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HHS' MASON SAYS SOME FDA POWERS SHOULD BE RESTORED, BUT OPPOSES INDEPENDENCE; FDA WILL NOT PLAY BUDGET "SHELL GAME" TO IMPLEMENT NEW LAWS

Executive Summary

Some FDA authorities that were transferred to HHS or the White House Office of Management and Budget over the past several years should be returned to the FDA commissioner, HHS Assistant Secretary for Health Mason told the Edwards Committee "blue ribbon" panel on FDA Dec. 17. At the same time, Mason rejected the notion of making FDA an independent agency, on the basis that such a move would harm the symbiotic science network of the Public Health Service. Mason indicated these beliefs were strengthened during his tenure as chairman of a panel convened to review the functions and status of another PHS component, the National Institutes of Health. As a result of the NIH panel's recommendations, Mason said, "certain authorities are being delegated from the Secretary's office to me and I, in turn, am delegating those to NIH. And I think one would have to look at a similar look-see with regard to personnel, with regard to advisory committee selection and things of that nature" for FDA. Mason said: "One of the easiest things to do from what people said in my experience . . . was 'let's elevate'" the agency to be independent. On fuller consideration, he noted, the real question for either NIH or FDA is the same: "How do we, within the structure of the PHS and the department, provide the commissioner with those authorities that are needed to get the job done?" Mason opened his presentation by saying: "I believe that the Food and Drug Administration can function most effectively as part of the United States Public Health Service." Moving FDA would weaken both that agency and the PHS, would "seriously compromise the cooperative and collaborative efforts invested by the PHS agencies in the interest of public health," and would lead to a "fragmentation" of health policy, he asserted. Such a move also would cause FDA to be viewed "more as a regulatory agency without the public health conviction and scientific research components that are crucial for providing the basis for sound regulation." At the committee's closing discussion on Dec. 18, Chairman Charles Edwards, MD, said that the redelegation of authority issue would have "first emphasis" at the committee's next meeting, Jan. 23-24 in San Francisco. Second on the agenda is the FDA commissioner's "reporting relationship" to the HHS secretary and third is defining a position on independence. Edwards remarked: "I think that the greatest favor we could do to the Secretary and certainly more specifically to the new commissioner is to get the redelegation of authority." Independence, however, is a "highly, highly explosive" and political issue, and is an approach "that might in the final analysis cause more problems then it could ever solve," he said. Assistant Secretary Mason also strongly criticized congressional action last year to enact 14 FDA-related laws but provide no additional money for their implementation. "I'm not going to ask [FDA commissioner] David Kessler to implement any one of those . . . statutes that passed unless he has resources to do it and we will go on notice with a memo from me to the Secretary saying" we need "resources, we need FTEs [full-time equivalent staff positions] or we can't implement this law." He particularly cited FDA's likely inability to implement the Safe Medical Devices Act of 1990 without adequate resources and more personnel. Implementation will cost "many millions of dollars in fiscal year 1991 and that burden will even be greater as you . . . go into 1992," he warned. Mason said FDA is "spread so thin, the only way you could implement that piece of legislation is to play the same shell game that has been played in the past, and I just don't believe we can let that happen." However, Senate Labor and Human Resources Committee Ranking Republican Hatch's (Utah) staff assistant, Nancy Taylor, told the Edwards committee's subcommittee on medical devices and biomedical research Nov. 13 that Hatch would consider proposing additional funding if needed to implement the device law changes.
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