FDA stumbles toward transparency

Federal agencies have their marching orders from President Barack Obama — to become more transparent and open — but they have received little guidance on how to accomplish those goals.

The Food and Drug Administration has formed an internal task force to develop recommendations for making information about FDA activities and decisions readily available to the public, said Mary Long, an FDA spokeswoman.

The task force, which is chaired by Principal Deputy Commissioner Dr. Joshua Sharfstein, will kick off its effort with a public meeting on June 24.

“It will be one of our ways to reach out to the public about ways that we can make more FDA information available and in what format people would find most useful,” Long said.

While White House officials embrace Web 2.0 tools as a way to garner public input, FDA is starting with more low-tech methods. The agency will solicit comments at the June meeting and has planned another public meeting for the fall. FDA also set up a docket where the public can submit comments, similarly to how comments are accepted during the rule-making process.

Based on comments received at the first meeting, the task force might decide to employ Web-based tools to gather more input, Long said.

No specific area at FDA is being targeted to become more transparent, she added. That will be decided after public comments are gathered.

“You can imagine that it might include some compliance information or approval documents, but we really won’t know exactly what types of information, or what form it will take, until we get that feedback,” she said.

An important part of becoming transparent is making sure workers at every level of the agency see the value of doing so, said Ed Allera, an attorney at Buchanan Ingersoll and Rooney. His practice focuses on the development of pharmaceuticals and technology.

“You’ve got to really get to the people in the trenches who have to deal with releasing information or not on a daily basis, and encourage them and show them how this can make their lives easier,” Allera said.

FDA and other agencies should focus on making information about decision-making processes more open, said Gunnar Hellekson, a lead architect at Red Hat.

“So instead of just being able to find a regulation online, I can see all the documents, meetings [and] ex parte notices that led to that regulation being drafted,” Hellekson said.

“Obviously, this is a hard sell for most agencies,” he added. “They’re going to be very uncomfortable with this kind of disclosure, even if it has much greater value to the taxpayer.”