Medical Device & Diagnostic Industry Magazine
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Originally published November 1996

James G. Dickinson

FDA reform legislation began dying as Congress adjourned for its August recess, but that doesn't mean that the old FDA will come back on the rampage, bigger and meaner than ever, as some reform advocates have warned. The truth is, that old dragon had already been fading, partly of its own accord and partly out of budget-borne necessity.

The demise of reform legislation in Congress comes as a bitter blow to the many earnest reform proponents in industry. Among them was Jeffrey Kimbell, executive director of the Medical Device Manufacturers Association. His disappointment showed in an obituary-like August newsletter report: "I regret to inform the membership that our vote on FDA reform, originally scheduled for July 30 in the U.S. Senate, has been delayed because of a very crowded legislative calendar. . . . This unfortunate postponement, coincid[ing] with the House not taking any action on the bill in subcommittee or full committee before the August recess, reduces the chance of enacting any meaningful legislation this year."

To speculate before the November election on the chances of successful legislation next year might seem reckless. But in the interregnum, more than a few knowledgeable observers have spoken loosely of the "pendulum"—their implication being that the political bias of national affairs is due to swing back from the right toward the center, something that House Speaker Newt Gingrich had apparently decided was indicated for his own public statements. That makes it less likely that even the current Congress, if returned intact, would have FDA reform as high on its agenda next year as this year. And if it is restructured by the voters, this hypothesis suggests it will be a more-leftward Congress and even less likely to resurrect FDA reform legislation.

While Congress stumbles over agency reform, FDA continues strenuously working—and networking—to make legislation unnecessary. Central to its efforts and those of its industry advisers has been the goal of achieving a major attitude adjustment, especially among field investigators. "I am alarmed to still hear regulators describe their job as to 'kick butt,'" wrote FDA Office of Regulatory Affairs human resource development director Gary German in August, in his debut as the editor of the Association of Food and Drug Officials (AFDO) newsletter.

AFDO is the association of both federal and state regulators. This year it formally adopted medical devices as a focus of collaboration, staging two regional workshops in San Francisco and San Antonio to help FDA's Division of Small Manufacturers Assistance orient device manufacturers to all aspects of medical device regulations, including the new medical device reporting (MDR) regulations that became final on July 31.

German's editorial reflects what is happening to FDA's attitude. Importantly, his office of resource management is located within the headquarters enforcement office that directs field operations nationally.

His editorial extolled the virtues of the reinvention of government "revolution," which he saw as coming from the American people themselves, through industry and government. "I have heard in both my professional and personal life many indications that the revolution is real," German wrote. "A news reporter talked about one of the biggest ills of society being a government that is not responsive to the people. The same reporter indicated that a large percentage of the American people are afraid of their government. A CEO reported how he longs for a dialogue with the agency that regulates his firm. He indicated his desire to be in compliance, but they [the regulatory agency] treat everyone like crooks."

German deplored this state of affairs. "The revolution appears to me to be the major issue facing our members and the regulatory agencies that are our members. We as regulatory officials must be day-to-day players in the reinvention efforts. Our industry members need to recognize these efforts as sincere and step forward to offer their assistance in the change."

At AFDO's San Antonio meeting, local resident post supervisor Jack Davis produced some interesting statistics about the developing fusion of FDA and state inspections of medical device companies. Driven by budget cutbacks—fostered by medical device industry interests seeking less money for FDA enforcement and more for device approvals—FDA has contracted out more than 45% of its Class II and Class III medical device facility inspections in Texas to the state's health department.

This arrangement is becoming more common across the country. Although the inspections are conducted under FDA auspices, performed by FDA-trained state employees, paid for by FDA, written up on FDA-483 report forms, and analyzed by FDA for any follow-up actions, they raise many intriguing questions. Are the inspections as thorough or as competent? Are the inspectors more or less reasonable or diligent? Is FDA's presence in regulatory situations diluted? Can any amount of training by an outside entity that is not your employer convey the depth of core culture that may help both sides when unusual conditions are encountered? Can inspected firms reach appropriate understandings as readily with an agent as they might with the principal? For many firms, contact with the local FDA inspector may be the only hands-on experience they have with FDA. Does the loss of this matter?

At AFDO's San Antonio workshop, presented by FDA professionals from Washington but attended by both FDA Southwest Region and Texas state officials, it was interesting to see how everyone mingled—or didn't—during the coffee breaks. The FDA people talked easily with industry personnel and seemed eager to answer questions privately. The Texas inspectors, on the other hand, did not mix, seeming to prefer to remain somewhat aloof, even coplike.

This impression was reinforced by the announcement at the workshop that the Texas department was not participating in FDA's pilot establishment inspection program. Under this relaxed program, advance notice is given of inspections, FDA-483s are annotated, and close-out letters are sent after inspection. But perhaps the decision was FDA's, to avoid potential complications to what was officially just an experiment.

As FDA's budget crunch bites deeper next year, assuming a continued de-emphasis on enforcement, we can expect more states to be contracted to do FDA inspections. Such arrangements also seem to be at the heart of FDA's plans to regulate cigarette vending machines and advertising aimed at teenagers. The agency has no resources to mount such an effort itself directly; sources indicate the agency will be looking to the states for help.

Philosophically, this trend seems to comport with the pendulum theory—an historic shift of federal power back to the states, in which FDA's role is only part of a whole.

Copyright© 1996 Medical Device & Diagnostic Industry