Apr 9 2014
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FDA’s Role in Disaster Preparedness: Q&A with Brooke Courtney

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The U.S. Food and Drug Administration (FDA) was a partner agency for last week’s Preparedness Summit in Atlanta. NewPublicHealth spoke with Brooke Courtney, Senior Regulatory Counsel in the FDA Office of Counterterrorism and Emerging Threats, about how the agency plans for disasters it hopes never occur. Previously, Courtney was the Preparedness Director at the Baltimore City Health Department and in that role oversaw all of the public health preparedness and response activities for Baltimore City.

NewPublicHealth: What did you speak about at the Summit last week?

Brooke Courtney: FDA views the summit as an unparalleled opportunity each year to engage with stakeholders at the state, local and federal levels—to share with them updates from the federal side and also for us to get feedback from them about challenges and successes. We engage with stakeholders on a regular basis, but this is really the meeting where the largest number of people involved in preparedness come together, and it’s a great opportunity to see people face-to-face.

We feel really fortunate to have been able to take part in the summit for the past few years. For this year’s summit FDA served on the Planning Committee and also participated in the medical countermeasure policy town hall with federal colleagues from the Office of the Assistant Secretary for Preparedness and Response, the U.S. Department of Homeland Security and the national security staff, all of whom we work with closely.

Another thing that we like to do at the summit each year is to give a more in-depth update through a session with the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Department for Health and Human Services (HHS) legal counsel on the authorities that we have that we use related to the emergency use of medical countermeasures during emergencies. This year’s session was especially exciting for us because it was an opportunity for us to discuss with stakeholders some new authorities that were established in 2013 to enhance preparedness and response flexibility.

For example, we can now clearly issue emergency use authorizations in advance of emergencies, which is really a critical medical countermeasure tool for preparedness purposes. Through these flexibilities, for example, we’ve issued three emergency use authorizations in the past year for three different in-vitro diagnostic tests to address the emerging threats of H7 and 9 influenza and MERS-CoV.

NPH: What are the key responsibilities the FDA has in helping to prepare the United States for possible disasters?

Courtney: As an agency of the U.S. Department of Health and Human Services, the FDA, at its core, is a public health agency. FDA’s mission is to protect and promote public health in a number of critical ways. We’re responsible for regulating more than $1 trillion in consumer goods annually, ranging from medical products such as drugs and vaccines to tobacco and food products.

In terms of public health preparedness, we play a critical role in protecting the nation from chemical, biological, radiological and nuclear threats, and also emerging infectious disease threats such as pandemic influenza. What we’re responsible for is ensuring that medical countermeasures—which are the products such as drugs, vaccines and diagnostic tests to counter those threats—are safe, effective and secure. We do that through the Office of Counterterrorism and Emerging Threats, where we focus on a range of activities from the early stages of product development all the way through product use during a public health emergency such as an influenza pandemic or an anthrax attack. FDA’s product centers, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiologic Health also have expert teams that focus on medical countermeasure development and use issues.

So collectively, FDA does things such as review medical countermeasure applications and approve those that meet applicable standards for safety and efficacy, and we also use special legal and regulatory authorities to permit certain countermeasure preparedness and response activities even when products might still be investigational or not yet approved, if those might be the best products available for an emergency. Then when needed, if countermeasures are ultimately used during a response, we can monitor them for adverse events.

We also work directly with state and local public health and healthcare agencies to help them address an array of preparedness and response challenges, such as stockpiling countermeasure products.

And at FDA we also have an Office of Crisis Management that coordinates the agency’s overall responses to a wide range of emergencies such as foodborne illness outbreaks. We also respond to emerging challenges such as drug shortages which have had an impact on the health care system. And really underlying all of these efforts to protect the public health is a strong legal and regulatory framework that allows us to do our work in ensuring the availability of safe products. For example, in the area of preparedness, the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) greatly enhances countermeasure preparedness from the local community all the way to the federal levels. In other areas such as food safety and drug quality the law plays just as important a role; the FDA Food Safety Modernization Act and the Drug Quality and Security Act are just two examples of laws that are critical to what we do at FDA.

NPH: What do local and state departments need to know more about FDA’s preparedness role?

Courtney: We really want health agencies to see us as a partner in preparedness, so we’re never trying to stand in the way of response. Really on the contrary, our goal is to use our authorities and our polices to maximize response flexibility, but while also striking this very difficult balance of protecting the public health and patient safety.

So really a lot of what we work on in the countermeasure world is so complex, and one of my roles at the FDA is to engage with state and local partners, and so I always encourage health agencies and other partners to reach out to us directly with any questions or concerns. We even like to hear about successes, although we often mostly hear about concerns.

NPH: What are some of the most recent developments in FDA’s preparedness work?

Courtney: In 2010, FDA launched its medical countermeasures initiative to not only focus increased resources on identifying and resolving challenges to countermeasure development and access, but also to enhance countermeasure engagement coordination and collaboration both within FDA and with our external partners.

Since this initiative was established we’ve had this increased focus on collaboration and it has resulted in a number of very important countermeasure approvals, including an inhalational anthrax therapeutic and a botulism antitoxin. Seasonal flu preparedness in this area is also critical for helping to increase and to sustain pandemic influenza production capacity for vaccines. And so, for example, in that realm we’ve recently approved several new seasonal flu vaccines, including the first seasonal flu vaccine that’s licensed in the United States using modern cell culture techniques to help ensure faster manufacturing startup.

Another area we’re focused on is looking at surveillance of how medical countermeasures work, and how they perform when they’re actually used. So we’re looking at different ways we might be able to collect clinical data on that during an emergency to help inform an ongoing response or future responses. For example, we’re looking at how we might be able to obtain data from electronic health records  in real-time, and then if we’re able to do that we can translate that into decision making about use of a particular countermeasure during the actual emergency.

Tags: Disasters, Emergency preparedness and response, Food and Drug Administration, Preparedness, Public health agencies, Q&A