with a view to identify areas of vulnerability and facets of the system that could be strengthened in order to improve its overall functioning in meeting the needs of the American public.
Complaints about delayed patient access to drugs already approved in other countries and the AIDS advocacy movement of the 1980s are considered among the major factors that motivated legislative action to speed up FDA’s drug approval process. However, criticism of the pace of drug approval may be traced to the early 1970s. At that time, pharmaceutical companies, scientists, and consumer organizations argued that the 1962 Drug Amendments to the Food, Drug, and Cosmetic Act, intended to strengthen the drug approval process by requiring that sponsors demonstrate efficacy, also stifled drug development and delayed drug approval (DHEW, 1977). In the 1990s, FDA attributed the delays to shortages of staff and computers (FDA, 2005b). Concern about the slow pace of drug review finally led to PDUFA.
The enactment of PDUFA in 1992 resulted from a potent combination of interests. Patient advocacy groups called for faster access to promising therapies, the industry desired a more efficient regulatory process to enable faster marketing of new drugs and a longer patent life, FDA needed more resources to expand its review staff to meet demand for greater regulatory expediency, and some members of Congress were concerned that new drug approvals in the United States lagged behind those of comparable European nations. With congressional oversight and input, PDUFA was enacted with the goal of meeting the needs of FDA, industry, and patients. Although the 1992 PDUFA succeeded greatly in decreasing review times (FDA, 2005b), its first two iterations (PDUFA I in 1992 and PDUFA II in 1997, see below) specifically prohibited the use of fees for any postmarketing drug safety activities. Also, the speeding up of the review process highlighted potential weaknesses and limited capability in the area of postmarketing safety. By the latter part of the 1990s, various observers, including consumer groups and researchers, became concerned that the increased pace of drug approvals had unintentionally led to a neglect of—or at least insufficient attention to—safety considerations, resulting in what was seen as a greater rate of drug withdrawals (Lurie and Wolfe, 1988; Hart, 1999; Tone, 1999). Numerous journal editorials and articles by scientists, consumer advocates, and agency leadership continued the dialogue (Kleinke and Gottlieb, 1998; Wood et al., 1998; Friedman et al., 1999; Landow, 1999; Lurie and Sasich, 1999). In response to mounting unease, FDA Commissioner Jane Henney convened “a Task Force to evaluate the system for managing the risks of FDA-approved medical products” (DHHS/FDA, May 1999). Although the task force found that rates of withdrawals were low (the limitations of treating withdrawals as a safety metric are discussed below), the group identified process, resource, and statutory constraints on FDA’s ability to