FDA Protecting the Nation Through Medical Countermeasures
By: Anna Abram, Deputy Commissioner for Policy, Legislation and International Affairs, and RADM Denise Hinton, Chief Scientist
The work to protect and promote public health at the U.S. Food and Drug Administration (FDA) takes many forms—from ensuring the safety and efficacy of medical products, to advancing a safe and nutritious food supply. These public health efforts improve the quality of life for Americans and help to keep our Nation safe. Our vital consumer public health mission also includes our work to protect the Nation from man-made health threats, such as a chemical, biological, radiological, or nuclear (CBRN) weapon, or from naturally-occurring ones, like pandemic influenza or Ebola. The ongoing Ebola outbreak in the Democratic Republic of the Congo underscores the need to remain vigilant in the face of these public health threats. It also spotlights the critical role played by safe and effective medical countermeasures, which include drugs, vaccines, and diagnostic tests, in countering such threats.
The FDA’s Medical Countermeasures Initiative (MCMi) furthers the development of medical countermeasures by establishing clear regulatory pathways and effective regulatory policies and mechanisms to facilitate timely access to available medical countermeasures. The initiative also advances medical countermeasure regulatory science to create the tools that support timely regulatory decision-making. As today’s new report on the FDA’s medical countermeasure-related activities and achievements in fiscal year (FY) 2018 underscores, these efforts are leading to results. Last year, the FDA approved 28 medical countermeasures, including the first drug with an indication to treat smallpox, an auto-injector for chemical nerve agent preparedness, and the first test to screen for Zika virus in blood donations.
As part of our early and ongoing communications with medical countermeasure developers to facilitate the development and availability of these critical products, the FDA gives regulatory advice, guidance, and technical assistance to sponsors developing investigational medical countermeasures for CBRN or emerging threat indications, to help facilitate development and availability of these important products. In 2018, for example, the agency issued indication-specific guidance to assist developers of medical countermeasures for smallpox and anthrax, and led more than 100 formal meetings with product sponsors. Moreover, FDA activities to advance innovative clinical trial designs—as part of our program to modernize drug development and promote innovation in drugs targeted to unmet needs—also support development and availability of medical countermeasures.
The FDA’s objective remains having safe and effective medical countermeasures available should they be needed. We continue to collaborate with medical countermeasure developers to move these products toward approval, but also to be prepared to enable access to them before approval, if needed, under an appropriate regulatory mechanism like an Emergency Use Authorization. Last year, the FDA enabled access to diagnostic tests—including for Ebola, Zika, and H7N9 influenza viruses—under this authority.
In FY 2018, FDA approved 28 medical countermeasures, including:
- The first drug with an indication for smallpox
- An auto-injector for chemical nerve agent preparedness
- The first test to screen for Zika virus in blood donations
The agency continuously strives to ensure its regulatory approaches are as modern and efficient as possible, as well as informed by the most up-to-date scientific understanding and advances. To promote innovation and help translate new technologies into safe, effective medical countermeasures, the FDA also continues to advance medical countermeasure regulatory science. These efforts support an important purpose—to fill critical science gaps that can challenge medical countermeasure development programs, which often already face unique development challenges, and ultimately delay the time it takes for these much-needed safe and effective resources to be available.
Along with regulatory responsibilities, and response to specific outbreaks, like the ongoing Ebola outbreak, the FDA collaborates closely with the U.S. Department of Health and Human Services, other federal agencies, and international partners, like the World Health Organization and international regulatory counterparts, to build and sustain the medical countermeasure programs necessary to prepare for and respond effectively to public health emergencies. The agency offers critical scientific and regulatory expertise through these collaborations, which are key because emerging infectious diseases know no geographical boundaries.
The FDA also works closely with the U.S. Department of Defense (DoD) to promote the development and availability of medical countermeasures to support the American military personnel’s unique needs. Last year, the FDA established a framework for enhanced collaboration with DoD under Public Law 115-92; the framework’s successful implementation is a high priority for the FDA. In FY 2018, the FDA issued an Emergency Use Authorization to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma for treating hemorrhage or coagulopathy of U.S. military personnel during an emergency involving agents of military combat; approved an atropine auto-injector for chemical nerve agent exposure; and, approved tafenoquine (Arakoda), the first prophylaxis indication for a new malaria drug in more than 18 years. The FDA continues to work closely with DoD, building on the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save American service members’ lives.
The FDA takes seriously the agency’s responsibility to help drive and advance innovation as part of protecting public health and national security. Progress over the last year—and success in the work that lies ahead—depends on the FDA’s dedicated staff, who work tirelessly to help protect the Nation from potential threats, and to promote public health both at home and around the world.