FDA Issues Info Release Guidance

The Food and Drug Admnistration has released guidance for manufacturers when they submit data to the agency in advance of advisory committee meetings. Nothing yet, though, on a new policy aimed at eliminating conflicts of interest on those committees, which should be one of the many issues discussed later today by Commissioner Andrew von Eschenbach when he appears before the House Appropriations subcommittee.

In the latest guidance, the agency promised to release their own analysis and industry-submitted data to the public at least two days in advance of public meetings. This would be a slight improvement over current practice. It usually releases the briefing documents about a day ahead of time.

The document, which was vetted by former American Enterprise Institute fellow Randall Lutter, who now runs the FDA's Office of Policy, gave industry plenty of leeway for redacting information it considers confidential business information. It also gave industry the right to review the FDA's presentation and make comments. If a company doesn't like the final document and goes to court to stop its public release, the agency might postpone the meeting, the document warned.