The Naval Postgraduate School & The U.S. Department of Homeland Security

FDA Releases Strategic Priorities Plan

Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century The U.S. Food and Drug Administration has released its five year plan outlining strategic priorities that will guide the agency through 2015. The plan is “intended to communicate … key priorities, including cross-cutting strategic priorities, program-specific strategic goals, and long-term objectives. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA’s public health mission and to fulfill [its] role in supporting the larger mission and strategic goals of [the Department of Health and Human Services].” In supporting the aforementioned mission, the FDA’s long-term objectives include the need to “increase the nation’s preparedness to address threats as a result of bioterrorism, pandemic and emerging infectious diseases.” The plan states that “[d]espite considerable financial and human resource investments since 2001, the United States does not yet have the range of medical countermeasures (MCMs) it requires to rapidly and effectively respond to a deliberate chemical, biological (such as anthrax or smallpox), radiological or nuclear event or naturally-occurring infectious disease outbreaks. There are few FDA-approved MCMs (drugs, vaccines, diagnostic tests, personal protective equipment, and supplies) to respond to these types of public health emergencies. Moreover, there is limited capability to rapidly develop a new MCM in response to a new or emerging threat, and only limited capacity to ramp up production of existing MCMs once an event is detected."