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Executive Summary

HHS HEALTH CHIEF NOMINEE WINDOM OPPOSES AMENDMENT TO REQUIRE FDA commissioner confirmation by the U.S. Senate. The Administration's nominee for assistant secretary for health testified at a June 5 confirmation hearing before the Senate Labor & Human Resources Cmte. Because the amendment, which is contained in the Senate-passed Drug Export Bill, would make the FDA commissioner directly responsible to the HHS secretary rather than to the assistant secretary for health, Robert Windom said it "would lessen the opportunity to get all together these various [Public Health Service] agencies to work most effectively." Cmte. Chairman Hatch (R-Utah), the Senate sponsor of the export bill, asked Windom to state his position on making the commissioner post a presidential appointment subject to Senate confirmation. Windom replied: "I think the commissioner of the FDA does a very excellent job, but I think the coordination of the FDA along with other agencies under the aegis of the assistant secretary of health is the most efficient way to operate because so many of our activities are" interrelated. Windon, 56, is a physician who practices in Sarasota, Fla. and is a professor of internal medicine at the University of Miami and the University of South Florida. The Hatch cmte. is expected to forward his nomination on June 18 to the full Senate. Regarding the Administration's proposal to permit FDA to charge and retain user fees for FDA review of new drug applications, Windom said such charges would provide "some formal support . . . with nontax dollars" for the people, equipment, and training necessary for drugs to "progress more rapidly through the [approval] process." He noted that "many people in the communities of medicine and science" ask why drugs "available elsewhere in the world . . . are not available more quickly here," and the answer is that "there have been limitations placed upon" FDA resources. In a prepared statement, the cmte.'s Ranking Minority Member Kennedy (D-Mass.) questioned the nominee's "formal qualifications" for the HHS health post. "All of the previous appointments to this position have had strong records as biomedical research scientists, have directed important academic medical centers or major research institutes, or have previously held [a] responsible federal health position," Kennedy noted. "By contrast, Dr. Windom has met none of these important benchmarks that have been applied to previous appointees. He has been active in medical affairs in Florida, he has served as a member of public health-oriented voluntary agencies and advisory cmtes., and he has given large amounts of money to Republican candidates for office," Kennedy said. Windom donated $55,000 to the Republican Senatorial Trust from 1977-1986. Nonetheless, Kennedy told the nominee: "I expect that you're going to be confirmed, and I want to have the opportunity of working with you."

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