FDA’s transparency effort has new features, old content


Hot off the cyber-presses is this new Web site section from the U.S. Food and Drug Administration (FDA), designed to tell us viewers what the agency does and how it does it, in plain and simple language. The agency says this is its first step in its transparency initiative, and that it represents its response to comments from the public, which wants “basic information about the agency in a user-friendly, accessible format.”

Upon a very quick perusul, the new Web site section looks fine as far as it goes. Certainly it’s useful having a place on the site where we can find out that the FDA regulates drugs, food and medical devices, among other products (although does it really take a transparency initiative to provide this basic information?). It’s nice to have contact information for agency officials and short videos about what they do (although we haven’t watched any of them yet).

But it appears there is nothing here that the agency has not already provided to the public–albeit not wrapped up as nicely.

Here, for example, we find out how the approval process for prescription drugs works. But you wouldn’t know from reading this that the agency does not make available online the background research collected as part of the approval process for nine out of the 25 most prescribed drugs, as we reported here.

The agency says that the next phase of its transparency initiative will take place when its Transparency Task Force makes recommendations to the FDA commissioner about “how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agencys goal of protecting confidential information, as appropriate.” We’ll be watching closely as the agency moves forward and will report here about it.