HHS Partners With US-Based Pharma Manufacturers to Address Shortages

The US Department of Health and Human Services (HHS) announced a plan to partner with a team of private industry partners in an effort to expand US-based pharmaceutical manufacturing, reducing the risk of shortages during the COVID-19 outbreak and potential future public health emergencies.

Phlow Corporation, Richmond, VA, will work with HHS to produce both active pharmaceutical ingredients (API) and the chemical compounds necessary to create those APIs in a new facility in Virginia. HHS and Phlow Corporation are working together to create a prioritized list of APIs and finished medicines deemed critical need by health care systems.

“The COVID-19 pandemic has reminded us how health threats or other sources of instability can threaten America’s medical supply chains, potentially endangering Americans’ health,” said HHS Secretary Alex Azar in a statement. “Working with the private sector, HHS is taking a significant step to rebuild our domestic ability to protect ourselves from health threats by utilizing American-made ingredients and creating new American jobs in the process.”

In order to reduce production costs, limit waste production, and yield considerable quantities of the APIs and finished medicines, the facility will implement continuous manufacturing and other advanced processes. HHS added in the press release that this collaboration will also consist of a technology transfer of novel continuous manufacturing process to organizations or businesses designated by the US government.

“Under the four-year, $354 million agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS,” the statement read. “The Phlow-led team will manufacture the supplies for medicines for patients hospitalized with COVID-19. The contract can be extended for up to a total of $812 million over a total of 10 years to maintain the system and supplies.”

“Utilizing advanced manufacturing processes increases the speed we can provide patients with treatments, reduces the likelihood of drug shortages, and increases US readiness,” said BARDA Acting Director Gary Disbrow, PhD. “Today we have taken an important step to strengthen our domestic drug production capability and respond to the increased need for medicines to treat COVID-19 patients during the current pandemic.”

This team effort also includes Phlow Corporations’ existing partnerships with AMPAC Fine Chemicals, Civica Rx, and the Medicines for All Institute at the Virginia Commonwealth University’s College of Engineering. —Edan Stanley