Consider the following from BioCentury Extra:
FDA refutes PDUFA safety study
FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.
The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.
Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.
And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.
Well, as they say in Harvard Yard, "veritas."
We look forward to the FDAâ€™s review â€¦ and hopefully to an apology from the authors and a retraction from NEJM.