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The Future of Drug Safety: Promoting and Protecting the Health of the Public
Mass media coverage of perceived organizational problems in CDER has been frequent and detailed, for example, describing an apparent lack of mutual respect and tension between preapproval review staff and postmarketing safety staff, and a work environment thought to be marginalizing dissenting voices on drug safety (Mathews, November 10, 2004; Harris, February 20, 2005; Henderson, December 6, 2005). As questions about culpability mounted, a series of organizational and programmatic problems in the center highlighted in the mass media were also examined in government reports, including the reports of the DHHS Inspector General that surveyed CDER staff (DHHS/OIG, 2003) and reviewed the state of postmarketing commitments (DHHS/OIG, 2006), respectively, and the reports of the Government Accountability Office that assessed the impact of the Prescription Drug User Fee Act (PDUFA) on CDER staff’s morale and workload (GAO, 2002) and examined the structure and effectiveness of CDER postmarketing decision-making processes (GAO, 2006). Many observe signs of an organizational culture in crisis. It has also become apparent that drug safety events, whether indicative of or associated with organizational and cultural problems, have led to diminished agency credibility among the public. Drug safety experts, members of Congress (including Senators Michael Enzi, Edward Kennedy, and Charles Grassley, and Representatives Rosa DeLauro and Maurice Hinchey), consumer organizations (such as Consumers Union, Public Interest Research Group, the National Consumers League, Public Citizen), and others have called for organizational, statutory, and resource changes in the agency. Proposals have included restructuring the agency to segregate the drug review and postmarketing safety functions by creating an independent drug safety center (Fontanarosa et al., 2004; Consumers Union, 2005; Grassley, 2005; Ray and Stein, 2006; Wolfe S, 2006). FDA itself has undertaken a series of initiatives and changes, described in detail in Appendix A, including the commissioning of this Institute of Medicine report (see discussion in Chapter 1) (Crawford, 2004; Wall Street Journal and Harris Interactive, 2006).
In its discussions with current and recent FDA staff and managers (see Box 3-1), and on the basis of its review of relevant government reports, the committee found that the organizational culture in CDER confirms some of the adverse perceptions conveyed in the mass media, and that the center is an organization in urgent need of great change.
The committee found that CDER’s organizational culture has both strengths and weaknesses. The positives are that science-based decision making is a clear priority that shapes CDER’s culture, as does the staff’s obvious awareness of the potential consequences of their decisions on the health of the public and individual patients. The negative features of the culture include a work environment that is not sufficiently supportive of staff (as evident in problems with morale and attrition), polarization between