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Executive Summary

ANDA DRUG APPROVAL PROCESS COULD BE SUPPLANTED by an abbreviated notification system relying on USP specifications to assure bioequivalence, former FDA Commissioner Jere Goyan suggested at a Dec. 13 seminar for FDA staffers at the agency's headquarters in Rockville, Maryland. "I am really intrigued by a proposal that was made by Bill Heller and Jerry Halperin" of the United States Pharmacopeia, Goyan said. "What they suggest is that the agency ought to get out of the ANDA review and basically use compendial standards -- and have the USP set the standards including bioequivalence standards." Using the model of the abbreviated premarket notification system used for medical devices, the 510(k) system, FDA could require a generic manufacturer to inform the agency in advance of its intention to introduce a product. "If the agency doesn't respond [within a specified] period of time," then the generic would be allowed to begin marketing. A notification, instead of approval, approach would permit FDA to concentrate on policing the process instead of taking part in the premarketing approval, Goyan observed. The agency could use its resources on GMP inspections, sampling and other enforcement mechanisms. The USP approach, Goyan said, "would have the support of the medical and pharmaceutical community in the standard setting in a way which is very difficult for the agency to get. And it would include those best qualified to set those standards." He also contended it would have a positive effect on resource allocation at FDA, and suggested a similar system for OTC drug approvals in the future. Goyan acknowledged that changing the generic approval system to incorporate USP would be a significant change in the system and a drastic response to the generic drug investigations. The former FDA commissioner contended that the system can be righted without overhaul. "It seems to me," Goyan said, "that only two things need to be done. First, you have to find a way to prevent substitution of the innovator product for the new generic product . . . And then we must take strong legal action against anybody who cheats." While the scandals and incidences of cheating by sponsors and favoritism by FDA reviewers are outrageous, Goyan said, the response of companies trying to discredit generic drugs has "to some degree amused, to some degree angered" him. "Those people who have always hated generic drugs have gone to what I consider a non sequitor from the fact that some people have been cheating on the process to the conclusion that the process is wrong." He particularly objected to the attacks on the use of bioequivalence tests to indicate therapeutic equivalence. In response to the position of the American Association of Family Physicians against generic use, he quipped: "I have been outrageous enough to have said that at least that group of physicians have proven that they know so little about drugs that they shouldn't be allowed to prescribe." Goyan reported that he had been approached by a group of West Coast physicians and pharmacists to sign the Aug. 23 petition to FDA to impose a moratorium on ANDA approvals ("The Pink Sheet" August 28, p. 7). He told the FDAers: "You need not look for my name on the petition."

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