ARMY AL&T
The program team delivered more than one capability, treatment and prophylaxis, with a device that can serve both military and first responders around the world.
Te team used the middle-tier pathway by identifying nalox- one as the “gold standard” for treating an opioid overdose. Te FDA had approved the use of up to 10 milligrams of naloxone as a safe and effective way to treat opioid overdose. A 2 mg nalox- one autoinjector was already commercially available but did not meet military requirements for treatment of highly potent opioids (e.g., carfentanil) and provided electronic voice instruc- tions for civilian patients, unnecessary in a combat situation. In addition, DOD science and technology organizations had deter- mined through animal studies that a single 10 mg dose would allow rapid treatment of high-potency opioids on the battlefield or in other scenarios requiring rapid countermeasures, while also allowing exposed individuals to retain mobility and survive the initial exposure and evacuate to a higher echelon of medical care.
REGULATIONS, REGULATIONS, REGULATIONS Next, the program team developed a regulatory strategy to receive FDA approval of the 10 mg naloxone autoinjector. A regulatory strategy captures the necessary information required to demon- strate safety and efficacy of the product. Using Public Law 115-92, the team met with the FDA to gain feedback. Public Law 115-92 authorizes the FDA to provide DOD assistance to expedite the development and review of products that could diagnose, treat or prevent serious or life-threatening diseases or conditions facing U.S. military personnel. If the FDA recognizes that priority presented by DOD is needed, this can result in critical medical products getting to the warfighter faster. Te feedback from the FDA provided validation that the program would be able to meet the five-year timeline for middle-tier acquisition.
LEADING THE WAY To set the program up for success, the program team conducted market research to identify candidates that could be repurposed for a 10 mg naloxone autoinjector. Te team also needed to
CLOSE UP
Rapid Opioid Countermeasure System naloxone autoinjector. (Photo courtesy of Kaléo Inc.)
know if there were companies that already were producing FDA- approved autoinjectors that met the newly updated and stringent engineering and quality requirements.
Having to seek FDA approval for a new autoinjector would require costly studies, which would dramatically increase the develop- mental cost and schedule. Te program team conducted online research, contacted potential performers using requests for infor- mation, and canvassed the Medical CBRN Defense Consortium and an other-transaction authority agreement consortium.
To further accelerate product development, the program team needed a flexible contracting mechanism that was mutually beneficial to both the government and industry partners. Using other-transaction authority promoted increased competition by
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