FDA is finding the possible release of its voluminous documents one of the more challenging aspects of the effort to make its operations and decisions more open to the public, and the challenges are both in policies and resources, FDA's Janet Woodcock says.

There may be billions of documents that FDA potentially could release or make available for public viewing, the Center for Drug Evaluation and Research director observed, and while perhaps the agency should make them available, no one has solved the great logistical problem that would result.

During her April 22 presentation to the Food and Drug Law Institute's annual meeting, Woodcock was asked when FDA would translate its commitment to the idea of transparency into a greater number of concrete actions.

"The answer, honestly, is I don't know," she said. "These things all take time and resources, dedication ... So I can't actually tell you."

FDA's transparency initiative has three components: providing information to the public via a website about what the agency does; deciding what types of information can be disclosed (for example about new safety issues or product applications), and being more transparent to industry about its processes (Also see "FDA's Transparency Initiative Enters The "What Is The Right Thing To Do" Phase: An Interview With Principal Deputy Commissioner Sharfstein" - Pink Sheet, 30 November, 2009.).

The agency recently unveiled a website, "FDA-Track," reporting metrics such as how many product adverse event reports the agency has received each month, how many first-time generic products it has approved, and how many Risk Evaluation and Mitigation Strategy plans it cleared (Also see "FDA Launches New System To Track Performances of Its Offices" - Pink Sheet, 7 April, 2010.). And the agency just issued a draft guidance requiring more disclosure of advisory committee members' possible financial conflicts of interest (Also see "FDA Working To Fill Advisory Panel Vacancies While Tightening Conflict-Of-Interest Rules" - Pink Sheet, 21 April, 2010.).

But some stakeholders have called on the agency to take transparency into newer areas, such as releasing product application "complete response" letters, now considered proprietary to the sponsor, or providing more information on how it develops REMS (Also see "Jenkins Suggests "Complete Response" Letter Transparency Could Prompt Better Drug Applications, Faster Reviews" - Pink Sheet, 7 December, 2009.).

Dealing with documents is not as simple as posting them on the FDA website, it appears. Woodcock said nearly all of them would require some redacting of proprietary or other sensitive information for legal protection. She said when the number of pages reaches into the billions, it is a massive workload.

"Now the only practical thing would be people would send in the information and send in an already-redacted copy," Woodcock said. "And then I think we would be subject ... to all the other people that want the information out there telling us 'Well, it was excessively redacted, you have to go back and look at it and make sure that the pre-redacted copy was redacted correctly.'"

Even FDA-generated documents and exhibits that are posted on its website are not easily uploaded and many simply are not released because they are too difficult to upload.

Woodcock noted for example, that FDA has to comply with laws requiring electronic federal documents and other material to be made available to people with disabilities. That includes making electronic presentation slides understandable for consumers, which would take a lot of extra time.

"So what do we do? We don't post it," Woodcock said. "And each group of things that we would like to post or make public, there is a constituency that would like not to post and (would) like them to remain confidential."

-Derrick Gingery (d.gingery@elsevier.com)

FDA Transparency Initiative Sees No Clear Path To Releasing Documents, Woodcock Indicates

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