2005–2006; Union of Concerned Scientists, 2006) based on real or perceived “capture” of the agency, that is, that the center’s increasing dependence on industry funding in itself creates a sense of obligation “to please” on the part of the agency. The Pharmaceutical Research and Manufacturers of America (PhRMA) itself has expressed a concern about this perception.

“We share a concern with FDA about the current balance between the user fee portion and the appropriated portion of the review process,” PhRMA’s Goldhammer says. As industry funding approaches half of the review budget, “it has led to a perceptual issue that industry is paying for the review process and that the American public, through its tax moneys, is not. We would hope that can be dealt with in some way because we don’t want there to be the perception that this is an industry-driven program” (Thompson, 2000).


The effects of user-fee funding are experienced differently by different staff at CDER (IOM Staff Notes, 2005–2006). Some staff recognize no impact on their day-to-day work of the source of their salary and support the principle and practice of the user-fee system, while others expressed concerns about the workload and time pressures that they feel have accompanied the PDUFA funding,2 cognizant that if industry were displeased with CDER performance and worked to eliminate user fees (and appropriations did not increase to close the shortfall), staff would have to be eliminated. Yet other CDER staff, particularly CDER leadership and managers, describe PDUFA as setting necessary performance goals that any responsible agency should employ regardless of links to funding source, and deny that the goals are used as anything more than targets. Indeed, the goals allow for review times longer than the 6- and 10-month approval targets in up to 10 percent of the cases for standard-rated and priority-rated new drug applications. However, if CDER were to consistently miss the goals for time-to-approval, the pharmaceutical industry would push for changes in PDUFA fees or other arrangements in the following round of negotiations. This reality would undoubtedly put pressure on CDER management to meet these targets.

For some staff and policy analysts, user-fee funding, combined with industry’s considerable role in shaping PDUFA-associated goals and expectations, further reinforces the perception that the industry has become a primary driver of the agency’s priorities and performance.3 The notion

2

As described in Chapter 2, some CDER new drug review staff assert that the workload pressures to meet PDUFA goals are compounded by industry submissions that are not well organized, submissions that come in on paper or with data that are not easily reanalyzed, or on suboptimal management by their direct supervisors or team leaders. Some of these CDER staff also reported that the biggest pressures come from 6-month priority approvals and not from standard applications, the goal for which is 10 months for approval.

3

Zelenay has proposed eliminating the PDUFA sunset clause as a means to reduce the industry’s bargaining power (Zelenay, 2005).



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