On-deadline drug data disputed

Yesterday, a study [1] that seemed to show on-deadline drug approvals led to more safety problems. Today, the fallout and reaction. The FDA says that, try as it might, it can't replicate the Harvard study's numbers. The agency is sending a detailed letter disputing the results to the New England Journal of Medicine, which published the research. And at an industry conference yesterday, a former CDER director and current deputy director took aim at the study.

Deputy director Douglas Throckmorton pointed out that the vast majority of new drugs are approved at or just before the user-fee deadline date. And, he said, the differences between the FDA's data and the study's data aren't small. "We have a group within the FDA that's working to try to understand where that difference is because it's considerable," he said.

Meanwhile, FDA officials reminded the Wall Street Journal that they recently relaxed their rules on meeting PDUFA deadlines. Managers were authorized to miss a deadline if necessary, they said.

- read the FDA pushback [2] at In Vivo
- see the WSJ's comprehensive article [3]

ALSO: In a speech yesterday, FDA Commissioner Andrew von Eschenbach said the FDA "may fail" to protect Americans' health. "Peril exists," he said, adding that the FDA needs to be bigger and better to do its work well. Democratic lawmakers, however, say von Eschenbach hasn't asked the Bush administration for enough additional funding, even after the prompting of Congress. More FDA funding debate is sure to come. Report [4]

Related Articles:
Study: Last-minute drugs less safe. Report [1]
PDUFA debate highlights drug safety issues. Report [5]
Developers: Politics behind slow approval process. Report [6]
The FDA: Caught between a rock and a hard place. Report [7]
FDA quick to reject drugs as it gets more cautious. Report [8]