FDA,FY 2000 Performance Report for the Prescription Drug User Fee Act of 1992,PDUFA Main Page

FY 2000 Performance Report to Congress

for the

Prescription Drug User Fee Act of 1992

as reauthorized and amended by the

Food and Drug Administration Modernization Act of 1997

Food and Drug Administration, Department of Health and Human Services

Commissioner's Report

In 1992 Congress enacted the Prescription Drug User Fee Act (PDUFA), a five-year program that provided FDA with additional resources to hire more medical and scientific reviewers to conduct premarket reviews, as well as support staff and field investigators. FDA committed, in connection with the 1992 legislation, to meet a set of review goals that would become more stringent each year. PDUFA enabled FDA to collect user fees from the industry to make achieving these goals possible. FDA was and is expected to apply the same high standards -- indeed, the gold standard for the world -- for safety and efficacy evaluation for those products that would enter the marketplace. The results of this initial experiment were reviewed in 1997. The results demonstrated clearly that, with adequate resources, FDA is capable of meeting the most demanding of performance standards. Thus, in 1997, Congress authorized PDUFA for another five years.

With this authorization came additional resources, but higher expectations for reviews, and additional goals related to FDA's responsiveness to industry during the early periods of drug development. In the first three years of PDUFA II, the Agency has met, with rare exception, all of the performance goal. We can now confidently state that these results provide evidence that we are far beyond the experimental testing phase. Nevertheless, under the sunset provisions of the Congressional authorization, further legislative action will be necessary if FDA is to maintain the authority to collect user fee revenue beyond FY 2002.

While premarket review is a critical piece in the risk assessment and management of medical products, it cannot, and should not, be seen in isolation. FDA is committed to the lifetime of the product, not just from the early stages of drug development through review and approval, but also to monitoring the products once they reach the marketplace. The post-approval areas are just as critical to assuring the safety of a product over its lifetime of use. One such area is adverse event reporting -- a process that allows us to discover previously undetected, and unexpected, adverse reactions to products after marketing. This is a key area since, prior to approval for marketing, most drugs are exposed to only a relatively small population in a controlled environment.

As we begin working with the industry, the Congress, and our stakeholders to forge PDUFA III, I want to assure the American people that FDA's overriding goal in this area is, as it has been, to bring the benefits of effective new products to the market as quickly as possible without compromising the high safety standards the American people expect.

Jane Henney, M.D.
Commissioner of Food and Drugs