An $11 million increase in funding for the Food and Drug Administration’s medical device program could result in more, better-trained inspectors and a cut in the time it takes local biomedical companies to bring their products to market, according to local executives. As part of a $78 billion agricultural bill signed by President Clinton late last month, the FDA’s total device program funding is set to increase 7% to $180.2 million for fiscal 2001 with about $7.7 million in new funds slotted for device reviews. Any increase in FDA device program funding is “extremely positive,” said Patricia Garvey, vice president of regulatory and clinical affairs for Irvine-based heart valve and device maker Edwards Lifesciences Corp. What’s needed are more FDA device program inspectors with enhanced training to keep up with new technologies, she said.
As it is, device program inspectors “are overworked,” Garvey said. “There are too few to look at all the applications.”
Inspections are a key part of what the FDA calls pre-market approvals, particularly for high-tech devices that could pose significant risks to patients, Garvey said. “There have been delays in scheduling and completing inspections,” she said.
A recent FDA report showed that in fiscal 1999 pre-market reviews averaged 102 days for devices covered under what’s known as the administration’s 510(k) process, and 380 days for more advanced devices that require clinical trials.
“I’m optimistic that increased funding will help make (reviews) more streamlined,” said David Mercer, chief executive of Interpore Cross International, an Irvine-based bone graftsubstitute maker. At Interpore, most of the company’s devices under development fall under the FDA’s Class II category, Mercer said. Class II devices include certain kinds of lasers and ventricular assist devices. Class II devices generally have to go through the FDA’s 510(k) approval process, which is supposed to take place within 90 days. Pre-market approval for Class III devices, on the other hand, may lag a year or two or more. Even if the pre-market review process is streamlined, Mercer said, the onus still is on device makers to perform clinical trials expediently. Mercer said it took Interpore roughly 10 years from the time it started clinical trials on its bone graft substitute to gain FDA approval in 1992, the year he joined the company. As for the FDA, officials requested the increased device program funding to prepare for what they referred to as a new age of rapid biomedical technological funding. The agency said that tight budgets and declining staff levels had affected rapid review and approval of new medical technology. “I congratulate the FDA on coming to their senses,” said Dave Anast, editor and publisher of Biomedical Market News in Costa Mesa. The Medical Device Manufacturers Association, a Washington, D.C.-based trade group that counts Irvine-based Allergan Inc. among its members, has pushed for more FDA device program funding. In published reports, Stephen Northrup, the association’s executive director, said that increased and more regular medical inspections would bolster consumers’ faith in the reliability of new and existing medical technology. “Ultimately, this is good for the patients. They will benefit,” Garvey said. n
