Pulling Back The Curtain on the FDA

From the FDA’s Public Meeting on Transparency at the National Transportation Safety Board Conference Center, Washington, DC

Outside of the C.I.A., the Food and Drug Administration (FDA) has been one of the most enigmatic federal agencies, inscrutable to the industries it regulates, a mystery to the public, and feared by executives at small publicly traded companies whose stock can take wild swings in response to the slightest whisper from the Emerald City, that is, White Oak, Md.


Courtesy Flickr Creative Commons User dbking

But like Dorothy and her raggedy band of cohorts, FDA Commissioner Margaret Hamburg and her deputy Joshua Sharfstein are determined to pull back the curtain and expose the inner workings of Oz.

As a start, they’ve organized a “transparency” initiative (details are here). On Tuesday, Dr. Sharfstein led discussions with a panel of agency colleagues, industry, physicians, and consumers on hypothetical situations where the agency would be called on to say, communicate to the public about a foodborne disease outbreak, or let manufacturers know how and why it had made a decision about a new drug approval.

The agency plans to eventually make all its decision-making processes more accessible to everyone – and soon, said Dr. Sharfstein.  First, it will create an “FDA 101” area on its website, envisioned as an interactive area for consumers to learn all about the agency’s mission and inner workings.

The second phase will be finding a way to explain to the public how the agency makes its decisions; last, it will become more accountable to industry.

With almost-daily and ever-larger outbreaks of foodborne illnesses, growing pharmaceutical and device recalls, and sporadic epidemics like H1N1 influenza, the discussions are not just academic. Being able to communicate – and quickly communicate — fact-based public health information is crucial, especially when misinformation proliferates so quickly these days.

The Centers for Disease Control and Prevention has long cultivated its reputation as a credible source of information in times of crisis and has also developed strong relationships with the partners it needs to rely on – physicians and scientists – during those crises.

The FDA, which has just as big a stake, has operated in some kind of alternate universe.  But, a whirlwind election blew in the force of change.

Will Dorothy, that is, Dr. Hamburg, be able to bring the agency back to reality?

–Alicia Ault (on Twitter @aliciaault)

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