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Pharma Blog Watch

September 25, 2006

IOM Report (Eye on FDA)
In his blog, Mark Senak discusses the Institute of Medicine (IOM) report released last week, "The Future of Drug Safety: Promoting and Protecting the Health of the Public." "Neither the problems cited, nor the recommendations are new," he writes, adding that he has discussed many of them in his blog.

"What is new is that IOM reports do carry gravitas that generally provokes reaction and momentum to create change," he writes. "As stated many times, the FDA needs a PLAN."

Proposed DTC Moratorium (Pharma Marketing Blog)
In his entry, John Mack also addresses the report, specifically what he says is a recommendation calling for a two-year moratorium on direct-to-consumer (DTC) advertising of new drugs.

"If pharmaceutical companies want to be consumer-friendly and enjoy the right to market their products directly to consumers, then they must not settle for a 3% drug recall rate, [in my opinion]. They may not have to go as far as Six Sigma, but how about at least Six Thousand Sigma (ie, a 0.34% drug recall rate)?" he writes.