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Executive Summary

FDA may develop a NDA resource management system to improve the planning and scheduling of NDA reviews and thus avoid unnecessary delays, Commissioner Kessler said at a July 25 hearing of the Senate Governmental Affairs Committee. Kessler and Center for Drug Evaluation & Research Director Carl Peck, MD, "are beginning to identify initiatives to improve the drug review process," the commissioner explained. "For example, I hope to develop a resource planning and scheduling system which will allow the [new drug review] division directors to define critical timeframes and to schedule resources to avoid bottlenecks," he said. Under the concept, the entire center would track its activities so that review timeframes are met. The commissioner was updating the committee on FDA's efforts to enhance its product review efficiency and to streamline and strengthen its enforcement actions. Chairman Glenn (D-Ohio) called the hearing to discuss the HHS (Edwards) Advisory Committee's report, which said FDA illustrates the "hollow" regulation by underfunded federal agencies. Kessler also announced that FDA has "set a goal of automating all NDA reviews by 1995." Noting that the agency is continuing its "very promising pilot test" of computer-assisted NDAs (CANDAs), the commissioner said analogous uses of automated marketing applications are being explored in the agency's other centers. Glenn closely questioned Kessler about how FDA's funding requests have fared in the Bush Administration. The Ohio Democrat noted that FDA's original request for fiscal 1992 funding was $ 987 mil. but was eventually scaled back to $ 770 mil., $ 196 mil. of which was proposed to come from user fees rather than appropriations. Repeating a phrase he used at Rep. Waxman's (D-Calif.) recent House Health Subcommittee hearing on FDA enforcement legislation ("The Pink Sheet" July 22, p. 7), Kessler replied that the Administration ought to "speak with one voice." The commissioner explained that "I need to deal with what I control." But he emphasized that the $ 770 mil. spending level in the President's budget request "is very important for us." When Glenn again emphasized the $ 987 mil. original request, Kessler suggested that the current focus should be on the $ 770 mil. goal. Congress is likely to appropriate an amount between the Senate proposal of $ 738.7 mil. and the House proposal of $ 761.9 mil. (see related story, T&G-1). Turning to the length of time FDA has taken to issue regulations, Glenn asked if delays have been caused by layers of review higher in the Administration. Kessler again avoided pointing his finger at the hierarchy of the Administration, but said instead that the "problem lies . . . with the agency itself." Noting that his statement is "not a popular answer within the agency," Kessler said that when he came to FDA he found that no one had tracked and held responsibility for implementing regulations. One function of the deputy commissioner for policy -- a position Kessler is establishing -- will be "ensuring that new regulations are written and issued promptly," the commissioner said. Michael Taylor is expected to join the agency shortly in that post. Pharmaceutical Manufacturers Association President Gerald Mossinghoff testified that FDA should establish a tracking system so that the status of pending INDs and NDAs can be ascertained. A tracking system also will make it "possible to have better measures of [FDA reviewer] performance and to identify obstacles," Mossinghoff said. Noting that CDER "has made significant progress in tracking the IND and NDA workload," he urged that such efforts "be continued, enhanced and generalized to the biologics component of the agency."

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