FDA gets OK to blow PDUFA deadlines

The FDA’s director of new drugs, John Jenkins, has told his reviewers that they may miss Prescription Drug User Fee Act (PDUFA) deadlines by up to two months and decline some sponsor meeting requests, among other steps to manage workload and staff shortages. The permission was given in an internal memo.

“We have always had discretion to miss PDUFA goals for legitimate reasons,” he said, pointing out that none of those goals are higher than 90%. “We have been missing procedural and processing PDUFA goals (e.g., meeting management goals) for the past few years, since the workload exceeded our capacity, but have mostly met our application review goals.” 

Jenkins emphasized that decisions to miss goals will be made by OND management and not by individual reviewers, “with specific justifications based on workload, resources, competing priorities and these decisions will occur on a case-by-case basis, there is no blanket policy to miss or extend all goals. We remain committed to meeting our PDUFA goals whenever possible.”

He said sponsors will be notified if his office is unable to grant a meeting request or needs to miss a PDUFA goal.

The workload crunch has come about because CDER is currently 550 FTEs below its FY ’08 ceiling and is struggling to meet existing workload and the new expectations of last year’s FDA Amendments Act as well as the new Safety First/Safe Use initiative announced in February.

“We are doing all we can to recruit new staff,” Jenkins told us, “but are hampered by slowness of the government personnel system, the need to select qualified candidates, and salaries that… are not competitive with the private sector. We are offering recruitment incentives including signing bonuses, relocation expenses, and student loan repayment. We are also offering referral bonuses for current staff who refer a candidate who accepts a job offer with FDA.”

Jenskins said it can take 1-3 years to train new employees, so recruitment and training does not occur swiftly.