“While the World Health Organization declared smallpox eradicated in 1980, concerns have persisted that smallpox could be used as a biological weapon. The FDA plays a pivotal role preparing our nation to be able to protect the American people from biological threats, including by providing guidance and support for the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.
“We work with government partners as well as non-government organizations, universities and research centers, and industry to further the development of medical countermeasures as part of our vital public health mission. Despite recent advances in developing an effective treatment for smallpox, drug developers still face challenges in bringing forward these medical countermeasures, which are critical should smallpox ever be used as a biological weapon. The agency’s work to advance safe and effective medical countermeasures is a high priority, and today’s final guidance on the development of drugs to treat or prevent smallpox builds upon currently available guidance, further advancing the agency’s long-standing commitment to the development of robust medical countermeasure preparedness efforts.”
On November 15, 2019, FDA issued final guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention, which is designed to assist drug manufacturers designing studies to appropriately establish the safety and efficacy of drugs to treat or prevent smallpox infection.