Regulatory Overview and Considerations for Medical Countermeasures Developed for Radiological/Nuclear Incident Responses.

After the terrorist attacks on September 11 and the anthrax attacks in 2001, the United States Government (USG) implemented several pieces of legislation to enable the federal government to prepare for future threats, including managing and funding product development of medical countermeasures (MCMs). The Project BioShield Act of 20041 and the Pandemic and All Hazards Preparedness Act (PAHPA) of 20062 (with reauthorizations in 20133 and 20194) described and fine-tuned the scope and mission of different agencies in this effort. The Department of Homeland Security is charged with issuing material threat determinations5 from which organizations can model threat scenarios to determine potential health outcomes. The numbers from these models serve as thresholds for planning purposes. Within the radiological and nuclear (Rad/Nuc) space, there are two primary threats that have been identified as threats to national security: nuclear detonation (NucDet) and radiological dispersal devices (RDDs). NucDet is deemed the higher priority threat for planning and MCM development because of its greater potential impact. Health effects associated with nuclear power plant accidents are also considered in planning and preparedness.