|THE CHANGING ROLE OF EDUCATION IN FDA'S REGULATION OF MEDICAL DEVICES|
John C. Villforth, President, The Food and Drug Law Institute (Washington, DC)
Joseph S. Arcarese, Vice President, The Food and Drug Law Institute
FDA has for years struggled with the merits of voluntary compliance and education as complements to its traditional regulatory role. Within the agency, the Center for Devices and Radiological Health (CDRH) was for many years one of the chief promoters of the educational approach to protecting public health. Other FDA components argued for a stricter interpretation of the law, seeing the agency's mission in purely regulatory terms and viewing collaborative problem-solving with industry quite skeptically. Now, in the 1990s, with some exceptions, the educational approach seems to be waning, and the device center appears to have adopted a more traditional regulatory approach in dealing with industry.
Prior to joining FDA in 1971, the Bureau of Radiological Health (BRH) implemented a strategy involving both education and regulation in the control of unnecessary radiation exposure from electronic products. The bureau's concept of education was very broad, incorporating information exchange, scientific research, and problem-solving in collaboration with manufacturers, health professionals, and consumer organizations.
This concept, combining regulation, research, collaboration, and education, was codified in the Radiation Control for Health and Safety Act of 1968, a model law amending the Public Health Service Act. This multifactorial approach was very successful, especially when certain health problems it confronted were not amenable to straightforward regulation directed only at the equipment and the manufacturer. Having proven the approach's utility, BRH continued to use education as a public health tool along with regulatory compliance.
Anticipating passage of the Medical Device Amendments of 1976, FDA established the Bureau of Medical Devices (BMD) in 1974. Despite testimony at the congressional hearings leading to the amendments, where the strong role of the user in device safety and effectiveness was recognized, these amendments laid almost total responsibility on the manufacturer. BMD complied with the amendments' mandate and implemented its program accordingly. However, it did include a small educational group, the Office of Small Manufacturers Assistance (OSMA) (now known as the Division of Small Manufacturers Assistance), whose focus was on helping device manufacturers understand how to comply with the law. BMD also had a consumer affairs group, which promoted educational programs for the public, and a health affairs office that communicated with health professional organizations.
In 1982, BMD and BRH were merged to become CDRH. The new center incorporated the broader BRH vision of education into its structure by including the offices of Training and Assistance (into which it folded OSMA and the consumer affairs group), Science and Technology, Health Affairs, and Standards and Regulation. What distinguished CDRH from most other FDA centers, however, was not its activities to disseminate information to manufacturers, health professionals, and the public--which many centers did to one extent or another--but rather its programs to achieve consensus among these groups regarding various device-related health-care problems. In meetings with representatives of appropriate organizations, CDRH staff facilitated problem-solving discussions that developed cooperative programs to decrease the risk and increase the effectiveness of certain risk-laden device technologies. Anesthesiology, dialysis, central venous catheters, prenatal ultrasound, and contact lenses were some of the areas of discussion that led to the establishment of cooperative programs.
The center's anesthesia program, for example, has been remarkably successful, and large reductions in avoidable anesthesia deaths and injuries have been reflected in lower malpractice premiums for anesthesiologists and fewer product liability cases. It has demonstrated the efficacy of a win-win philosophy, according to which government can work collaboratively with other affected elements of society to achieve public health goals.
Unfortunately, such success stories are not likely to be repeated. The 1990s have seen FDA continue with its more traditional view of education as one-way communication. Although the agency continues to make full use of its advisory committees, special public meetings, and notice-and-comment rule-making procedures as means of obtaining outside input, it rarely if ever cedes its prerogatives by participating in cooperative problem-solving with other organizations.
FDA is now under withering fire from its critics, especially regarding product review. It is successfully implementing a number of internal administrative changes to increase its productivity. But whether these influences will open the agency as a whole and CDRH in particular to reconsider a broad understanding of education in its mission strategy remains to be seen.
John C. Villforth is a former director of FDA's Center for Devices and Radiological Health (19821990) and of its predecessors. Joseph S. Arcarese is a former director of the device center's Office of Training and Assistance (1984 1993). The views expressed are those of the authors and do not
represent the Food and Drug Law Institute.