New Drug Approval Rate – Not What it Used to Be

J0422663In news that doesn’t surprise most of us who have been watching FDA approvals, it would appear that someone has gone and counted up the approval rate and the rate of approvals for new drugs has, in fact, gone down. 

This news comes on the heels of the issuance of yet another approvable letter by the FDA, this time to Indevus Pharmaceuticals, Inc. for Valstar, a bladder cancer treatment that had been approved, but was subsequently withdrawn from the market due to impurities.   According to the Chairman and CEO of the company, "The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process related investigations. We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re- introduction."  No more specificity was offered in the company release

The Associated Press story on the FDA slowdown of the pipeline quotes FDA spokesman Christopher Kelly to say that "There have been no systematic changes in how we are approaching the approval standards for new applications." "Whether the current public debate and criticism of FDA on drug safety has played any role in our actions is very hard to quantify."

It may be true that it is hard to quantify, but my gut tells me that it is undeniable.  I also think that it makes sense given the pounding that the agency has taken from policy makers on the Hill as well as in the media and by critics.  That said, rather than say it is hard to quantify, I think that both patients and investors might benefit from the FDA attempting to quantify the issue and then explain what the new rules of the game are going to be.  As it is, expectations of both patients and investors are in alignment with a reality that may no longer exist. 

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