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Executive Summary

Health and Human Services Secretary -designate, Louis Sullivan, MD, is promising Congress to give a high priority to problems at FDA of inadequate facilities and recruiting of medical officers. Sullivan was asked to comment on FDA during a round of hearings on the Hill prior to his confirmation. Sullivan acknowledged FDA's budget-related problems during a Feb. 27 appearance before the Senate Labor & Human Resources Committee. Following a statement on the issue by Sen. Hatch (R-Utah), Sullivan said: "I certainly agree with your premise that we need to strengthen the FDA and do everything possible to improve the efficiency of that agency." Sullivan cautioned that FDA improvements "have to face the realities of our budget constraints, but I do believe that this is something that demands high priority and I intend to give it high priority." Sullivan's nomination as HHS secretary was easily approved by the full Senate on March 1 in a 98-1 rollcall vote. The incoming secretary's official swearing-in is scheduled for March 10 in the HHS Hubert Humphrey building. Hatch, who is planning to introduce an FDA "revitalization" bill this month, reiterated his concerns about the agency at the hearing. FDA, he said, has "a terrific difficulty in maintaining skilled personnel; it is using antiquated equipment and its personnel are located in 23 sites around the Washington, D.C. area." Sullivan's appearance at Labor & Human Resources allowed him to get acquainted with the Senate panel whose oversight extends to HHS health care activities. The visit followed a relatively smooth confirmation process in the Senate Finance Committee on Feb. 23 ("The Pink Sheet" Feb. 27, p. 3). Sullivan, at Sen. Hatch's invitation, has agreed to tour FDA facilities with the Utah senator once he is sworn in as secretary. Hatch also extended an invitation to Labor & Resources Committee Chairman Kennedy (D-Mass.) to join the tour. Aside from the discussion with Sen. Hatch on issues relating to FDA, most of the discussion focused on issues raised earlier at the Finance Committee confirmation hearing. They included Sullivan's position on the President's proposed $ 5 bil. reduction in projected Medicare spending, the plight of rural hospitals under the current unequal Medicare reimbursment formula and Sullivan's position on abortion and fetal tissue research. Sen. Helms' (R-N.C.) was the only vote against Sullivan on the Senate floor. Sen. Mikulski (D-Md.) was not present. During debate prior to the vote, Helms said he was dissatisfied with Sullivan's failure to state a firm position on fetal tissue research. Sullivan has declined to take a definitive position on fetal research pending his review of a report by a special National Institutes of Health advisory panel. Separately, the White House announced two HHS appointments last week. As expected ("The Pink Sheet" Jan. 30, p. 4), Centers for Disease Control Director James Mason, MD, was appointed assistant secretary for health, and Constance Horner, director of the Office of Personnel Management, was named undersecretary at HHS. Mason will succeed Robert Windom as assistant secretary for health; Horner's new position was previously held by Don Newman.

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