FDA Misses User Fee Goals As Resources Tighten For Application Reviews, SPAs
Executive Summary
With the ink of the reauthorized Prescription Drug User Fee Act still drying, FDA is signaling that it may be some time before the agency will consistently meet the performance goals of its user fee program
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With the ink of the reauthorized Prescription Drug User Fee Act still drying, FDA is signaling that it may be some time before the agency will consistently meet the performance goals of its user fee program. Due to the confluence of increasing workload and understaffing, Office of New Drugs Director John Jenkins is granting explicit permission to CDER divisions to align their workload with their current capabilities, even if that means missing user fee goals. "In some cases we may have to cut back on work by declining requests from sponsors for guidance (e.g., meetings, multiple cycle ... reviews [of special protocol assessments]) and in other cases we may decide to go past the PDUFA goal date for review of an application," Jenkins wrote to "The Pink Sheet." Beyond its normal course of activities, FDA also is in the process of implementing the FDA Amendments Act and its Safety First/Safe Use program to manage post-approval drug safety activities with the rigor of pre-approval reviews (1 (Also see "Safety First: FDA Unveils New Postmarketing Management Process For Safety" - Pink Sheet, 3 Mar, 2008.), p. 4). These strains and ambitions will be among the management challenges for Janet Woodcock as she takes back the reigns at CDER (see 2 (Also see "Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss" - Pink Sheet, 17 Mar, 2008.)). In addition, CDER's primary functions have become increasingly burdensome in recent years, Jenkins notes. A Growing Burden "The workload growth has occurred in many areas, including the number of meetings conducted with sponsors, the number of special protocol assessments, work related to emerging safety issues and early communication, work related to responses to congressional inquiries, etc." Jenkins has previously observed that staff shortages were jeopardizing the agency's ability to meet PDUFA performance goals (3 (Also see "FDA PDUFA Performance Hampered By Inadequate Staffing – OND’s Jenkins" - Pink Sheet, 2 Oct, 2006.), p. 11). And at 550 full-time equivalents below its fiscal year 2008 ceiling, CDER can seemingly no longer accommodate the burden. The hiring challenges stem in part from the fact that the process is centralized at HHS (4 (Also see "FDA Staffing Problems Extend Beyond Funding Shortfalls; Culture Shift Sought" - Pink Sheet, 7 Jan, 2008.), p. 15). "We have actually failed to meet many PDUFA goals (e.g., goals related to meetings with sponsors) over the past few years, although we have generally been able to meet most of our application review goals," Jenkins notes. Many Kinds Of Targets To Aim For PDUFA creates a target for the agency to meet its deadline for reviews and other activities 90 percent of the time, but FDA has achieved 100 percent in many categories. However, in Fiscal 2005 FDA missed the review performance goal for priority applications, reviewing only 89 percent on time by coming in late on four applications. Generally over the past years, review performance of all types of applications has been in the "A" range, while the agency has struggled more in meeting the deadlines for other tasks (see chart: " 5 On Time In Hard Times: FDA's User Fee Goal Performance "). For 2008, FDA started the year by missing the user fee dates for a pair of antiarrhythmics: Astellas/Cardiome's Kynapid (vernakalant) and Solvay's Pulzium (tedisimil) (6 (Also see "The Year Ahead: Controversial NDAs Could Entangle FDA In ‘08; Where Are The Oncologics?" - Pink Sheet, 4 Feb, 2008.), p. 18). If CDER begins missing application review dates routinely, it would be very disruptive on the planning for the launch - the seminal event in the life of any product. But industry has been suffering the uncertainty of sliding deadlines in many of its interactions with the agency, and not knowing when a trial can start because of slow protocol review can be as troublesome as not knowing when an application review will end. In reauthorization negotiations for PDUFA IV, FDA emphasized the need for additional resources to conduct sponsor-requested meetings and special protocol assessments (7 (Also see "PDUFA IV: FDA Stresses Burden Of Industry Meetings In User Fee Discussions" - Pink Sheet, 21 Nov, 2005.), p. 3). The new program will provide FDA nearly $460 million, including significant resources for additional staff and FDA's IT infrastructure, to address the mounting workload. "No Specific End Date" Jenkins is not sanguine about when the impact of the increased funding will be felt. "We will be continuously assessing our workload and resources over time and make decisions on our priorities," he writes. "There is no specific end date since I cannot predict when our resources will be in balance with our work. That is why there is no blanket policy but rather permission to reduce work as needed on a case-by-case basis." Jenkins states that the center is "aggressively" seeking qualified candidates to build FDA's capacity, but he cautions that "it will take several years to achieve full staffing and to have all the new staff fully trained and productive." "In that interim, I have granted permission to the OND division and office directors to make decisions to bring their unit's workload into better balance with their existing resources. These decisions will be made on a case-by-case basis since the balance is not the same in all divisions or even the same over time in any given division," Jenkins writes. "In some cases we may not be able to meet PDUFA goals, and managers have been given the discretion to make those decisions." - Brian Marson ([email protected]) |