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FDA Launches Transparency Task Force


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-06-04-2009
Volume 0
Issue 0

The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed.

FDA, on Tuesday, announced the formation of a transparency task force, charged with determining how to make the agency and its actions more apparent to the general public. The new program is being created in direct response to President Obama’s comments that the new administration will be more open to public participation in government.

A first impression: Judging by the clarity and detail of the announcement, the task force has its work cut out for it.

“Over the years, there have been complaints made against FDA’s lack of transparency,” said FDA Commissioner Margaret Hamburg in a press call. “The agency has been referred to as a black box that makes important decisions without explaining them. While the agency can’t disclose all types of information, I believe that the agency can do a better job of providing useful information to the public in a timely manner.”

Hamburg says she wants all stakeholders-physicians, pharma, and the public-to provide suggestions as to how the agency can best inform the public. The task force is holding two public meetings, establishing a public list of important issues to consider, and using the Internet to allow the public to provide comments and feedback to the agency.

FDA Deputy Commissioner Joshua Sharfstein will be chairing the internal task force on transparency.

Transparency About Transparency
Given the tenor of the past few years’ attacks on the agency, there’s a good chance that the proceedings will be dominated by the usual suspects-David Graham, Steve Nissen, Marcia Angell, and the like-wanting exactly what they have wanted for ages: everything. It’s easy to imagine that hearings will lead to a well-documented demand for full access to clinical trials data, personal information about advisory board members, and full documentation about every internal disagreement at an agency at which scientific debate is supposed to lead to decision-making, not an endless continuation of debate.

Here’s a prediction: The transparency task force’s first crisis will be explaining why they can’t provide more information on how they decided not to give critics everything in their shopping baskets.

Sharfstein, meanwhile, says FDA is approaching the initiative less from the angle of fixing past transparency problems, and more to take a fresh look at what information the public wants to see made public, including the possibility of releasing clinical trial data.

And how will the FDA find resources to run the task force?

The commissioner was vague in her response, stating only that she would work with the task force on implementation after the requests are read. She also said that there might be fewer requests and citizen petitions for information, leading to a decrease in resources.

A more complicated question is how this new, more transparent FDA be affected by laws that have been put in place to keep proprietary secrets secret is still unknown. Hamburg said that FDA would be reviewing procedures surrounding accessibility of information.

“I think we will see a range of areas of needed activity that will require different solutions to address them,” Hamburg said. “Certain types of information such as reports and documents can just be put up on the web site in a timely way, other types of information dealing with clinical trials data will require a very different framework to make it available.”

“Currently there are obligations to protect confidential information and I don’t think FDA or the Obama administration is suggesting that they be disregarded,” said Jill Kopeikin, partner at Dechert LLP told Pharm Exec on Wednesday. “But the parameters could be implicated and that is the question that people will be watching closely.”

The first public task force meeting will be held Wednesday, June 24.

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