FDA Unveils Next Steps in Transparency Initiative, Public Comment Requested
By Rachel Walden — May 20, 2010
The U.S. Food and Drug Administration last year formed a task force to increase the agency’s transparency to the public, with a goal to “develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.” This effort stems from the Obama administration’s goal of increasing the transparency of government agencies in general.
In a newly published perspective piece for the New England Journal of Medicine, representatives of the FDA’s transparency initiative describe the task force’s work to date, including release of a website, FDA Basics, “to answer fundamental questions about how the agency does its work.”
Today, the agency has released a report [PDF] from the task force outlining draft proposals “for expanding the disclosure of information by the agency while maintaining confidentiality for trade secrets and individually identifiable patient information.”
The proposal document is fairly technical and seems to assume a fair bit of background knowledge of FDA procedures and policies, but it includes proposals such as disclosing information about commonly observed violations associated with FDA-regulated products, the status of terminated and withdrawn new drug and device applications, and summary safety and efficacy information related to investigational new drug applications (data that may not have been published in the medical literature) when the agency determines the information is necessary to protect the public health
The agency will be accepting public comment on the proposal, including which draft proposals should be given priority, until July 20, 2010 via regulations.gov (direct link for comments not yet available). The FDA has also set up a transparency-related blog for updates on these efforts.
Added: you can now go here at Regulations.gov to submit comment, due by July 20, 2010.
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