Under the Project BioShield (PBS) Act (2004) (PDF - 191 KB) and the Pandemic and All-Hazards Preparedness Act (2006) (PDF - 248 KB), BARDA was charged with developing medical countermeasures (MCMs) to address chemical threats to the United States determined by the Department of Homeland Security (DHS) as Material Threats. DHS has issued a material threat determination covering nerve agents and cyanide chemical threats included in their Terrorism Risk Assessment. BARDA’s Chemical Medical Countermeasures (MCM) Program supports advanced development of MCM candidates and interventions to address these high priority chemical threats. The Chemical MCM Program focuses on advanced development of decontamination treatments for mass exposure, post-exposure antidotes and non-pharmaceutical interventions for chemical exposure, including novel and repurposed therapeutics. A major area of emphasis is development of scientifically-valid guidance suitable for first-responders working on mass casualty decontamination after a chemical event. Decontamination quickly reduces chemical exposure levels and absorbed doses, and also protects responders, medical providers and medical facilities to secondary exposure and contamination. A second emphasis area is the repurposing, or label expansion, of drugs already in common use in hospitals and the community. Repurposing drugs to make them available where and when they are needed in a chemical event will reduce our reliance on centralized stockpiles or logistically-challenging forward deployment programs.
A major accomplishment of the Chemical MCM program was the acquisition under Project BioShield in 2013 of midazolam (an anti-convulsive drug) to replace diazepam in the CDC’s CHEMPACK program, which strategically stores nerve agent antidotes in U.S. localities that can be accessed quickly in response to chemical events. BARDA is supporting FDA approval of midazolam for use in the pediatric population and the procurement of pediatric-dose auto-injectors. Delivering these MCMs to the Strategic National Stockpile by 2018 will significantly enhance CHEMPACK capabilities for responding to children during chemical events. BARDA-supported FDA approval of intramuscular midazolam for emergency treatment of prolonged seizures in children and adults will ensure that this vital MCM is widely available to first-responders even when a CHEMPACK is not readily accessible. A second major accomplishment was the publication of decontamination guidance on Primary Response Incident Scene Management (PRISM). Decontamination of individuals exposed to chemical agents is the single most effective way to decrease the negative health impacts of exposure to chemical agents.
In addition to midazolam, BARDA is supporting advanced development of six (6) chemical MCM candidates, including repurposed therapeutics (such as Silverlon® burn dressing) for vesicant-induced skin injuries and ketamine for treating nerve agent-induced seizures. Silverlon®development is a collaborative effort between the Chemical and Burn MCM programs, affording BARDA the opportunity to leverage investments in products that can be used in response to more than one material threat. Further leveraging of investments is being done through collaboration with the new National MCM Response Infrastructure, which is facilitating evaluation of several other commercially available drugs for their ability to effectively mitigate injuries resulting from exposure to chemical agents.
BARDA will continue working with PHEMCE partners to transition promising new and repurposed chemical MCM candidates from early to advanced research and development, and from advanced development toward FDA approval and acquisition under Project BioShield. BARDA will expand future efforts to improve health outcomes for all victims of chemical exposure by continuing to enhance response capabilities and standards of care, and by supporting development and procurement of new and better therapeutic interventions. We look forward to receiving new candidates for the Chemical MCM Program—this is a high priority with great interest to BARDA.