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Executive Summary

FDA's fiscal year 1992 budget request of $ 770 mil. "positions us well" for the near term, FDA Commissioner Kessler told the House Appropriations/HHS Subcommittee April 18. Kessler reviewed the Bush Administration's budget request before the House panel and the next day before the Senate Appropriations/Agriculture Subcommittee. House subcommittee member Skeen (R-N.M.) asked whether the budget provides FDA with enough money to "do the job." Kessler replied: "I think the President's request for 1992 is a substantial request and positions us well for this coming year. I have some concerns about the long-term though." If "you look at the legislation that was passed last session," Kessler said, "I'm concerned about how those bills play out over two to three years." Over the long term, he suggested, "there is no other way to achieve [a] strong agency" without the kind of "infusion of funds that user fees would generate." The $ 770 mil. request includes $ 197 mil. in user fees, including $ 106 mil. from drug reviews and $ 36 mil. from biologics ("The Pink Sheet" Feb. 11, p. 3). HHS previously has cited the budgetary strain resulting from the 13 FDA-related laws Congress enacted last year, ranging from medical device amendments to revamping nutrition labeling. Kessler has to walk the tight wire of an administration official defending the budget request but also agreeing to more money if Congress is so inclined. The $ 770 mil. requested compares to a $ 690 mil. appropriations for FY 1991, which did not include user fees. The House passed a 1992 federal budget resolution April 17 suggesting a $ 50 mil. increase for FDA. House subcommittee Chairman Whitten (D-Miss.) pressed Kessler about how much funding was sought before FDA's budget was reviewed by upper levels of the Administration. Kessler acknowledged: "The original request was $ 982 mil." Last year, Congress agreed to the Administration's total request for FDA but provided the entire amount through appropriations. Under deficit reduction budget ceilings, Whitten remarked, "we have had a contest over who's going to get credit for these expenses. For the last number of years, we've had a reduced budget amount [submitted] but the proposal has user fees. But they can't get the Congress to pass the authorization for user fees." Rep. Durbin (D-Ill.) suggested there might be support for user fees "if it would be used to increase the number of employees and resources available to your agency." He commented: "When we receive the request from your agency suggesting that the Administration's user fess would generate some $ 197 mil., and yet the Administration is only asking for $ 79 mil. in new obligational authority, it more or less makes the case against user fees from the industry perspective." The user fee issue did not come up on the Senate side. In his opening remarks to both panels, Kessler noted that the funding increase would provide $ 35 mil. for increased payroll and operating expenses and $ 44.5 mil. for program expansions. New initiatives include an increase of $ 2.8 mil. to add 37 employees for AIDS drug and biologic product evaluations, an increase of $ 2.5 mil. in the generic drugs area "to hire 30 more specially trained criminal investigators," and an additional $ 3.1 mil. for generic drug review activities. The commissioner testified that as FDA "continues to be successful in its efforts to restore credibility and integrity in the generic human drug review process, it is expected that the influx of ANDAs and amendments will increase significantly. Twenty-two new chemical entities are due to come off patent by 1992 and we expect to generate at least 10 applications per entity" (see box). Before both subcommittees, Kessler stressed the two sides of FDA's product review responsibilities. While previously the focus was on keeping unsafe products off the market, there now is equal emphasis on getting safe products approved for marketing, he said. Responding to questioning from Rep. Kaptur (D-Ohio), Kessler said drug review times average about 30 months. "There's no question in my mind that that's still too long," Kessler said. Pointing to biotechnology, Kessler remarked that it "is a whole new industry where companies are dependent now on one product or a few products. They don't have the capital base to be able to wait 30 months." Discussing tacrine (Warner Lambert's Cognex) before the House panel and AIDS therapies with the Senate panel, Kessler said FDA is trying to "reach for the data" to help support product approval. After FDA's Peripheral & CNS Drugs Advisory Committee concluded in mid-March that it did not have the data to recommend approval of Cognex for Alzheimer's disease, FDA suggested one way to obtain data on efficacy questions would be through an expanded access program ("The Pink Sheet" March 25, p. 4). Kessler said: "If there is data that supports that this drug works in Alzheimer's disease -- and I think there are certainly those at the agency who believe that the drug has clinical activity -- we need to reach for that data. And I think that there is hope that an expanded access program could not only make it available [to patients] but equally important it would generate the kind of data" needed. Kessler's remarks followed questioning from Rep. Price (D- N.C.) for an update on the expanded access discussions and how many Alzheimer's patients are likely to be able to obtain the drug through the expanded access mechanism. FDA Office of Drug Evaluation II Deputy Director Bruce Burlington informed the panel that those answers still are "being worked on in negotiations with the sponsor." Chart omitted.

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