Letter from Task Force Chair
President Obama’s Administration and the U.S. Department of Health and Human Services have made a priority of promoting openness in government. At the U.S. Food and Drug Administration (FDA), we recognize that the successful implementation of this principle will enhance our ability to promote and protect public health. The public, Congress, media, and industry should all understand how FDA operates and why the agency makes key decisions.
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.
- Support innovation for rare diseases. A proposal would allow FDA to explain that an abandoned application for an orphan drug could represent a significant therapeutic advance. This could incentivize another company to continue with the application.
We invite public comment on these draft proposals, including input on whether we have struck the right balance between disclosure and confidentiality in support of public health. Because FDA cannot implement all of the proposals at once, we are asking for input on how to prioritize. Please visit www.fda.gov/transparency to provide your thoughts.
The Task Force will consider the public comments, the operational feasibility, priority, and resource requirements required to recommend specific proposals to Commissioner Hamburg for consideration.
We look forward to your continued participation in the Transparency Initiative.
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
Chair of the Transparency Task Force