Monday, January 11, 2010

ESA Safety and the New, Transparent FDA

If you are interested in knowing what FDA thinks about important regulatory issues, including specific product reviews, it is time to renew your subscription to the New England Journal of Medicine.
A team of FDA officials, including Office of Drug Evaluation I Deputy Director Ellis Unger and Center for Drug Evaluation & Research Deputy Director for Clinical Science Robert Temple, used NEJM as a vehicle to announce a formal reassessment of the safety profile of erythropoeitin stimulating agents in chronic kidney disease, including an advisory committee review to consider (most likely) whether use should be limited to the minimum amount necessary to avoid the need for a blood transfusion.

The advisory committee isn't surprising; as we reported in The RPM Report last month, FDA was looking carefully at new clinical data suggesting that use of ESAs (Amgen's Aranesp, J&J's Procrit) may increase the risk of strokes in chronic kidney disease patients. And, given all the issues around safety of ESAs in oncology, an advisory committee was probably inevitable.

What is surprising is the forum to announce the plan.

But not too surprising. Unger previously used NEJM to publish a summary of the basis for approving Lilly/Daiichi Sankyo's Effient, after a long and controversial review. Former Merck drug safety head Peter Honig cited Unger's Effient editorial during an Institute of Medicine meeting on drug safety in September as a good way for the agency to explain its thinking about safety issues.

And Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein announced their agenda at FDA in an editorial published by NEJM on the day Hamburg took office.

We expect a lot more pharma execs will be scanning those headlines in weeks to come.

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