As I see it: Reorganizing the FDA means sweeping changes

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Whether or not Congress elects to reorganize the FDA, the Obama Administration's new leadership team at the agency vows sweeping changes are on the way, from drug safety to more transparency in everything the agency does.

In June, newly installed commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein held their first news conference to roll out Sharfstein's pet project, an executive-level task force on transparency.
While very broadly focused and a response to Obama's first-day directive to all agencies to be more transparent, the FDA task force's primary initial spur was the cascading public criticisms the agency has been getting over its slowness to release early drug safety concerns.

Despite the change in administrations, this is likely to remain a contentious subject. Industry does not want its products prematurely maligned, and the FDA does not want to be caught protecting an avoidable hazard.
Congressional overseers, suspecting that Bush-era holdovers with pro-industry agendas have embedded themselves in Obama's FDA, can be expected to hold the agency's feet to the fire on this one.

Even the task force itself quickly met criticism for its composition — numerically dominated by officials who helped build the non-transparent structures and procedures they are now charged with dismantling.

No one doubts the dedication of Sharfstein, who is chairing the task force, to transparency. Nor has Hamburg been lukewarm in her support for the effort, which has the full weight of Obama's Day 1 directive behind it.
But this is an extraordinarily impervious agency with a decades-long culture of secretiveness and stubbornness. Some of the secrecy is necessary and legally mandated — protecting trade secrets and patient privacy, for instance — but acres of it are ingrained, cover-your-ass encrustations that serve to resist reform and preserve personal fiefdoms.

As one old FDA hand told me when Reagan took office with a government reform agenda: “Commissioners come and commissioners go — but we stay here.” And so do their habits.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)
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