FDA keeps heat on data--but lets itself off the PDUFA hook

In 2008 the FDA approved 24 applications for new chemical entities. OK, that wasn't great, but it was an improvement. In 2007 the record was a paltry 18 [1]. Up is good. But 24 is hardly a turnaround number.

This year look for the FDA to continue to ratchet up the heat on data, just as it did in late 2008 for new diabetes therapies [2]. Another sign of the difficulties ahead: One of the agency's expert committees recently rejected a move to use retrospective data analysis to make its case for personalizing cancer drugs to specific subpopulations. Deep institutional skepticism, bred by safety fiascos that will linger long in the agency's memory, will dictate caution even as the FDA insists it is backing a streamlined approach to clinical development.

The agency itself, though, is looking anything but streamlined these days. Time after time, the FDA missed its PDUFA deadline in 2008. The deadlines are the agency's half of a long-standing bargain it made in exchange for the industry's financial support. With the government looking to rack up enormous deficits in an attempt to fuel an economic revival, it's unlikely that FDA funding will be sufficient to meet its deadline commitments in 2009. That means more lost time and value for developers who need clarification from the FDA sooner than they're likely to get it. Once you lay the groundwork for failure, you guarantee that it will happen over and over again.

Related Articles:
FDA approvals up in '08, missed deadlines abound [3]
2008 NME approvals will surpass 2007 [4]
FDA: Don't blame us for sparse approvals [5]
FDA official says approval deadlines will be broken [6]