FDA’s traditional internal secrecy cracked ever-so-slightly open in September, when it announced its long-awaited decision on the uncertain risks of GlaxoSmithKline’s plummeting blockbuster, Avandia, for diabetes.
Instead of muzzling or exiling its internal dissenters, as it has in the past, the agency posted their reasons for taking it off the market as Europe had done, along with its own explaining the new labeling and distribution restrictions.
Two weeks later, it seeped out from principal deputy commissioner Joshua Sharfstein that the legal availability of these stringent limitations, known legally as Risk Evaluation and Management Strategies, was the only reason FDA didn’t follow the European example. FDA has been wrestling with how open it should be about its drug-safety moving targets for at least six years, and Avandia’s case is the first evidence of a significant opening.
One that is particularly tough is FDA inspections. Traditionally, this zipper-mouthed agency adopts an FBI-type attitude that it “can neither confirm nor deny the existence of an investigation,” but when pressed in high-profile cases like contaminated peanut butter or imported heparin, it can become quite a blabber mouth. Some lightening-up in more humdrum cases like routine inspections would help FDA redeem itself in the eyes of the public while convincing recalcitrant companies that it means business.
As the Avandia case demonstrated, transparency was a long time coming, and it took a lot of concerted pressure from many sources.
For now, FDA drug director Janet Woodcock has the last word regarding drug risk management: “We will aim for the maximum transparency possible.”
James G. Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the November 01, 2010 Issue of MM+M - Medical Marketing and Media
