In a recent U.S. Government Accountability Office (GAO) report to Congress, GAO identified additional information that lawmakers may find useful as they consider the U.S. Department of Defense’s (DOD) public-private partnership for its advanced development and manufacturing (ADM) facility.
ADM facilities provide a flexible capacity to rapidly produce medical countermeasures for a number of threats, including novel naturally-occurring emerging infectious diseases and various bioterrorism agents.
According to GAO, the DOD had long expressed concerns about its ability to construct and manufacture medical countermeasures against biological warfare agent threats and endemic diseases.
In 2013, the DOD partnered with a private sector biopharmaceutical company to develop an ADM facility with the capability to use disposable equipment enabling timely changes in a production line for medical countermeasures, which went operational in March 2017 and included an option for renewal in two-year increments through 2024.
In order to provide a layer of oversight, Congress included a provision in the FY2016 National Defense Authorization Act (NDAA) that DOD submit a report to lawmakers addressing a number of required elements regarding the ADM facility. The report was officially sent to Congress in October 2016.
Elements of the DOD report included a description of the facility’s capabilities; information on program goals, high-level performance metrics, and program cost; a copy of a 2009 analysis of alternatives that justifies the ADM capability; an independent analysis of the incremental costs and benefits; and the department’s medical countermeasure production plans for the facility.
The GAO report identified additional information that may be useful for congressional oversight, particularly as it related to whether or not the DOD would renew its contract for the two-year option periods with the facility’s private contractor.
First, the DOD’s sustainment payments for priority access to the ADM capability will be budgeted as a cost of developing medical countermeasures, which is similar to how DOD operates within its own laboratories.
GAO also indicated that the total costs to the ADM capability contractor, which include costs to operate and maintain the facility, were not fully known at the time of DOD’s October 2016 report and were not fully covered by DOD-provided sustainment payments.
Additionally, the report found that three U.S. Department of Health and Human Services (HHS) facilities were not analyzed as alternatives to the DOD ADM facility, even though HHS officials stated that DOD could separately contract for medical countermeasures with any of HHS’s facilities through existing department contracts or independently.
The GAO report included no recommendations to the DOD at this time.