New Legal Authorities for BARDA Industry Day Initiatives

This article was written as part of a partnership with Steptoe, LLC.

At its recent Industry Day on November 13 and 14, 2023, the Biomedical Advanced Research and Development Authority (BARDA) identified three initiatives that it plans to support with new legal authorities.

• First, BARDA is making efforts to strengthen U.S. supply chains to ensure that materials and services are available for essential medical countermeasures in the event of a future pandemic or national emergency.
• Second, BARDA is taking steps to establish a medical countermeasure industrial base that stands ready to support biodefense in the United States.
• Third, BARDA is expanding its use of “other transaction authority” (OTA) agreements to streamline awards through two new consortia, which BARDA also hopes will support rapid procurements on a sole-source basis under a new contracting authority that it is currently seeking from Congress.
  
  

These initiatives are expected to expand opportunities to engage with BARDA and receive funding for biodefense. In addition, new legal authorities that support these initiatives will likely streamline the contracting process and reduce burdens on funding recipients.

For example, BARDA is now taking a holistic view of the entire supply chain for medical countermeasures, which will likely create new funding opportunities for contract manufacturing organizations and suppliers of raw materials and intermediates. BARDA is also focused on establishing an industrial base, which will likely result in at least some funding awards being made for expansions or even reservations of production capacity in the United States. BARDA intends to increasingly rely on OTAs, meaning more organizations will likely be willing to work with the authority because OTAs are not subject to many of the burdensome compliance obligations that are typically associated with U.S. government awards.

The White House recently took a step to support BARDA’s efforts by issuing a determination under the Defense Production Act on December 27, 2023, which designates certain medicines, medical countermeasures, and inputs as essential to national defense. As a result, BARDA and other agencies can now be granted authority to bypass typical contracting rules in making awards, such as restrictions on funding construction, making payments or purchase commitments in advance, and issuing awards without competition. For example, the determination could support expansions of mRNA production facilities or even advance purchase commitments for products before they receive a marketing authorization for a particular indication.

BARDA is also pursuing an expansion of its OTA authority to permit it to procure products or services on a sole-source basis after initially providing funding for small-scale trials or prototypes. The U.S. Department of Defense (DoD) already has this authority, and BARDA relied on the DoD to use its authority during the COVID-19 pandemic to make large purchases on an expedited basis. BARDA is now seeking to recreate this success through its own version of the DoD’s authority, which suggests that BARDA is serious about rethinking how it works with industry to promote biodefense, especially when considered with its commitment to look at supply chains more broadly and increasingly leverage OTAs.