Originally published September 1996
James G. Dickinson
Here's a list of dreams long dreamt by members of the medical device industry:
* FDA inspections scheduled a week in advance by day and by subject to be covered.
* Faster establishment inspection reports (EIRs).
* No-surprise FDA-483 notices of investigators' observations.
* Cross-training of industry and FDA employees at the same technical workshops.
* Collaborative drafting of FDA compliance policy guides that instruct agency investigators.
These dreams are but a few of the FDA reform realities being networked at FDA-industry grassroots meetings around the country. Combined with pilot testing of external product reviews by FDA's Center for Devices and Radiological Health, the earnest changes under discussion in the grassroots meetings add up to a new age for FDA and its relationship with industry.
"When I joined the agency in 1960," FDA Chicago district director Raymond Mlecko told over 100 device industry representatives at a grassroots meeting on June 28, "we wore white hats, and you guys wore black hats. Now it's you who are wearing the white hats!" He said it jokingly, but his words underscored those of his boss, FDA Midwest regional director Burton Love. At a Chicago grassroots meeting with drug industry representatives a few days earlier, Love had said, "It's not just talk. There is going to be less government." FDA's concern, according to Love, is that with an anticipated 30% cut in resources for its field operations in 1997, the agency won't be able to protect the public without optimum cooperation from industry. The agency's traditional investigator culture is consequently moving away from the "up against the wall and spread 'em" mentality of the past to a kinder, gentler problem-solving approach.
At the June grassroots meetings in Chicago, Mlecko had a dozen of his investigators contribute their perspectives to the mix of industry ideas being worked on in various breakout sessions. The resulting reform suggestions were then to be compiled within weeks by Chicago district program analyst Marvin Mortensen into a report that would be mailed to all participants and to associate commissioner for regulatory affairs Ronald Chesemore.
With FDA's national pilot program of medical device inspection reforms (preannounced inspections, annotated FDA-483 notices, and formal closeout letters) already launched, the grassroots meetings now focus on initial feedback from the pilot program and a host of new reforms. Feedback in Chicago was enthusiastic. Overwhelmingly, representatives of companies that had received preannounced inspections applauded not only the way they were done, but the demeanor of the reoriented FDA investigators conducting them.
The main benefit of preannouncement, they said, is that companies are able to gather the needed records in advance so that time is not wasted looking for documents after the investigator requests them. Some Chicago district investigators even schedule specific records for specific days, a week in advance. And if any of the scheduled days is inconvenient to the firm, the investigator tries to schedule an alternative. Another important benefit is that the company is able to make sure that the appropriate staff are on hand for the inspection.
Taken together, these two benefits add up to an inspection that may be completed in half the time it would have taken under the old practice of unannounced inspections. Of course, if significant problems are encountered, the inspection may drag on, and all bets are off if a possible prosecution enters the scenario. On that score, Mlecko's investigators repeatedly tried to reassure the grassroots meeting that they want to avoid prosecution. "We don't like going to court any more than you do," one commented.
FDA's traditional concern that giving companies advance notice of an inspection, and of the documents to be examined, could lead to falsification of records seems to have disappeared in the new-age agency, along with the basic operating assumption that there are malefactors in every company. I asked five of Mlecko's investigators about this, and each said they have other means of detecting false documents. It is no longer necessary--if it ever was--to ambush companies to find document falsification.
To me, that says a lot about the new spirit controlling the agency's enforcement arm. The basic assumption of industry crookedness has changed--or, to be more cautious, is changing--to an assumption that industry has the same goal as FDA, namely, patient safety.
The openness and apparent candor of the exchanges between FDA and industry personnel at both grassroots meetings was surprising both to me and to Mlecko, who asked me later how it compared to others I had attended. He was obviously wondering whether it was unique to his district. I told him it did seem unprecedented to me, although I had not been to every grassroots meeting in the nation.
Assuming that there was candor and openness in Chicago, it was revealing that no industry attendee expressed the view that FDA should have fewer inspections, or curtail the intrusiveness of inspections. They did not even complain about the public availability of FDA-483 notices or EIRs. In short, they supported FDA's statutory obligations and appeared to recognize that compliance with them could strengthen their companies' standing in the domestic and international marketplaces.
The point of departure in this collegiality was efficiency. Doesn't FDA realize, several industry attendees demanded, how upsetting it is to have an inspection interrupted, sometimes for a month or more, because the investigator suddenly has to rush off to deal with a higher-priority matter? And does it make any sense to require companies to file a Freedom of Information request for their own EIR? And how can FDA pretend that the EIR isn't ready when it has written a warning letter that must depend on the existence of a finished EIR?
The FDAers present admitted to the logic of such criticisms and promised to try to make their bureaucracy behave more efficiently in the future. Whether or not the bureaucracy will respond appropriately remains to be seen. Some industry cynics believe that nothing truly meaningful will happen without a legislative hammer to pound on that bureaucracy. In their minds, the only reason the agency is today giving the appearance of paying attention is that Congress has been diligently working on serious and tough legislation. If the Democrats take back Capitol Hill in November, these cynics contend, the old FDA will rise again.
I doubt it. The radical changes earnestly being discussed at grassroots meetings and on the 14th floor of FDA's headquarters in Rockville owe more to the Clinton administration's "Reinventing Government" initiatives, which began before the Republicans took over Congress, than they do to the extra catalyst that the Republican majority later provided. In fact, some of the reform ideas now in the spotlight actually began inside FDA before Vice President Al Gore's Reinventing Government drafting team asked the agency for its contributions.
Changes this fundamental do not come overnight, or in response to any single initiative or crisis. They evolve over many years, and involve the talents of many people and many constituencies. The fact is, most of this work has already been done now. What we are witnessing in the FDA reform movement, both on Capitol Hill and in the grassroots meetings, is the coming together of the various ideas for change, some well considered, some not. Out of it all, and independent of any bill on Capitol Hill, a new-age FDA is emerging.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.