FDA’s “Roadside Bombs” and “Insurgents”

“Roadside bombs” and “insurgents” aren’t typically found in FDA’s regulatory lexicon. But that’s how FDA’s former drug center director Carl Peck described the situation the agency finds itself in right now.

Peck, speaking at the Food and Drug Law Institute’s annual meeting March 27, was referring specifically to a study making headlines today in the New England Journal of Medicine. The study, authored by well-known Harvard researcher Daniel Carpenter, looked at new molecular entity approvals between 1950 to 2005 and found that drugs approved close to the prescription drug user fee deadline ran a higher risk of being withdrawn and receiving a “black box” warning compared to those drug approved earlier in the cycle.

“The conclusion is that drugs approved just before PDUFA deadlines are less safe than those approved well before,” Peck pointed out after a solid criticism of “ambitious politicians” and “media competing for sales-enhancing headlines” (the IN VIVO blog is obviously not shackled by this particular criticism since the blog is free…remember that, people).

More specifically, drugs approved two months before the PDUFA deadline carry a 5.5 excess risk of being withdrawn and a 4.4 excess risk of getting a “black box” warnings. To read the NEJM abstract, click here.

FDA isn’t taking this one sitting down.

“FDA has tried to confirm the numbers that are in that article and we have been unable to,” Center for Drug Evaluation & Research deputy director Douglas Throckmorton commented at the FDLI meeting. “The numbers we have gotten are considerably different.”

The Wall Street Journal first reported that FDA was sending a protest letter to NEJM related to the study findings. To read the story, click here. Throckmorton says the discrepancy between FDA figures and Carpenter’s figures aren’t negligible. “We need to know what those numbers really are before we try to interpret them and we have a group within the FDA that’s working to try to understand where that difference is because it’s considerable.”

Throckmorton also pointed out what everyone in the biotech and pharmaceutical industries already know: almost every single new drug approval occurs at or just before the user fee deadline date. “The small fraction of products that aren’t—it’s an important fraction to look at—but whether that’s a balanced representation of what we’re doing” is debatable.

The CDER deputy highlighted that this is one particular research question that has a “right answer” and isn’t up for interpretation.

In other words, this isn’t likely to be a study to go the route of Avandia and other drug safety issues that never produced a general consensus. Judging from Throckmorton’s comments, the agency appears confident that it has the right numbers, not the academics. If that’s the case, chalk one up to FDA. Finally.