Originally published May 1996

Larry R. Pilot

Partner, McKenna & Cuneo (Washington, DC)

From FDA's founding in 1938 to the mid-1970s, seizures, injunctions, and criminal prosecutions entered into by the agency were confined primarily to devices associated with fraud or quackery. Few actions were directed against devices applied by licensed practitioners. But on May 28, 1976, with the stroke of President Gerald Ford's pen, FDA acquired a comprehensive statutory mandate that far exceeded its historical reach.

The Medical Device Amendments of 1976 were the product of nearly six years of dialogue between Congress, FDA, the medical device industry, consumers, and the health-care community. There was little opposition to these major amendments. Instead, their signing into law was accompanied by great expectations that they would provide a model for thoughtful and balanced federal regulation of medical devices.

Today Congress is trying to understand what went wrong and what can be done about it. An enforcement-oriented FDA has tarnished the image of the medical device industry, discouraged domestic R&D, and deprived the American public of technological advances.

FDA inspection of facilities represents the foundation of nearly all enforcement initiatives. It is the conduct and management of this activity that has changed remarkably over the past 20 years and created an atmosphere of despair and animosity.

During their first few years, application of the 1976 amendments and the 1978 good manufacturing practices (GMP) regulation was accomplished through good communication and great cooperation between government and private enterprise. FDA clearly explained its intentions and expectations; industry understood and accepted them. The responsibility of direction and management of enforcement initiatives was accomplished at headquarters through the Bureau of Medical Devices and its successor, the Center for Devices and Radiological Health. Seizures, injunctions, and prosecutions were rare. The regulatory letter was the major method that FDA used to warn manufacturers that it believed were responsible for major violations.

During the 1980s the seeds of destruction were sown and fertilized by congressional investigations. Punishment for scandals that arose concerning the generic drug industry was meted out to a naive device industry through the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

But it was the 1990 appointment of a new and inexperienced commissioner, David Kessler, that has had the greatest impact on FDA's enforcement policies. With little evidence to demonstrate that harsher enforcement would produce safer or more effective devices, Kessler has instituted an enforcement regime that has created a regulatory nightmare for industry.

For example, the agency's combination of the traditional notice of adverse findings and regulatory letter into a single, all-purpose warning letter has produced chaos. In the early days, only FDA headquarters issued regulatory letters, and only when the relevant FDA district director supported such an issuance with evidence that could likewise support a seizure or injunction. Because they were backed by evidence and by the full authority of the agency, regulatory letters were taken very seriously by the manufacturers that received them.

Today, FDA has abandoned the desirable benefits associated with such competent, centralized decision making. Instead, the agency has instituted a policy whereby each of the 21 regional directors is empowered to issue warning letters, and no independent evaluation of evidence is required. Because of these loose evidentiary requirements, recipients now commonly consider warning letters to be merely very embarrassing, but nevertheless hollow, threats. The folly and ineffectiveness of the current warning letter is illustrated by a comparison between the number of letters and corresponding enforcement actions undertaken in fiscal years 1980 and 1994 (see table below).

There is today hope that congressional hearings aimed at reforming FDA will soften the agency's enforcement policy and lead to a recognition that the majority of medical devices and their manufacturers are in compliance with a sensible interpretation of the law. Such a recognition and consequent change in attitude would be important steps toward regenerating an environment, philosophy, and management approach that in the early years of the Medical Device Amendments of 1976 produced a cost-effective public benefit.

Larry R. Pilot was the first director of compliance at FDA's Bureau of Medical Devices (1974­1977).