FDA and drug safety (or lack thereof_

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http://content.nejm.org/cgi/content/full/357/10/960

"Several IOM recommendations speak to the importance of including safety
experts as integral players in the drug-review process. Yet instead of
undertaking a fundamental restructuring to integrate the relevant
offices, the FDA merely initiated two pilot projects that involve OSE
personnel in drug reviews to determine the "logistics and value" of
doing so. But something akin to a pilot had already been done. More than
10 years ago, Greg Burkhart moved from the Epidemiology Branch (now the
OSE) to the Division of Neuropharmacological Drug Products (now the
Divisions of Neurology Products and Psychiatry Products in one of the
Offices of Drug Evaluation). His successor in the latter post, Judith
Racoosin, who had trained as a postdoctoral fellow in the OSE, spoke to
the IOM committee in January 2006 about her work as a safety team
leader.1 It is partially on the basis of her experience that the IOM
report argues that a critical step in promoting a culture of safety is
to change the role of the safety expert from occasional consultant to
vital participant in the day-to-day work of regulatory decision making."

Susan