FDA BREAKUP: "AMPUTATION" OF REGULATORY BODY TO SEPARATE DRUGS AND DEVICES

Executive Summary

FDA BREAKUP: "AMPUTATION" OF REGULATORY BODY TO SEPARATE DRUGS AND DEVICES from foods and cosmetics is not the answer to making the agency better able to handle its caseload of drugs, biologics and biotech products, former FDA Commissioner Arthur Hull Hayes, MD, told a Capitol Hill seminar on Oct. 29. Hayes alluded to informal suggestions from Edwards Committee members and recommendations from the Lasagna Committee that FDA relinquish its responsiblity for foods, devices, radiological products and cosmetics. "The first thing one does not do to cure the common cold, appendicitis or pneumonia is to amputate the arm, followed by below the left knee, and then maybe part of the left face," Hayes said. Speaking at an Institute for Alternative Futures Foresight Seminar on the role of FDA in the 1990s, Hayes said: "I don't think there is much merit in addressing FDA's problems and responsibilities -- budgetary especially -- that the first answer ought to be take it apart. If one thinks that those responsibilities could be better done or more efficiently and cost effectively done elsewhere by reorganizing FDA, then it ought to be done under a different guise, not that we're going to save money." Hayes said the breakup of FDA would accomplish little if the reconstituted parts received the same amount of resources now given to the unified agency. Leaving FDA with responsibility for only drugs and biologics, and even devices, with the assumption of producing greater efficiency under the same budget allocation from Congress "is a snare and a delusion," Hayes told the seminar. He added that FDA's current mission "ought to be maintained, perhaps focused, perhaps [with] clearer priorities [and] allocation of resources...[Do] not start changing what [FDA] does or start taking it apart, because I don't think that it will work." The seminar's two other speakers, former FDA Commissioner Alexander Schmidt, MD, and former FDA General Counsel Peter Barton Hutt, concurred that FDA's functions should not be narrowed. Schmidt said FDA's current regulatory role must be "perceived to be maintained," arguing that it is important that the American consumer and the Congress have confidence in the agency's ability to handle its delegated tasks. Hutt agreed, saying that the issue is "not just an economic stake but a health and safety stake." On the issue of FDA independence, the three speakers agreed that the agency should remain under the aegis of HHS. However, they also pointed out that the authority of the commissioner, which they agreed diminished during the Reagan years, needs to be restored. Noting that being part of HHS and of the Public Health Service creates its own layers of bureaucratic problems and delays, Hayes nonetheless declared that "there are some advantages to being in the department" because FDA, through the HHS secretary, has a Cabinet-level advocate. Hayes also said that since 1981, the commissioner has enjoyed "less independent, unreviewable, before the decision is rendered, authority. The recission of that authority made it very clear." Schmidt quipped: "As far as their stature goes, I suppose they're just as tall, but their authority has gone to hell."