FDA unveils “basics” site as part of transparency plan
Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.
FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration. In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.
But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance. Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.
Phase three will establish how the agency interacts transparently with regulated industries.
Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.
Check out FDA Basics here.
–Kate Petersen, PostScript blogger