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HHS POINT-BY-POINT RESPONSE TO EDWARDS COMMITTEE RECOMMENDATIONS REQUESTED BY SEN. KENNEDY; HHS SECRETARY SULLIVAN CALLS REPORT "BLUEPRINT" FOR FDA REFORM

Executive Summary

Sen. Kennedy (D-Mass.) has asked Health and Human Services Secretary Sullivan to provide a point-by-point response to each of the 29 recommendations made in the Edwards Committee's final report. "We will require of the secretary his positions on each of the recommendations," Kennedy said at the close of his committee's May 15 hearing on the Edwards Committee report. Although Sullivan addressed several of the points raised by the Edwards Committee at the hearing, Kennedy and Labor & Human Resources Committee ranking Republican Hatch (Utah) agreed that implementation of the recommendations might be accelerated if Sullivan were to respond in writing. Kennedy noted that under the British system, when a royal commission is established the government must give a response to each of the recommendations. He said that system seems to" be of some important value because too often we found out that commissions are established, testify and then the recommendations gather dust." Kennedy added that his committee" will take what legislative action is necessary to make sure that the . . . excellent recommendations have been implemented to the extent that we can"(see related story, p. 9). Sullivan called the report "a blueprint for appropriate reform" of FDA in accepting the report earlier on May 15 at the Edwards Committee's last meeting. In his testimony before the Senate Labor Committee, Sullivan praised the committee's work, calling it "outstanding." He added that he is "confident that this report will be considered a landmark document." Sullivan pledged to study the report "very carefully" and said he would "discuss the findings with my staff and with and with others in the private sector." He also noted that he has asked HHS Assistant Secretary for Health Mason "to work closely with [FDA Commissioner] Kessler to ensure that as many of the report recommendations as possible are implemented as expeditiously as possible." Sullivan added that he plans to work "very closely" with FDA Commissioner Kessler "to make sure that the FDA has the necessary financial resources and the necessary manpower." However, Sullivan stopped short of giving his unqualified support for the report's recommendations. "There may be a few recommendations, of course, that I would not support at this time or would not support without further information or evidence," Sullivan told the Senate committee. Committee Chairman Charles Edwards noted that "a lot of the implementation is going to have to come from the Secretary's office and I think that most of these things can be implemented in a short period of time." Sullivan expressed his opposition to only one of the Edwards Committee recommendations during the Senate hearing: that FDA be removed from the Public Health Service to streamline the regulations review process (see story, p. 9). The Secretary said that keeping FDA within PHS is important because of the agency's interactions with other PHS agencies, such as the National Institutes of Health. In his written testimony, Sullivan highlighted several of the Edwards Committee recommendations, including the FDA mission statement, management reorganization to clarify responsibilities and increase accountability, development of adequate management information systems, and enhanced enforcement tools. Sullivan also cited the report's recommendation that the balance between FDA responsibilities and available resources be improved as the basis for a personal plea to the Senate committee for support of FDA user fees. "I urge that you as members of the key Senate authorizing committee work closely with your colleagues on the Appropriations Committee to authorize FDA user fees as appropriate," Sullivan said. "Over the long term," he added, "user fees are an essential means of improving FDA's ability to fulfill new legislative requirements as well as its basic mission." The Edwards Committee report does not recommend user fees as a way to increase agency resources and is critical of the Adminstration's annual budgetary approach. Asked by Hatch if he supports the idea of a consolidated facility for FDA, Sullivan said he does and that he has "instructed Commissioner Kessler to proceed with planning for that, including investigation of possible sites for a consolidated facility." The Edwards Committee report emphasizes that FDA should not wait for a consolidated facility and that energy and resources should be focused on repairing rapidly deteriorating FDA facilities. Edwards said that consolidation would be "the ideal for FDA." However, he noted, "we think that a certain amount of action has to be taken immediately, and it isn't something that can wait a year or two years or three years." Sullivan reported that he intends to have Kessler "devise a priority plan for dealing with the repair and upgrading of certain facilities over the next five years, particularly in FDA's field offices around the country." Kennedy commented that Congress' enactment of the FDA Revitalization Act has not "caught the Administration's attention evidently because there was no request for any funding of that particular program" in the budget proposal for fiscal 1992. Hatch said he appreciates Sullivan's "enthusiastic support" for FDA revitalization and plant consolidation. However, Hatch added that "the message has to be carried to the Administration as well. They're just going to have to bite the bullet and find the funds to be able to do what has to be done out there." The Edwards Committee suggested that Kessler should consider appointing an independent manager to develop both short- and long- range plans for facility upgrading. The committee report notes that the commissioner should have the authority and funding to "develop better and more consolidated facilities, including the use of lease-purchase strategies."
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