November 15, 2019

Media Inquiries

  Kristen Pluchino
  240-402-0861

“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.”

The U.S. Food and Drug Administration today 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.

Although smallpox was declared eradicated in 1980, concerns exist that it could remain in unknown locations or used as a biological weapon. Routine smallpox vaccination in the U.S. was discontinued in the 1970s, and because there is no natural disease exposure, most of the U.S. lacks immunity to smallpox, which leaves the population particularly vulnerable. Because of the unique complexities of drug development in this area, the FDA has been involved in extensive discussions with multiple stakeholders, including a public workshop in 2009 and an Advisory Committee meeting in 2011, which helped formulate the regulatory pathway for smallpox drug development described in this guidance. This guidance finalizes draft guidance issued on July 11, 2018, which revised draft guidance issued on November 23, 2007. This final guidance clarifies the recommended immunological characterization of animals in key studies and includes minor editorial changes from the draft.

The FDA plays a critical role in protecting the U.S. from chemical, biological, radiological, nuclear and emerging infectious disease threats, including facilitating the development of safe and effective medical countermeasures to diagnose, treat and prevent deadly infections, developing guidance for industry, holding Advisory Committee meetings to discuss medical product development, monitoring for fraudulent products and false product claims and taking appropriate action to protect consumers.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products