by regulatory scholars (such as Stigler, 1971) to describe successful industry pressure on regulators, and some observers actually believe that PDUFA has facilitated the capture of FDA. The core problem in the relationship between industry and FDA (leading FDA to consider industry a client) may lie in the power of the industry to shape the scope and nature of PDUFA goals (Olson, 2002; Carpenter et al., 2003; DHHS and FDA, 2005; Okie, 2005). In the negotiations between FDA and the industry, Congress has given the industry a considerable role in influencing what activities the user fees will fund, thus limiting regulatory discretion and independence. In particular, fee revenues only could be used to support activities designed to increase the speed and efficiency of the initial review process. Fee revenues could not be used to support postmarketing safety surveillance from 1992 to 2002. In the 2002 PDUFA reauthorization, a small amount of fee revenues (about 5 percent) was permitted to be used for postmarketing drug safety activities; however, restrictions on when these funds could be spent (only for drugs approved after 2002, and for up to 2 years after approval, or up to 3 years for “potentially serious drugs”) limited their effectiveness (Zelenay, 2005). In Chapter 7, the committee discusses this troubling feature of PDUFA and suggests an alternative.

Concerns about inappropriate influence on regulatory decision making are not new, although it can be argued that PDUFA has made the connection between CDER performance and industry expectations much more explicit. In 1977, a government panel examined whether there was pressure on reviewers of new drugs to make regulatory recommendations favorable to the industry (DHEW3 Review Panel on New Drug Regulation, 1977; DHEW, 1977). The panel concluded that the problem was largely linked to poor management rather than verifiable industry influence.

The second basic issue explored by the Panel was whether industry exerts undue influence on FDA decisions. Many current and former FDA employees and consultants had testified to Congressional committees that industry pressure caused FDA officials to approve drugs that did not meet agency safety and effectiveness standards and that those who attempted to oppose industry demands were harshly and improperly treated by senior FDA officials. From detailed investigations of these allegations by its staff, the Panel concluded that there was no widespread use of improper influence by industry representatives. It did identify several instances in which FDA supervisors unfairly disciplined dissenting employees, but these lapses were found to result from poor management rather than improper efforts of industry to control agency decision-making [Dorsen and Miller, 1979:910].

3

Department of Health, Education, and Welfare, predecessor of the DHHS.



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