In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.Brooke Courtney, JD, MPH, is Senior Regulatory Counsel, Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner; Katherine C. Bond, ScD, is Director, Office

SummaryDespite substantial investments since the events of 2001, much work remains to prepare the nation for a chemical, biological, radiological or nuclear (CBRN) attack or to respond to an emerging infectious disease threat. Following a 2010 review of the US Public Health Emergency Medical Countermeasures Enterprise, FDA launched its Medical Countermeasures initiative (MCMi) to facilitate the development and availability of medical products to counter CBRN and emerging disease threats. As a regulatory agency, FDA has a unique and critical part to play in this national undertaking. Using a three‐pillar approach, FDA is addressing key challenges associated with the regulatory review process for medical countermeasures; gaps in regulatory science for MCM development and evaluation; and issues related to the legal, regulatory and policy framework for an effective public health response. Filling the gaps in the MCM Enterprise is a huge national undertaking, requiring the collaboration of all stakeholders, including federal partners, current and prospective developers of medical countermeasures, relevant research organizations, and state and local responders. Especially critical to success are an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures – and the systems to deliver them – and the requisite support of all stakeholders, including national leadership.

Electronic data collected from routine health care can be used for public health surveillance. To examine the Sentinel System, a distributed data network of health plans, as a source for influenza surveillance, we compared trends in outpatient prescription dispensings of influenza antivirals in Sentinel to trends in CDC's ILINet and NREVSS systems over five seasons. There were 2 102 885 dispensed prescriptions of oseltamivir capsules, 494 188 of oseltamivir powder, and 7955 of zanamivir. Across all seasons, the magnitude and timing of peaks in drug utilization were highly comparable to those in ILINet and NREVSS. Oseltamivir capsules and powder were well correlated with ILINet and NREVSS. This lays the foundation for further exploration of Sentinel's utility for influenza surveillance.

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Plans for mass distribution of medical countermeasures raise challenging problems, including legal and regulatory issues. Many in the distribution chain have expressed concerns over the potential for liability when countermeasures are distributed in accordance with large‐scale response plans. This is of particular concern if the medical countermeasure involved has not been approved, cleared, or licensed by the US Food and Drug Administration (FDA). This article discusses legal and regulatory options for countermeasure distribution that address liability concerns and access to unapproved countermeasures during an emergency.