Providing a new target decision date in tandem with missing a user fee review deadline would help FDA restore credibility and predictability to the review process, former FDA official Bruce Burlington suggests.

Now an independent consultant, Burlington worked for FDA before leaving in 1999 to head regulatory affairs for Wyeth. He addressed the issue during a panel discussion at FDC-Windhover's FDA/CMS Summit.

Resource constraints and competing priorities have led to an increase in missed review deadlines - missed deadlines sanctioned by Office of New Drugs Director John Jenkins in a memo to his review divisions earlier this year (¹ Also see "FDA Misses User Fee Goals As Resources Tighten For Application Reviews, SPAs" - Pink Sheet, 17 March, 2008., p. 11).

Many of those missed review deadlines have translated into a brief wait and then approval, but there have been other cases where applications are left in limbo for months (² The RPM Report, August 2008).

It is especially those situations that demand better communication, Burlington said. Some divisions are doing so, but it is not consistent across OND.

"There has been a fair amount of splay with what happens subsequent to a missed deadline," he said. "It would be very helpful that if there was a compelling reason that a deadline has to be missed - like if an advisory committee couldn't be scheduled on time - that there were a new commitment or action date shared with the company and made publicly available."

So far this year, only a handful of new product applications have gone past their review deadline. Between Jan. 1, 2008 and Oct. 31, 2008, FDA missed 32 review deadlines for new drug or biologic applications (20 percent) and 19 efficacy supplement reviews (10 percent), according to data presented by Jenkins (see chart: " ³ FDA's Drug Review Report Card ").

Based on data so far, FDA has met its 90 percent obligation for efficacy supplement reviews under the Prescription Drug User Fee Act. For new product reviews, the number is a bit lower than in recent years, when on-time rates were at or well above 90 percent.

Jenkins believes those data should be looked at optimistically. "We don't let [missed applications] fall off our radar screen forever. They do get acted on, and the approval percentage is in many ways not different than the approval percentage for things that meet their goal dates. ... All is not lost."

But those percentages also assume that FDA meets every one of its review deadlines for the final three months of the year. Given that many applications tend to come due in the latter part of each calendar year, it will be a challenge to match that standard.

Burlington was encouraged by Jenkins' numbers, but cautioned that they do not tell the whole story. "The data available to analyze FDA's performance are inherently lagging a few years," he noted. "There is some reassurance in the presentation ... On the other hand, I don't think it has squarely addressed the question of 'have things gotten tougher over the last year,' which is what a lot of us have been worried about."

Cleveland Clinic cardiologist Steve Nissen - who is certainly not a fan of the Prescription Drug User Fee Act - also criticized the missed review deadlines, saying that FDA is not meeting its end of the bargain on PDUFA (⁴ Also see "Industry Pays Fees, FDA Should Deliver, Nissen Says Of Missed PDUFA Dates" - Pink Sheet, 8 December, 2008., p. 3).

But Patrick Ronan, a former FDA chief of staff who is the founder of the consulting firm Greenleaf Health, expressed much more optimism. "When you look at everything the FDA has on its plate right now...it becomes understandable why we've seen review times change a little bit," he said. "I am much more optimistic in terms of what the FDA may look like a year or two from now in terms of the industry's ability to get products through and onto the market."

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

FDA Communication On Missed Deadlines Can Help Avoid Drug Review Limbo

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