FDA has released eight new draft proposals in a report titled "Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency's Compliance and Enforcement Data."

These draft proposals are focused on making FDA's compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA's operations and decision-making.

In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data Web sites (www.epa-echo.gov1 and http://ogesdw.dol.gov2, respectively). At these meetings, EPA and DOL shared their insights to help FDA learn from, and build upon, their experiences. Like FDA, EPA and DOL recognize that transparency can drive good behavior and promote regulatory compliance.

After consulting with EPA and DOL, FDA developed the eight draft proposals that it issued last week. The public may provide comments on the draft until Dec 2, 2011. FDA Commissioner Margaret Hamburg, MD, launched FDA's Transparency Initiative in June 2009. The initiative is overseen by a Task Force that includes key leaders of FDA. The new report issued advances that initiative and is part of FDA's response to President Obama's Presidential Memorandum on Regulatory Compliance, which directed federal agencies to make compliance information more publicly available, easily accessible, downloadable and searchable online.