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FDA MANAGEMENT SYSTEMS IMPROVEMENT WOULD BE FIRST PRIORITY FOR UPJOHN’s NOVITCH IF HE WERE FDA COMMISSIONER AGAIN, EXEC TOLD BLUE RIBBON PANEL

Executive Summary

Improved FDA management information systems would be the first priority for Upjohn Exec VP Mark Novitch, MD. At the July 11-12 meeting of the FDA blue ribbon (Edwards) committee, Novitch was asked where he would start if he were appointed commissioner. Novitch responded: "I would want management information systems [and] I would want systems for accountability." Novitch, who was a key FDA manager during the 1970s and an acting commissioner during the transition between the Carter and Reagan Administrations, said that FDA's management information, field information, communications and data handling systems "all badly need modernization and integration." He added that FDA "needs to improve long-term strategic planning [that] would set agency priorities, reflect anticipated workloads, [and] measure the level of effort assigned to various activities." Panel member Jane Delgado, PhD, president and CEO, National Coalition of Hispanic Health and Human Services Organizations, posed the "what if" question to Novitch and two other guest panelists: Peter Barton Hutt, a former FDA chief counsel and currently a partner with the Washington, D.C. law firm Covington & Burling, and William Schultz, formerly with Public Citizen's Litigation Group and currently counsel for Rep. Waxman's (D-Calif.) House Energy & Commerce/Health Subcommittee. If he were commissioner, Novitch said that he would talk with Congress, the Department of Health and Human Services Secretary, the Office of Management and Budget, and the Public Health Service to discuss their relationship with FDA. Novitch would try and establish independence for the agency, first by redelegating to FDA "the authority to issue rules without prior approval by" the other agencies (see related story p. 6). Lastly, Novitch stated that he would not ask for, but "demand the resources that we need, the facilities, the manpower, the funding that we need to get this agency moving." Similar to Novitch's plan, Hutt said one of his top two objectives at the agency would be to set "priorities and a management system to make sure that they work." Regarding authority over FDA, Hutt said he would try "to work out an accommodation with HHS and OMB." The first thing Hutt would do "is set up a recruitment system." He said that "it appears to me that FDA has been almost bled to death in terms of people in the past decade. Some of the best and brightest have left the agency." The comments of previous high FDA officials on the management challenges at the agency may be particularly noteworthy because one of the top candidates to be the next commissioner sits on the Edwards Committee: David Kessler, medical director at the Albert Einstein College. In one sense, the July 11 session can be viewed as a graduate seminar on the burdens and priorities for FDA management. Despite his interest in recruitment, Hutt discounts the importance of one of the agency's current key recruiting lures -- the opportunity to stay involved in basic research. The former FDA general counsel suggested that the agency drop research activities that do not pertain to its compliance role. Hutt suggested using other agencies for research and using "FDA for the real hard line law enforcement and consumer protection, because no one else does that." In response, panel member Rita Colwell, PhD, director, Maryland Biotechnology Institute, noted that students she has talked with "don't like to go to places where they can't do at least some sort of creative research. And there are some components of FDA to which they're attracted, because they have the opportunity, and there are other components of FDA which they wouldn't touch with a 10-foot pole." In a July 9 letter to Committee Chairman Charles Edwards, Acting Commissioner Benson emphasized the importance of FDA's applied research programs. "FDA could not make informed regulatory decisions, nor could it remain adequately informed on current safety and health issues, without an active scientific staff," Benson said. "It is...essential that FDA's research is at a level sufficient to keep our scientists current with techniques leading to the development of current and near-future products." Benson's letter responds to questions raised by the committee at its initial meeting. Before taking the commissioner job, congressional staffer Schultz said he would "work out this HHS/OMB problem" preferably by making FDA an independent agency. Secondly, he would "get a list of every pending regulation and devise a scheme for getting regulations promulgated within a year." As a third mission, Schultz would strengthen FDA's enforcement capability. During a presentation to the committee, General Accounting Office Assistant Comptroller General Lawrence Thompson said that GAO believes it is time to conduct an agency-wide review of FDA's management. GAO evaluations of specific FDA programs have uncovered problems that "suggest agency-wide management areas that may need attention," he said. These areas include strategic planning, performance monitoring, human resource management, and management information systems. According to Thompson, GAO has discussed the idea with FDA for the past six to eight weeks. However, FDA has not reached a final decision. The blue ribbon panel, Thompson said, "can give guidance to the agency on how to prioritize its work and guidance to the Congress on the scope of FDA's responsibilities and the adequacy of its legislative mandates. If we work through a management review, we can help the agency further develop these management systems that are needed by FDA to fulfill the mission that you define." With one exception, GAO's September 1989 report on FDA resource planning, "GAO has not focused on management activities that cut across FDA programs," Thompson noted. "Unlike most of our GAO evaluations, these [general management] reviews are usually initiated by us rather than by Congress, and depend very much on the cooperation and support of the agency heads."
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