Transparency Initiative Report Draft Proposals
October 4, 2011
Dear International Colleague:
In January 2009, President Obama issued a memorandum instructing U.S. executive departments and agencies to take specific actions to implement the principles of transparent, collaborative, and participatory government. In response to the President’s directive, U.S. FDA Commissioner Dr. Margaret Hamburg convened a Task Force and launched FDA's Transparency Initiative in June 2009, culminating in a report proposing 21 initiatives to increase public disclosures about our agency's activities. A copy of the report can be found at:
Following his initial directive, in January, 2011, President Obama issued a subsequent mandate to all U.S. federal agencies directing them to specifically make information about their compliance and enforcement activities more transparent and accessible to the public. FDA responded to this challenge and in May, 2011, informed the public, including the international community, about the first in the series of steps we were implementing to specifically make our inspection and compliance activities more transparent in response to President Obama’s directive.
FDA believes that increasing the transparency of its compliance and enforcement activities allows the public to better understand the Agency’s decisions, and promotes accountability of the Agency and the regulated industry. In the May announcement, FDA reported that we had (1) enhanced the posting of press releases on our website regarding the filing and resolution of enforcement actions, (2) posted a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections1; and (2) provided a searchable database that included the names and addresses of inspected facilities, the date(s) of inspection, the type of FDA-regulated products covered during the inspection, and the final inspection classification2.
I am pleased to report that on Monday of this week FDA released eight new draft proposals to promote greater access to the Agency’s compliance and enforcement data. These eight proposals are the latest in FDA’s series of efforts to continue to ensure that the Agency’s enforcement and compliance-related activities are accessible, down-loadable, and searchable online. In developing these draft proposals, FDA consulted with the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Labor (DOL), both of which have well-developed and well-regarded enforcement information databases, so that the Agency could learn from, and build upon, their experiences and best practices. Like FDA, EPA and DOL recognize that transparency can drive good behavior and promote regulatory compliance. More details about the eight draft proposals are included in the report entitled, “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.” The report and eight draft proposals can be found at:
FDA is soliciting public comment on these eight draft proposals for 60 days. We welcome the feedback from our international colleagues regarding these eight draft proposals, and I strongly encourage you to submit comments by December 2, 2011 either electronically at http://www.regulations.gov, or in writing to:
The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
The Task Force will recommend specific draft proposals to the Commissioner for consideration based on the public comments that are received, the feasibility of the draft proposal, the relative priority assigned to each proposal, and resource constraints. The Commissioner will then determine whether to adopt any of these draft proposals by January 31, 2012.
In the coming months, additional transparency actions will be implemented and we will continue to move forward with other proposals. More information about FDA’s Transparency Initiative can be found at:
If you have any questions about this initiative, please contact me at + 1-301-796-8400 or at MaryLou.Valdez@fda.hhs.gov
Mary Lou Valdez, MSM
Associate Commissioner for International Programs
1Inspection Observations, FDA, http://www.fda.gov/ICECI/EnforcementActions/ucm250720.htm
2Inspections Database, FDA, http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm