The Ebola epidemic in West Africa is the worst medical outbreak of the disease in recorded history. Currently, there are no treatments or vaccines proven to be safe or effective for the Ebola virus, and investigational vaccines and treatments are only in the early stages of development. As such, the primary approach to containing the virus includes identifying and isolating infected people, and ensuring that health care workers have access to protective equipment.
In response to the Ebola outbreak, the U.S. government has been actively working with private and public entities and international organizations to facilitate the development of treatments and vaccines with the potential to help mitigate the Ebola epidemic. Additionally, the U.S. Food and Drug Administration (“FDA”) has utilized a mechanism under its regulatory framework to enable access to an investigational medical product that can detect the Ebola virus.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C), the FDA can issue an Emergency Use Authorization (EUA), which allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives. The FDA recently utilized an EUA to authorize the use of an Ebola diagnostic test, developed by the Department of Defense (DOD). The FDA declared that the DOD’s diagnostic test could help facilitate an effective response to the ongoing epidemic in West Africa by rapidly detecting patients infected with Ebola virus, and facilitating appropriate containment measures and clinical care. After the issuance of the EUA, the FDA encouraged other diagnostic product developers to pursue an EUA, or other appropriate mechanisms, for their investigational products that can be used to test for or treat Ebola. Although the EUA issued October 10, 2014 waived certain labeling, storage, and distribution requirements, developers should be mindful that section 564 of the FD&C Act does not establish a liability protection scheme or tort immunity for manufacturers or others who carry out any activity for which an EUA is issued.
In addition to the FDA’s authority to issue EUAs, the Public Readiness and Preparedness Act (PREP) authorizes the Secretary of the U.S. Department of Health and Human Services (HHS) to issue a PREP Act declaration in response to a public health emergency. Unlike an authorization under an EUA, a PREP Act declaration provides immunity from tort liability claims to individuals or organizations involved in manufacturing, distributing, or dispensing medical countermeasures. Covered countermeasures include vaccines, antidotes, medications, medical devices or other FDA-regulated products used to respond to pandemics, epidemics, or any biological, chemical, radiological, or nuclear threat. If HHS chooses to issue a PREP Act declaration for the Ebola virus, manufacturers who decide to distribute or dispense medical countermeasures under a declaration should be advised of the liability protections they can receive.