k) applications through the FDA yearly. MiniMed makes "micro-infusion" units, often worn under clothing, that deliver insulin under the skin to diabetics.

Gregg said he also has noticed a dramatic reduction in response time by the FDA. "We're averaging under 90 days for 510(k) notifications; in 1994, that time would have been closer to 300 days."

A 90-day approval would put the FDA at the maximum review time allowed by law. The FDA faces no penalty for exceeding that period, and according to its own figures, the agency has not been able to meet that limit on average since 1991.

Among the approaches Congress is taking in it efforts to help speed FDA approvals is a bill introduced in December by Sen. Nancy Kassebaum, R-Kansas, that would require that if the FDA is not meeting statutory time limits by July 1, 1998, it would have to contract with outside experts to conduct reviews.

For the fiscal year ended Sept. 30, 1995, the agency reported it met the 90-day deadline for review for about half the 510(k) applications.

The FDA's average review time for 510(k) requests increased from 81 days in 1991 to 102 in 1992, 162 in 1993 and 184 in 1994 before declining to 138 in 1995. Those average times do not include days the FDA had an application on hold to await further requested information.

Gregg said the FDA's efficiency is being enhanced by the agency's increased responsiveness to applicants. The FDA spells out better what it wants to see in applications and works more closely with MiniMed to guide the company through the process, Gregg said.

He added that he also is pleased that the FDA has speeded its export approvals for U.S.-made products approved for sale by a foreign country but not yet by the FDA.

Export permission "used to take upwards of six to nine months. In the last six months to 12 months, that's reduced significantly. Our last export authorization took seven days," Gregg said.

With faster reviews available in the United States, MiniMed, like Staar Surgical, has decided to conduct more clinical trials domestically rather than in Europe. This change is allowing MiniMed to add about a dozen regulatory and clinical workers at home, Gregg said. The company employs about 270 workers in Sylmar and 30 in other U.S. states.

The FDA is cooperating with MiniMed in its efforts to develop a new implantable infusion pump to deliver insulin to diabetics. It will fall into the category of breaktrough devices that require major pre-market application review from the FDA before approval.

Speeding up review and approval of pre-market applications, or PMAs, is a goal for the FDA in 1996, according to Dr. D. Bruce Burlington, director of the FDA Center for Devices and Radiological Health in Rockville, Md.

The agency trimmed its average PMA review time to 20 months in fiscal 1995 from 21.5 months the prior year. The statutory limit is six months, but again, there are no repercussions if the FDA fails to meet the requirement.

Bogging down

The average time spent on a PMA review has surged since 1992, when it was just under eight months. And that lengthening review time seems to have acted as a powerful disincentive to manufacturers. PMA submissions fell from 65 in 1992 to 40 in 1993 and 39 in 1995.

What caused review times for 510(k) and PMA submissions to bog down earlier in the 1990s? What caused the turnaround in the past year or so?

James S. Benson, senior vice president of the Health Industry Manufacturers Association trade group in Washington, D.C., was acting FDA commissioner during most of 1990. He traced the increased delays to problems implementing the Safe Medical Devices Act of 1990, which made applications more complex and detailed. Writing complicated regulations for putting the law into effect for the law took reviewers away from their regular duties, and Congress never fully funded implementation the new law, he said.

An intense congressional probe of the FDA medical devices unit in the early 1990s and criticism of the agency by a new FDA commissioner, David Kessler, distracted staff and hurt morale. Worries over silicone breast implants lengthened review times, too, Benson said.

Donald McLearn, an FDA spokesman in Rockville, Md., said it had taken time for the agency's Office of Device Evaluation to adjust to the sweeping changes required by the 1990 law. "In the early '90s, we changed the system. We built in steps and built in science. We were training new people," McLearn said.

Another factor contributing to the agency's increased efficiency in recent months has been that its staff was beefed up by 20 percent, or 65 people, in 1994 through a budget increase of $20 million.