FDA Issues Draft Strategic Priorities for 2011-2015
The Food and Drug Administration has issued a draft document entitled "Strategic Priorities 2011--2015: Responding to the Public Health Challenges of the 21st Century," which outlines the goals and priority areas that will guide FDA through the next five years.
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According to the draft plan, the FDA Commissioner has selected the following areas to serve as strategic priorities over the next five years, among other things.
Strengthening Global Supply Chain Through Prevention, Coordination, Etc.
Among FDA's priorities in the next five years is addressing the growing challenges of globalization, which have far outstripped U.S. resources for inspection and quality monitoring. Addressing these challenges will require focus on prevention, on stopping threats before they ever become reality.
FDA states that it must require more—and better—information about product supply chains and monitor this information throughout the product life cycle, and regulatory standards must foster corporate responsibility to identify, protect, and control risks. Such an effort will entail more and better coordination among foreign, federal, and state counterparts as well as novel and updated enforcement tools.
FDA must create a greater global safety net that consists of a global alliance of regulators, new authorities to allow for the creation of proactive tools for food safety, adequate funding to allow for more inspections, and updated systems (including IT support) to assist with the increased workload.
Strengthening Compliance and Enforcement Through New Programs, Data Sharing, Etc.
FDA is implementing a number of new programs designed to sharpen the effectiveness and timeliness of its regulatory, compliance, and enforcement systems. It is establishing deadlines for industry to respond to significant inspection findings, which will enable FDA to take enforcement action more rapidly if a manufacturer has not corrected violations documented after an inspection.
FDA will be implementing processes to prioritize followup inspections after it has issued a Warning Letter, classified a major recall, or taken other significant enforcement actions.
FDA will also work more closely with regulatory and enforcement partners to share laboratory and enforcement data and encourage them to take the immediate action in response to violations. FDA will remain involved in enforcement and compliance actions by notifying the public about the violative products and helping ensure longer term corrections are instituted.
(See FDA's draft plan for complete list of priorities, including advancing regulatory science and innovation and addressing unmet public health needs of women and children, among other things.
See ITT's Online Archives or 09/01/10 news, 10090141, for BP summary of FDA's launch of a "FDA-TRACK" in order to monitor program developments, provide accountability and transparency, and support the Open Government Initiative.
See ITT's Online Archives or 04/22/10 news, 10042249, for BP summary of FDA's plan to increase its authority over imports, etc.)
(Draft plan dated 09/29/10)