President Biden announced that in May 2023, the U.S. will officially end its emergency response posture to the COVID-19 pandemic. This announcement marks a significant milestone in a long and difficult journey. From masks, to at-home test kits, to vaccines, countless experts worked tirelessly behind the scenes to develop the products and solutions that allowed the country to move forward and reinvigorate the supply chain. Among these experts were lawyers.
All the products developed or acquired that allowed the country to bolster the supply chain, were due in large part to a group of attorneys who worked tirelessly to understand an unprecedented issue, create ways for the government to develop lawful partnerships to safely execute the projects needed to move the country forward, and do these things quickly.
In May 2021, the Defense Department (DoD) and U.S. Department of Health and Human Services (HHS) signed a Memorandum of Understanding (MOU) to formalize the DoD’s acquisition support, led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), to the HHS’ COVID-19 response mission.
As part of the MOU, the Joint Assisted Acquisition (JA2) team was created to work alongside the Army Contracting Command’s (ACC) Joint COVID Response Division to organize and lead the necessary legal support to face the unprecedented challenges of the COVID-19 pandemic and a unified government response.
More than $76 billion worth of COVID-19 vaccines, therapeutics, and diagnostics acquired by the U.S. government and countermeasures developed in response to COVID-19 were reviewed, negotiated, or in some way crossed the desks of JA2 legal personnel.
The JA2 Legal Cell was comprised of attorneys from various Army organizations including ACC, U.S. Army Medical Research and Development Command (USAMRDC), the U.S. Army Combat Capabilities Development Command Chemical Biological Center (DEVCOM CBC), the U.S. Army Combat Capabilities Development Command Soldier Center, and U.S. Army Communications-Electronics Command (CECOM).
The legal team had experts in a variety of fields: sophisticated research and development acquisition, intellectual property, U.S. Food and Drug Administration (FDA) regulatory law, technical data rights, construction law, fiscal law, federal grant and cooperative agreement law, technology transfer law, human subject protections, and other legal specialties.
Each attorney provided keen attention to detail and often, needed to work quickly to meet deadlines that sometimes required simultaneously soliciting, negotiating, and awarding dozens of contracts in timeframes as short as two weeks.
“Every member of the legal cell recognized the importance of the mission. We had to work fast, think creatively, and try different approaches to establish effective collaborations with contractors to get the needed tools out to the public to fight the public health emergency,” said Rachel Hunnicutt, Acting Chief, FDA Regulatory Law Division with the Office of the Staff Judge Advocate at USAMRDC.
“Having a range of legal experts ensured there was always someone who had the answer or could find the answer. What impressed me most was seeing all attorneys act selflessly, tirelessly, and truly function as one legal cell on behalf of the U.S. government,” added Hunnicutt.
The range of specialties was important as the team needed to use various contract types to get the job done, often leveraging non-traditional avenues. True partnership and teamwork were keys to success. The team, which worked remote, had to trust each other when it came to research and navigating new methods. The team developed strong working relationships and trusted friendships as a result this effort.
“Before joining the legal support team for JA2, I was under the impression that the government acquisition process was like molasses. Apparently, I had been misled,” said Jake Stein, Attorney-Advisor with the Office of the Staff Judge Advocate at USAMRDC.
“The entire JA2 team, including legal, was made up of dedicated public servants willing to put in every ounce of energy needed to support each other so that we could support the American public. There was such an incredibly high level of expertise and depth of experience on the team that inspiration, creativity, and collaboration flowed effortlessly,” Stein said.
The team’s accomplishments included more than 2,500 separate legal actions, including awards in support of Operation Warp Speed for various industry partners; support to Operation Expanded Testing, Industrial Base Expansion Mission, and Capability Expansion; and vaccine acceleration programs, including the B.A. 4/5 Variant Fall 2022 Booster Campaign, global vaccine donations, and fulfilling the emergency acquisition of one billion COVID diagnostic kits.
“I have the utmost respect and gratitude to our legal team. We had the best and brightest on our side and there is no way that we could have supported our Nation through this pandemic without that group of experts assisting us each step of the way,” said Nicole Kilgore, Deputy Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. “Their efforts started a precedent that I’m sure others will follow.”
Ms. Kilgore and Mr. Darryl Colvin, Joint Program Executive Officer for CBRND, formally recognized the Legal Cell for their service and commitment to the JA2 mission with Certificates of Appreciation and the JA2 Commander’s Coin at a recognition ceremony earlier this year.
The JA2 Legal Cell’s work paved the way for the successful development and deployment of vaccines, therapeutics, diagnostics, and every countermeasure developed in response to COVID-19. Their efforts demonstrate the importance of legal expertise in addressing complex and unprecedented issues like a global pandemic. The blueprint the JA2 Legal Cell laid out in support of the COVID-19 pandemic response will undoubtedly serve as a guide for similar future efforts.