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FDA Transparency Initiative: Draft Proposals for Public Comment

May 26, 2010

Find the draft proposals here.

From Dr. Sharfstein at the FDA:

Last summer, FDA Commissioner Dr. Margaret Hamburg launched the Transparency Initiative. It has been my pleasure to chair an internal task force charged with developing recommendations for Commissioner Hamburg’s review.
Today, as part of the second phase of this effort, FDA is releasing a draft report on the public disclosure policies of FDA. Our goal is to facilitate transparency that promotes public health and innovation.
The report proposes for public comment 21 specific draft proposals. These draft proposals reflect close review of more than 1,500 public comments and extensive consideration and discussion within FDA.
These steps would:
  • Better explain FDA decisions. One proposal for comment is for the agency to explain the rationale when the agency declines to approve medical products. This explanation can support the development and approval of improved products.
  • Provide more data to doctors and patients. A proposal would permit FDA to release summary data on safety and effectiveness from medical product applications when doing so would clear misconceptions or promote public health.
  • Illuminate enforcement efforts. A proposal would have FDA post the classification of every inspection by agency staff. This information could be very useful to consumers and purchasers of medical products and food.

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