Plans for mass distribution of medical countermeasures raise challenging problems, including legal and regulatory issues. Many in the distribution chain have expressed concerns over the potential for liability when countermeasures are distributed in accordance with large‐scale response plans. This is of particular concern if the medical countermeasure involved has not been approved, cleared, or licensed by the US Food and Drug Administration (FDA). This article discusses legal and regulatory options for countermeasure distribution that address liability concerns and access to unapproved countermeasures during an emergency.

No abstract