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FY 2002 Performance Report to Congressfor the Prescription Drug User Fee Act of 1992as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997Food and Drug Administration Commissioner's ReportI am pleased to submit the Food and Drug Administration's (FDA's) FY 2002 Performance Report to Congress for the Prescription Drug User Fee Act (PDUFA). All of the original applications submitted during FY 2001 have been reviewed and acted upon and final performance data can now be reported. Only a preliminary performance assessment on applications submitted during FY 2002 is possible at this time. During FY 2001, FDA met and in many cases exceeded our PDUFA performance goals. Since Congress first authorized user fees for new drug review in 1992, FDA has consistently met increasingly tougher PDUFA performance goals. As a result, patients are getting the benefit of new drugs more quickly. As the Tufts Center for the Study of Drug Development said near the end of PDUFA II, "The change in the environment for pharmaceutical innovation in the United States that has occurred since passage of PDUFA has been nothing short of remarkable." Last year Congress renewed the program for another five years as PDUFA III to continue and build on FDA's success. Agency-wide initiatives to speed development of new medical technologies will be a major thrust in FDA's new strategic plan. During calendar year 2002, FDA approved a large number of new products, many of which represent significant advances for patients and physicians by providing new options to treat serious, disabling, or life threatening diseases. Counterbalancing this positive news from 2002 are some trends showing decreases in the submission of new applications for truly innovative new products. The trend of declining numbers of these 'new' products presents a challenge to both industry product developers and to FDA, whose mission includes increasing patient access to safe and effective new products. FDA has committed to achieving measurable long-term improvements in disease outcomes; this can only be accomplished by enabling successful new technology development. Performance in terms of approval times for drugs and biologics approved in calendar year 2002 was mixed, with some decreasing and some increasing. FDA is focusing on reducing the longer approval times that result from multiple review cycles where additional information is needed before an application is approved. There may be steps that FDA can take to help product sponsors submit applications that "get it right the first time," providing the safety and effectiveness data required for approval without the cost and effort of multiple review cycles. FDA plans to take steps to address both the longer times to approval and the lower numbers of applications for truly new and innovative products. We recently announced initiatives to reduce the total time and cost of developing and approving safe and effective new products. The initiatives fall into three categories:
These initiatives do not represent fundamental changes in the way we do business. Rather, they build on initiatives that FDA has already tested or implemented successfully. All are focused on making sure that our expert reviewers have the best support possible so they can review applications quickly and efficiently, and thus speed new medical products to American patients and practitioners without sacrificing FDA's traditionally high standards for safety and effectiveness. Mark B. McClellan, M.D., Ph.D. | |
FDA/Office of Planning |
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