MCS Instrumental in EUA Approval of Nerve Agent Autoinjector
(Originally published online at Military Medical News: http://www.militarymedical.com/?p=16995)
In April, the U.S. Department of Health and Human Services (HHS) signed a declaration authorizing emergency use of injectable treatments to counter effects of nerve agents and certain insecticide poisoning. The Chemical Defense Pharmaceuticals (CDP) product management office within the Department of the Army’s Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) provided atropine in autoinjectors to protect military service members and first responders under this authorization.
HHS concluded that there is substantial potential for a public health emergency involving nerve agents and certain insecticides. The usage of these agents can affect national security as well as the health and security of U.S. citizens living abroad.
The Food and Drug Administration (FDA) authorizes use of an unapproved drug or unlicensed biological product in cases of threats to civilians and militaries. Emergency Use Authorization (EUA) authority is a legal mechanism that enables the FDA to strengthen the nation’s public health readiness against potential chemical, biological, radiological, or nuclear (CBRN) events.
In this case, the Centers for Disease Control and Prevention (CDC) requested the EUA to support preparedness for possible public health threats but not as a response to a specific incident. Thus, the FDA authorized the use of a 2mg atropine autoinjector, a drug which treats the symptoms and effects of nerve agent attacks and certain pesticide poisonings.
Approximately 95% of the current FDA-approved autoinjectors are set to expire within the next five years, and the commercial market has limited capability to replenish the Strategic National Stockpile housed at the CDC. Pending the availability of such products, the EUA ensures that the devices are available and rapidly administered in the event of a public health emergency. This further enables the DoD to mitigate risks related to autoinjector manufacturing by diversifying its contract portfolio.
The Chemical Defense Pharmaceuticals product management office was able to respond to the EUA through its contract with Rafa Laboratories Ltd., an Israeli firm that works through U.S. sales and distributions, to manufacture atropine autoinjectors. As of August 2017, Rafa is manufacturing the products, which allows U.S. government agencies, including the DoD, the capability to procure the device in advance of full FDA licensure.
“Emergency Use Authorization for use of products like atropine autoinjectors is vital to protecting our Service Members and civilian populations from the frightening and lethal effects of nerve agents like soman,” said LTC Matthew Clark, Joint Product Manager for CDP.
He added, “We at Chemical Defense Pharmaceuticals are always looking for ways to be more cost-effective and efficient in our product development. By partnering with other pharmaceutical companies like Rafa, we are increasing competition within the federal acquisition process and driving down costs, which ultimately benefits U.S. taxpayers. The approach also ensures the readiness of our military and civilian first responders to respond to this deadly threat.”
MCS was heavily involved in the pre-EUA process, actively participating in DoD pre-event planning and preparedness activities. MCS further provided the CDC with referenced data from Rafa, which was essential to submit the EUA, and lent regulatory and technical expertise to the CDC as they prepared their EUA submission.
Additionally, MCS contracted Ology Bioservices (formally Nanotherapeutics) to provide regulatory support as the U.S. agent for the device, acting as a liaison between the FDA and Rafa.
Ology Bioservices also manages the DoD-owned Advanced Development and Manufacturing (ADM) facility in Alachua, Florida, a Biosafety level 3 (BSL-3) certified manufacturing facility that enables researchers and scientists to work with microbes which can cause serious and potentially lethal disease via inhalation. The ADM provides the DoD with the capability to support medical countermeasure development from research through licensure.
The DoD, MCS, and CDP anticipate these relationships to expand to support additional urgent DoD requirements for other medical countermeasure autoinjectors. The effort to achieve an EUA approval and procure atropine autoinjectors highlights the collaborative approach between U.S. government agencies to rapidly respond to CBRN threats and mitigate risks associated with limited product supplies.