FDA's Transparency Initiative Opens Up New Information to Disclosure

Online Exclusive: Inside the FDA.

The impact of President Obama's Day One memo calling for "an unprecedented level of openness in government" reached the FDA in June 2009 when the agency announced the formation of a task force to increase transparency of its internal operations.

Proposal 10 calls for the FDA to disclose the submission of applications to market a drug. The task force's report justifies the proposal as helpful to, for example, patients suffering from a specific disease who often query the FDA for information on new drugs.

But that information generally has remained undisclosed in the past, with the companies that sponsor the applications carefully controlling any release of information. The implications of making it all public could be great, threatening to give competitors a look into companies' future marketing plans.

Associate Editor

Melissa Maleske

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