Originally Published MDDI April 2001
Editor's Page
Director's Cut: CDRH Chief Extends HimselfCDRH director David Feigal conceives the quest for safety and effectiveness as a cooperative venture with industry for mutual success.
Until recently, top FDA bureaucrats tended not to linger at medical device industry gatherings. If slated to deliver a speech, for example, the official in question would rush in—surrounded by a phalanx of aides—at the precise moment indicated on the schedule, recite a brief mantra about the health and welfare of American women and children and the dire penalties facing those who would threaten them with defective products, and beat a hasty retreat before the aggrieved and fuming crowd of manufacturers.
Well, things have changed. At last month's AdvaMed (formerly HIMA) 2001 Annual Meeting held in Rancho Mirage, CA, the presentation of CDRH director David Feigal, MD, on "What FDA's Changing Mission and New Initiatives Mean to You," was anything but perfunctory. In fact, everything from the personalized slant given the title of his talk to its candid, reasoned discourse to its length—in his enthusiasm, Feigal went on so long that the next speaker, AdvaMed's incoming chairman, happily postponed his own address and sent everyone off to dinner—confirmed that, as far as Feigal was concerned, the days of antagonism and confrontation were over. "We're in this to- gether," Feigal told the audience, "and FDA doesn't succeed if you don't succeed."
Among the "successes" that Feigal claimed for the agency, post-FDAMA product approval times headed the list. The average time to approval for a PMA is now about one year—half of what it was five years ago. PMA supplements are being processed in about four months, and 510(k)s in approximately three months, with slowly increasing use of abbreviated and special 510(k)s.
Third-party review has met with only limited acceptance, Feigal admitted, even though the number of devices eligible for the program has more than quadrupled since 1998, and now encompasses 70% of all 510(k)s. While acknowledging that third-party review is essentially a "fee for service," Feigal enumerated the potential benefits to manufacturers, which include review times averaging two-thirds those of FDA and the growing expertise of several third-party reviewers in specialized new technologies such as genomics-related products. The director also expressed satisfaction with the first year's efforts of the FDA ombudsman, who intervened in 35 complaints or disputes between industry and FDA and managed to resolve about half of them, with more than 80% of the outcomes in favor of manufacturers.
In laying out CDRH's strategic goals for the future, Feigal envisaged a shift from the traditional premarket/postmarket regulatory model to a "new paradigm" based on oversight of the "total product life cycle." FDA would work with manufacturers to ensure product safety and effectiveness throughout the entire cycle—from conceptual, prototype, preclinical, and clinical phases through manufacturing, marketing, commercial use, and obsolescence.
Despite the meeting's desert setting, Feigal did evoke a few troubling clouds on the horizon: FDA's serious dearth of resources and rapidly aging workforce. (CDRH has entire divisions, he reported, in which everyone is over 60.) There are now nearly 50,000 medical establishments under the agency's jurisdiction—a figure equal to the number of food companies. About 7000 of these supply Class II or Class III products and are supposed to be inspected every two years, yet FDA conducted only 1841 inspections in 2000, a 50% decline from 1996. At the same time, device recalls have risen to an ominous 1000 per year.
Without some money from the budget brokers in Washington and some fresh bodies in the reviewers' chairs, said Feigal, FDA will be hard pressed to meet its avowed goal of consumer protection that promotes both public health and prosperous business.
Jon Katz Copyright ©2001 Medical Device & Diagnostic Industry
jon.katz@cancom.com
