Thursday, June 26, 2008

FDA and Review Meetings: Getting By With Less Advice

If you are having more trouble than usual trying to schedule a meeting with FDA review staff on a new drug application, you’re not alone. The agency has been denying more requests for meetings as it adjusts to a heavier workload.

And it’s not going to get better anytime soon.

As we’ve reported previously, 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. As a result, Office of New Drugs director John Jenkins has directed his review divisions to miss certain deadlines set up by the user fee program in order to accomplish other tasks.

With all the progress FDA has made in hiring new medical reviewers and the recent bolus of new cash from Congress, you might think the agency would be able to return to its historical Prescription Drug User Fee Act (PDUFA) goal rates soon—if not already. Unfortunately for drug sponsors, they're not even close.

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 PDUFA review schedule was broached by industry representatives on several different occasions. At least by one account, the extra work has led the agency to deny 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. (Meetings with FDA have 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 isn't happy about the current situation, but there isn't much he can do about it. “Those meetings are valuable and very important,” he said. “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—and that means 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.

And you thought approval rates were low now.

(Photo courtesy of Flickr user bhell13 via a creative commons license.)

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