Breakthrough at FDA

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published January 1996

James G. Dickinson

Through its grassroots regulatory partnership meetings held around the country, FDA seems to have successfully broken loose from the policy noose that is the Washington Beltway and opened a constructive dialogue with the medical device industry.

That is the impression created by a meeting in Washington, DC, last October between FDA's high command and industry representatives. Both sides described the meeting, which lasted an hour and 40 minutes, as very positive.

Representing FDA were David Kessler, the agency's commissioner; Michael Friedman, deputy commissioner for operations; Ronald Chesemore, associate commissioner for regulatory affairs; Gary Dykstra, deputy associate commissioner for regulatory affairs; Margaret Jane Porter, chief counsel; Ed Esparza, director of the Southwest Region; John Scharmann, director of the Denver district; Bruce Burlington, director of the Center for Devices and Radiological Health (CDRH); and Phil Phillips, deputy director of device evaluation at CDRH.

On industry's side of the table were John Boettinger, a consultant; Wendell Gardner of Cobe Laboratories, Inc. (Lakewood, CO), representing the Colorado Medical Device Association; Wayne Barlow of Wescor, Inc. (Logan, UT), representing the National Medical Device Coalition; Nancy Singer, special counsel for the Health Industry Manufacturers Association; Lynn Switzer of Quest Medical, Inc. (Allen, TX), representing the Medical Device Manufacturers Association; Ernest Malachowski, chief operating officer of IMEX Medical Systems, Inc. (Golden, CO); and Tom Hentleff, counsel for the Contact Lens Industry Association.

It was Gardner's idea to present the reform ideas to Kessler in person. At an August meeting in Denver, Gardner complained that the commissioner does not seem to be involved in the concerns of the device industry, despite the increasingly shrill attacks on the agency by device industry groups and members of the new Republican majority in Congress.

The prevailing opinion at the Denver meeting, as well as at the Utah International Medical Device Congress a week earlier, was that nothing short of major legislative surgery would make a real difference at FDA. There was some support for that view even from within the agency itself. Deputy associate commissioner Dykstra told the Denver meeting he could not speak on behalf of Kessler because he had not discussed the meeting or the specific issues involved with him before coming.

After the attendees named a delegation to seek a meeting with Kessler, his deputy commissioner for external affairs, Sharon Holston, said the chances of such a meeting occurring were somewhere between "slender and nil." But when this writer cut through the bureaucracy and asked Kessler directly, he said he would be happy to meet with the group.

After the Washington meeting, almost everyone who attended expressed surprise at how well it had gone. Not only was FDA's spirit positive and optimistic about achieving, in some measure, most of the things indus- try asked for, but an animated Kessler directed Chesemore to begin work immediately on three inspection-related requests that everyone agreed could be done. Furthermore, Kessler instructed Chesemore to report on these issues to Gardner, the industry group's leader, within two weeks.

The first request would give companies advance notice of FDA inspections when the agency has determined that such companies want to be in compliance. Companies that are the subject of "for cause" inspections would not be given notice, however.

The second request would allow companies under inspection to make corrections during those inspections. The problems would then not appear on a notice of inspectional observations, or FDA-483. (There was even a recommendation that companies be given a draft of their FDA-483 with 24 hours to effect changes to the final form, but this would be a hard sell to FDA district offices because of the time and resources such a measure would consume.)

The third request would give companies a formal statement of closure once the issues raised in an FDA-483 have been resolved. Doing so would provide companies with a document to show foreign governments and prospective customers concerned about the previous warning letter or notice of inspectional observations.

In addition to updating Gardner on these issues within two weeks, Chesemore was directed to name contact persons at a high level within FDA to pursue these and other issues, in collabora-tion with industry, to their conclusion. A precise mechanism for doing so was not worked out, but Gardner said afterward that he intends to keep the process moving forward.

Based on the meeting, a frontal attack on the FDA "culture" problem is high on Gardner's agenda. One possible solution is joint training of lower-level FDA and industry people. Gardner believes that those who are trained together cannot help but gain a better understanding of one another, which in turn should reduce mutual suspicion.

As was pointed out at the meeting, suspicion is a formal FDA regulatory tool and thus a major cultural barrier between the agency and the device industry. Chapter 150 of the FDA Investigator's Operations Manual declares, "All regulatory procedure is designed to discover and develop evidence of violations with the ultimate aim of assuring compliance with the law to assure protection of the public health." How can FDA expect to establish a partnership with industry when it teaches its employees to have that attitude? That's a problem, admitted the FDA leadership, but "we're work-ing on it."

FDA's relationship with industry is bedeviled by such contradictions. Take, for example, its choice to begin coupling prod-uct approvals with a company's GMP (good manufacturing practices rule) status, implemented in the so-called reference list, which the agency subsequently had to disavow. Major policy changes of this sort ought to be arrived at in the open, through notice-and-comment rule making--even if the law does not explicitly require it. Even though the maintenance of such a list would obviously have a wide impact and engender controversy, FDA implemented it in secret and withdrew it only after years of protest from industry.

Industry, of course, shares some of the blame. Well-funded Washington-based trade associations seem almost to foment such behavior by rigidly holding the agency to legal criteria, filing petitions, and networking their criticisms on Capitol Hill--all to inhibit FDA from doing anything that does not conform strictly to both the letter and their interpretation of the spirit of the law. This war of nerves inside the Beltway, waged in the spirit of constitutional checks and balances, is part of what supposedly keeps government agencies honest, if not necessarily efficient. The war also breeds unnecessary suspicion and even paranoia, however.

But when FDA decided to meet industry as a partner in the grassroots meetings, it found that representatives of the trade association member companies were willing to deal with it on a completely different level. "We recognize that trade associa- tions don't represent the whole industry," said CDRH director Burlington, "but this [meeting] gets us outside the Beltway."

FDA and the device industry appear to have stepped away from the typical way of doing things in Washington and embarked on a course that shows more promise. By dealing with industry directly, instead of through intermediaries who might have their own agendas, FDA may be able to craft its own palatable reforms, rather than having more drastic measures imposed by Congress. An important question to ask, however, is, How much of this would have come about without the threat of legislation?

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.