COMPLEX MISSION, CLEAR RESULTS
and in this same vein, an emergency use authorization, approved by the U.S. Food and Drug Administration (FDA) in June, made remdesivir available to both mili- tary members and the greater American public. Under the authorization, Gilead donated 500,000 doses of the treatment to the federal government to be distributed, ultimately, to hospitals for the purposes of dissemination to the American public either completely free of charge or at a reduced price.
“If you have or are diagnosed with severe COVID at a civilian hospital, it is avail- able through the EUA [emergency use authorization],” said Parriott, who addi- tionally handles the distribution, tracking and storage of the treatment allocated to the DOD under the emergency use autho- rization effort.
MANY MOVING PARTS Backing up for a second, it’s impor- tant to note that switching from one area of study to another doesn’t just happen immediately, or without substan- tial behind-the-scenes effort. In other words, USAMRDC efforts such as these simply can’t (and don’t) turn on a dime. In this specific case, the shift from using remdesivir as a potential Ebola medi- cal countermeasure to its current use as a COVID-19 treatment—as well as the aforementioned expanded access proto- col and emergency use authorization rulings—was the product of a process that required a unique and powerful set of legal and regulatory tools.
Indeed, for Jeremiah Kelly, who serves as chief of the FDA Regulatory Law Divi- sion, Office of the Staff Judge Advocate at USAMRDC, the process to create so-called “win-win” medical product development collaborations is similar in design to a well-choreographed dance routine.
30 Army AL&T Magazine Winter 2021
“Each one of these collaborations with our industry partners is unique, and each one is going to require a different set of legal solutions,” said Kelly. “And even within those legal solutions, it’s almost like a radio where you have to dial into the right station—the text that governs our relationship has to reflect the equities and goals of the partners. Tere is no one- size-fits all model.”
DANCE OF THE CRADA One of the tools at USAMRDC’s disposal is a type of contract known as a coopera- tive research and development agreement (CRADA). In short, a CRADA oper- ates as a research-and-development tool that enables federal laboratories to trans- fer or contribute government resources such as personnel, services and facilities to non-federal partners—with or with- out reimbursement, but (as a rule) with no funding from the organization to the partner—for the purpose of conducting research or development efforts consis- tent with the mission of the organization. On the other side, the non-federal collab- orating partner can transfer or contribute any resources to the federal organizations (including funding) toward those same research-and-development efforts.
“Te moment that we heard that remde- sivir had some activity against other coronaviruses, our legal team engaged with both our JPEO-CBRND and USAMMDA clients and Gilead via the CRADA mechanism to ensure that we could see the data and lay the groundwork to ensure DOD personnel would have access to this potentially effective therapy,” said Kelly, noting that the flexible nature of the CRADA enables USAMRDC to “get in the game” as early as possible. “We have so many requirements and so many capability gaps in the medical counter- measure space that the CRADA allows us to dance with whomever we want,”
said Kelly. “Te CRADA was the perfect legal tool to rapidly establish expanded access, with treatment courses guaran- teed to DOD personnel across the globe, and with the ability of our FHP team to obtain more from Gilead as needed.”
Te CRADA is further notable in that it essentially acts as a tech-transfer author- ity unto itself, something put into statute as part of the Stevenson-Wydler Technol- ogy Innovation Act of 1980. “It's a very rapid non-competitive capability where we can essentially decide how we want to do it,” said Kelly. “We can provide anything to a collaborator except money, which is why it's not competitive. And we can take in everything, including money to facili- tate any collaboration. So the nice thing about the CRADA is it can almost take any shape, so long as the government's not paying money to that collaborator."
FRONT LINES
Lt. Col. Sandi Parriott was interviewed during a taped video presentation as part of USAMRDC’s contribution to the 2020 Annual Meeting and Convention of the Association of the U.S. Army (AUSA), which was held virtually in October. (Video image courtesy USAMRDC Public Affairs)
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