Medical Device & Diagnostic Industry
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Originally published May 1996
Judging from a number of developments at both the national and regional levels, FDA appears to be undergoing a veritable transformation--a shift in culture that is bringing many in the agency to view device manufacturers as partners rather than as adversaries. While the watchdog agency has sporadically paid lip service and little else to such a change, there are now clear signs that the idea has taken root.
FDA headquarters will soon put into effect a pilot program that will test new procedures for GMP inspections. If implemented permanently, the new procedures could smooth the process and ease the burden on medical device companies undergoing inspections.
The pilot program is designed to test the feasibility of three major procedural improvements. First, rather than every inspection being a surprise, FDA will give qualified companies advance notice of upcoming site visits, enabling them to make preparations for a smooth and efficient inspection. Second, inspectors will tell the company about violations as they are uncovered and, if those violations are corrected prior to completion of the inspection, the corrective action will be noted on the FDA-483 list of observations. Third, FDA will provide a closure document after an inspection is completed, formally noting when issues listed on an FDA-483 are resolved.
The program was announced on March 15 in a letter jointly issued by FDA associate commissioner for regulatory affairs Ron Chesemore and device center director Bruce Burlington. Although no date was given for formal promulgation of the program in the Federal Register, implementation is expected to move rapidly. "FDA has already been moving ahead with the program internally, doing some training--basically greasing the skids," says Wendell Gardner, senior vice president at Cobe Laboratories, Inc. (Lakewood, CO), and a key participant in the development of the initiative. "There is no more review of this program left to do."
According to Gardner, FDA will not wait for industry comments about the program before beginning implementation, but will instead consider comments arising from the Federal Register publication at the same time as it evaluates the results of the pilot program, which is scheduled to last until the end of this year. "This is a really good program and the agency has taken a very reasonable approach," Gardner says. "We have all the FDA districts onboard and ready to work with it."
This nationwide program is only the most visible effort at improved industry-FDA relations to grow out of last year's series of regional "grassroots initiative" meetings, which brought together industry and FDA representatives to discuss their differences. In the wake of those meetings, FDA field offices appear to be taking a genuine interest in developing ways to improve communications with medical device companies. This interest has taken a number of different forms.
The Southwest Region has scheduled a meeting of frontline regulators and representatives of the medical device industry to examine how the two sides can work together more effectively during the FDA inspection process. The idea is "to gear the process more toward problem solving and not confrontation," says Marie Falcone, small business representative for the FDA Southwest Region (Dallas).
More such joint training sessions are expected in the future in each of the three districts in the Southwest Region. In some, company project engineers and FDA staff, including inspectors, will tell each other about their jobs and the pressures they are under. "We don't want to get into touchy-feely things, but we do want to have a mutual understanding of where we are coming from," Falcone says. "The end purpose is to build trust." Other training sessions will be more technical, with industry experts bringing FDA investigators up to speed on new manufacturing technologies, particularly in computers and metals testing.
This shift toward FDA cooperation may be a combination of several forces acting independently yet having a cumulative effect. Ed Esparza, Southwest Region director, credits agency's growing recognition that the American medical device industry is competing on a global stage. "We recognize that FDA has an impact on the worldwide economy," Esparza says. "We must ensure that we are not an impediment to our industry's getting new products to market and being competitive in the world trade arena."
The rising emphasis on cooperation may even have come from individuals such as Ron Johnson, former director of the device center's Office of Compliance, who recognized problems in the field that were beyond his reach before becoming FDA's Pacific Region director (San Francisco). "When I was at the Center for Devices and Radiological Health, I had a pretty good sense for industry concerns about field activities, but I didn't have any control over them," Johnson says. "When I came out here, I was able to address some of them."
The Pacific Region has been a pioneer in the current effort to improve communications. Even before the nationwide inspection initiative was proposed, the Pacific Region had instituted a policy of advising companies about violations as they were uncovered during an inspection. The region's policy also called for field offices to respond to written requests about the status of an FDA-483. "We acknowledge receipt of letters asking about FDA-483s, and we say whether it looks like the company responded reasonably," Johnson says. Other aspects of the national initiative--such as annotating FDA-483s during an inspection to verify that violations have been fixed--"were more than we were able to do locally," he explains. But opening the communications process was a step in the right direction, he says.
Since then, the Pacific Region has taken several more steps toward improving relations with industry. FDA staff have contacted the companies attending the grassroots meetings in the region "and we have continued the dialogue," Johnson says. The Pacific Region has also publicized the names of district directors along with their direct phone numbers. "Just knowing who the players are and sharing information on a regular basis helps," he says. These directors have also assured Johnson that they are committed to meeting with industry representatives without putting any restrictions or conditions on the topics to be discussed. "Any company that has a need to talk to top management of the districts or Pacific Region can now do so," Johnson says.
Another step along the path to better relations with industry was the identification of a person at the Pacific Regional Office who will handle requests from companies seeking their current regulatory status. "A company that is getting ready to submit an application to CDRH and wants to make sure there is nothing in GMP compliance that will hold it up, can find out very quickly," Johnson says. In the near future, the Los Angeles district is expected to begin experimenting with an ombudsman project in which a staff person is assigned to help companies that are experiencing regulatory problems. "That person will shepherd them through the system to resolve the issue, whatever it might be, whether they have a PMA hung up or something else has gone wrong," he says.
While there may be many individual forces behind the agency's sudden interest in corporate concerns, the undercurrent is probably the FDA reform effort launched by the Republican leadership of Congress last year. "There is no doubt in my mind that the pressure from Capitol Hill was one of the major motivating factors toward the reform now being seen at FDA," says George Burditt, a principal in the Chicago law firm of Burditt and Radzius, which represents medical device companies. "But I also believe there are a lot of very strong feelings within the agency that they want to reform--that they want to do things better."
Gardner agrees with that assessment. "I think at least some in FDA believe that they need to change their culture," he says.
Pacific Region director Johnson appears to be one of them. "We're trying to get both industry and government to deal with broader issues in collaborative ways," he says, "so we can solve problems before they become nightmares."--Greg Freiherr *