If some sponsors are finding it more difficult than usual to schedule a meeting with FDA review staff on a new drug application, they are not alone. The agency has been denying more requests for meetings than usual lately as it adjusts to a heavier workload.

FDA has been forced to re-prioritize its drug review duties in light of new responsibilities, most significantly the implementation of the FDA Amendments Act and "Safety First" initiative (¹ Also see "FDA Puts “Safety First” For Post-Market Issues" - Pink Sheet, 27 February, 2008.). As a result, Office of New Drugs Director John Jenkins earlier this year advised review divisions that they are permitted to miss certain PDUFA product review deadlines in order to accomplish other tasks.

Despite progress in hiring new medical reviewers and the prospect of enhanced congressional appropriations, the agency may not be able to return to its historical user fee goal rates anytime soon.

During a "CDER Live" panel discussion at the Drug Information Association's annual meeting, the question of when FDA would be able to return to its regular review schedule was broached by industry representatives on several different occasions. At least by one account, the agency has denied requests for pre-IND and end-of-Phase II meetings - vital interactions with FDA reviewers for drug sponsors.

Jenkins acknowledged that his office was cutting back on certain meeting requests, noting that they tend to be quite labor intensive.

The number of meetings with FDA has risen exponentially in recent years, and a single meeting with a drug sponsor can be preceded with three or four internal "pre-meetings" among FDA officials.

"We're not ignoring those meeting requests; we're making strategic decisions about which ones we can grant and which ones we can't grant," Jenkins said.

Jenkins is not happy with the current situation but probably cannot do much about it. "Those meetings are valuable and very important," he acknowledged. "The IND part of our work is, in many ways, the most fascinating and stimulating part of our work, and we don't like that we have to cut back in those areas. But that's the reality."

That reality won't change until FDA can right its workload imbalance. "We have a lot more work on our plate than we have people in our building to help us get the work done. So we've had to make some prioritizations; we've had to make some decisions about what we can and cannot do," Jenkins said.

"Some of that has resulted in missing PDUFA goal dates. I cannot tell you when that will not be the case," he said. "It's going to change when we are able to recruit and staff and train so that we have adequate people to do the work that we have on our plate. I think that's going to take some time."

For drug sponsors, that means getting by with less advice from the agency - which could translated into lower-quality NDA submissions. For some idea as to how long it could be before things improve, consider this: It takes two to four years for FDA brass to train new reviewers.

-Kate Rawson (k.rawson@elsevier.com)

FDA Priority-Setting Includes Fewer Meetings With NDA Sponsors

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