The FDA wants to be more open and transparent to the public--but so far it's pretty secretive on just how open it's prepared to be. Yesterday, FDA Commissioner Margaret Hamburg said she'd created a task force to recommend ways to open its files on drug evaluation and enforcement. Given the fact that it's entrusted with stacks and stacks of proprietary information from drug and device makers, the agency can't just dump data onto its website willy-nilly.
But given that fact--that so much of the information it possesses is considered proprietary--how can the FDA be more open? Well, Hamburg thinks that the agency has been leaning too far toward the secrecy side. Some of the info it routinely keeps under wraps could and should be released, she said. "The agency has been referred to as a 'black box,' " she said.
Should the FDA air data from unpublished clinical trials? Should it be quicker on the draw when it comes to airing safety concerns? Hamburg says her task force will consider these and other questions, asking for input from drugmakers, researchers, consumers and so on. In some cases FDA may be able to choose to release info on its own; in others, the agency may need Congress to intervene to make disclosure legal. Want to put your two cents into the debate? The first public meeting will be June 24.
- see the news from FDA
- read the Reuters story
- check out the post at the WSJ Health Blog