HHS Takes an Important Step to Form a Biopharmaceutical Manufacturing Preparedness Consortium to Expand Domestic Biopharmaceutical Manufacturing Capability

The Biomedical Advanced Research and Development Authority (BARDA), an office the Department of Health and Human Services (HHS), recently announced¹ that it is seeking to partner with a Consortium Management Firm (CMF) to form a Biopharmaceutical Manufacturing Preparedness Consortium (BioMap-Consortium) comprised of pharmaceutical, medical, academic, and scientific companies and other organizations from across the drug and vaccine manufacturing supply chain. BARDA indicated in 2021 that the office was considering establishing such a consortium² and partnering with a CMF would be an important step forward in that effort.

BARDA is leveraging its Other Transaction Agreement (OTA) authority to partner with a CMF and to help establish and manage the BioMap-Consortium. OTA authorities allow certain agencies to enter into agreements with companies and other nongovernmental actors that are exempt from certain government contracting requirements and restrictions. Agencies may leverage their OTA authorities to establish flexible and strategic consortiums and other partnerships between government and industry. OTA authorities have been leveraged effectively to establish consortiums in similar contexts. The Medical CBRN³ Defense Consortium (MCDC), for example, established by the Department of Defense (DoD) through DoD’s OTA authority, has allowed DoD to partner with the private sector to advance various development efforts supporting DoD’s medical pharmaceutical and diagnostic requirements, including funding and helping implement COVID-19 vaccine development and delivery operations as part of Operation Warp Speed.⁴

The overall goal of the BioMap-Consortium initiative is to expand domestic U.S. manufacturing capabilities by creating a mechanism for fast and flexible access to commercial biopharmaceutical manufacturing platforms and innovative technologies, which can transition rapidly to respond to future public health emergencies. The BioMap-Consortium would be supported by BARDA, both strategically and financially, and would focus on domestic investments and projects. While the BioMap-Consortium initiative is particularly focused on preparing for future pandemics and other such public health emergencies, HHS has noted that the initiative aligns with several broader U.S. government objectives to shore up the U.S.’s bio-preparedness and public-health-related industrial base and supply chains, including Biden Administration Executive Orders (E.O.s) 14001, “E.O. on a Sustainable Public Health Supply Chain” (Jan. 21, 2021),⁵ and 14017, “E.O. on America’s Supply Chains” (Feb. 24, 2021).⁶ Both E.O.s, in important part, focus on improving the resiliency, diversity, and security of the U.S.’ medical product manufacturing capabilities and supply chains, with a goal of helping prevent, reduce, or mitigate shortages of key medical products.

Notably, the BioMap-Consortium initiative arises out of a program, now being sunset by HHS, that had been in place since 2012 called the Centers for Innovation in Advanced Development and Manufacturing (CIADM). The CIADM had been similarly tasked with improving domestic infrastructure and expertise to produce medical countermeasures in response to public health emergencies, but ran into difficulties when called on during the COVID-19 pandemic to produce medical countermeasures at a large scale. An internal HHS review later determined that CIADM sites had been significantly underutilized prior to the COVID-19 pandemic and that a lack of regular manufacturing work from either HHS or other manufacturers had prevented the sites from developing the capability to rapidly produce public health emergency countermeasures at the scale envisioned by the program.⁷ From a broader perspective, the experience of the CIADM program is just one example of how, as is noted in a recently issued Senate report on drug shortages, “the COVID-19 pandemic laid bare the longstanding vulnerabilities within the U.S. pharmaceutical supply chain.”⁸

Increased investment and focus on biopharmaceutical manufacturing and supply chains through the BioMap consortium, even if highly focused on manufacturing operations, products, and supply chains that could be mobilized or reserved to combat future pandemics and other such public health emergencies, may serve an important role — whether through spill-over effects, improving core manufacturing and supply chain infrastructure, or otherwise — in helping prevent, reduce, or mitigate biopharmaceutical product shortages in the U.S. Considering the inherent unpredictability of future pandemics and other future public health emergencies, an effective and efficient medical product production and supply program would need to be prepared to adapt and pivot to manufacturing and supplying different biopharmaceutical products, as needed, to address the specific pandemic or other public health emergency we find ourselves confronting.

BARDA’s efforts to establish the BioMap-Consortium occur against a backdrop of a range of private and public sector efforts to strengthen domestic drug manufacturing and supply and to prevent, reduce, or mitigate drug shortages. Various pieces of legislation on these issues have recently been introduced, such as the Senate “Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act” (S. 2510, introduced July 26, 2023), which would seek to establish a program to improve supply chain resiliency for critical generic drug products, and the Senate “Mapping America’s Pharmaceutical Supply (MAPS) Act” (S. 2364, introduced July 18, 2023), which would require HHS to map vulnerabilities in the pharmaceutical supply chain. The U.S. Food and Drug Administration (FDA) also continues to take efforts to help prevent, reduce, or mitigate drug shortages, including issuing draft guidance earlier this year to implement CARES Act requirements related to drug shortages⁹ and through the day-to-day hard work of the agency’s drug shortage staff. The private sector has also made various efforts to help prevent, reduce, or mitigate drug shortages. The Association for Accessible Medicines (AAM), for example, which represents manufacturers and suppliers of, or associated with, generic drug products, recently issued a white paper on “Drug Shortages: Causes and Solutions” (June 2023).¹⁰ The white paper includes recommendations related to ensuring a sustainable generic drug market, increasing reserves of critical medicines, improving manufacturing capacity, and reducing regulatory and manufacturing challenges. Similarly, Pharmaceutical Research and Manufacturers of America (PhRMA), which represents manufacturers of brand-name drugs, recently issued a report highlighting its members’ efforts to build up advanced biopharmaceutical manufacturing and supply chains in the U.S.¹¹

Drug and biologics manufacturers interested in potentially joining the BioMap-Consortium should watch for developments in this space and for related announcements from HHS and BARDA. Joining the program may present opportunities to work with key HHS policymakers on important public health and biopharmaceutical industry issues and to improve domestic drug and biologics manufacturing and supply programs. For companies or other organizations interested in serving as the CMF for the BioMap-Consortium, applications are due to HHS by August 22, 2023.

We will continue to monitor developments in this space. If you have any questions about the content discussed here or would like more information, please feel free to reach out to one of the authors of this Advisory or to your existing Arnold & Porter contact.

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