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EDWARDS COMMITTEE SHOULD ADVISE CONGRESS ON HODGE-PODGE OF FDA REFORM LEGISLATION, Ex-KENNEDY STAFFER HOROWITZ URGES; INTERIM REPORT IN SEPTEMBER

Executive Summary

The Edwards Committee would like to fend off pending piecemeal revisions of FDA's authority until an overview of the agency's mission can be completed. The committee considered asking Congress to hold off action on the pending assortment of FDA bills during the committee's July 12 meeting in Washington, D.C. Committee member Lawrence Horowitz, a former aide to Sen. Kennedy (D-Mass.) and currently an investment banker with James D. Wolfensohn, Inc., raised the issue of the committee's potential role in the current congressional efforts to expand FDA's responsibilities. Horowitz suggested that the panel help FDA by separating for Congress the pressing issues at the agency from the less timely subjects. Expansion of FDA regulatory authority in the cosmetics industry, for example, could be designated a back-burner issue, Horowitz observed. Rep. Wyden's (D-Ore.) Small Business/Regulation, Business Opportunities and Energy Subcommittee has been looking into the possibility of expanding the agency's regulatory authority in the cosmetics area. "Congress has to get, at some point, our feeling about priorities," Horowitz said. "Maybe, for example, with the problems facing FDA, as desirable as it might be, legislation broadening the [agency's] authority in the area of cosmetics ought to be put on the shelf for 'x' number of years until the rest are sorted out." Horowitz noted that in addition to legislation on cosmetics regulation, Congress is looking at expansive new medical device laws and at legislation that would endow FDA with new authority to impose sanctions for illegal activities in the generic drug and other industries. Frank Samuel, former president of the Health Industry Manufacturers Association, suggested that the committee also address how the agency handles its accountability to Congress. Alan Nelson, immediate past president of the American Medical Association, proposed that the group look at how the agency functions in repsonse to such external pressures. The comments from Horowitz, Samuel and Nelson were part of a committee discussion of the issues to be addressed in the group's interim report to HHS. A summary of committee observations or findings for the report was presented by committee Vice-Chairman James Grant, chairman and CEO, T-Cell Sciences (see box). According to a plan outlined by panel Chairman Charles Edwards, a draft of the report is expected to be circulated among members in late August and a final version will go to Secretary Sullivan in late September. In a presentation at the start of the July 12 session, Grant summarized the previous committee discussion and suggested for organizational topics. The first issue, Grant said, "is the issue of what I call a lack of leadership on the part of the agency...It's a question of creativity and vision, it's a question of the communication and motivation function and I think very importantly, leadership is what enables the FDA to attract the people it needs to do its job." The second issue is management, Grant said. Included in that is "a lack of strategic planning/priority-setting, lack of management systems" and "systems to improve people...questions of decision processes." Grant identified a third issue as "the need for independence on the part of the agency." He noted that "one can define independence from an organization standpoint...But the bottom line remains the same: independence is the key to the agency having status and stature; independence is what enables leadership or management to function; independence is what enables the agency to exercise its statutory authority." A final point for consideration is resources, he noted. The issue is "a tough one because there is no question that FDA stands in line with other very important agencies of the federal government [and]...if you look at the lack of adequate resources for the agency over the last several decades, there's no way that it can be corrected quickly." While it is an "important question," Grant noted that resources should take a back seat to the first three considerations. "It certainly makes no sense in my mind to think about resources unless you've got leadership, management and independence for the agency to do the job," he said. Grant added as a postscript that a related question, although "beyond our purview," is "how quickly the resources question can be at least temporarily alleviated. EDWARDS COMMITTEE OUTLINE OF KEY FDA ISSUES Issues to be expounded upon in interim committee report to HHS in September. Outline presented by committee Vice Chairman James Grant at panel's July 11-12 meeting. 1) "Lack" of leadership: "It's a question of creativity and vision; it's a question of the communication and motivation function...leadership is what enables the FDA to attract the people it needs to do the job. 2) Management: Including "a lack of strategic planning/priority-setting, lack of management systems [and] systems to improve people...questions of decision processes." 3) Independence: "The key to the agency having status and stature...enables leadership or management to function...enables the agency to exercise its statutory authority." 4) Resources: "It certainly makes no sense in my mind to think about resources unless you've got leadership, management, and independence."
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