HHS to Expand US-Based Pharmaceutical Manufacturing for COVID-19

HHS recently announced that it will expand pharmaceutical manufacturing in the US to produce medicines needed during the COVID-19 pandemic and boost capacity for producing finished generic drugs.

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The COVID-19 pandemic has caused a significant increase in the number of hospitalized patients, which has created a shortage of supplies and critical medicines, HHS said. 

HHS will work with a team of private industry partners led by Phlow Corporation of Richmond, Virginia, to rapidly develop a list of active pharmaceutical ingredients (APIs) and finished medicines critically needed by healthcare systems for the COVID-19 response.

The team will provide hospitals and health systems with finished, sterile, injectable generic medicines at risk of shortage

The four-year $354 million agreement with BARDA, part of HHS, will allow Phlow to immediately respond to COVID-19, which will help decrease or prevent drug shortages during the pandemic. 

The contract can be extended up to $812 million over ten years to maintain systems and supplies, HHS said.  

“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,” HHS Secretary Alex Azar, said in the announcement. 

“America has the capabilities, resources, and expertise to secure our medical supply chains; now the Trump Administration is providing the leadership to make it happen. 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.”

Currently, many APIs are manufactured using slower, less efficient processes. Shipping the ingredients or finished drugs to the US adds time that is not available during public health emergencies, such as the current pandemic. 

The Phlow-led team will use advanced manufacturing processes, including continuous manufacturing, and will complete a technology transfer of continuous manufacturing processes to organizations designated by the government, HHS stated.

“BARDA is committed to working with partners from the private sector and across the U.S. government to improve our nation’s health security,” said Gary Disbrow, PhD, BARDA acting director. 

“Utilizing advanced manufacturing processes increases the speed we can provide patients with treatments, reduces the likelihood of drug shortages, and increases U.S. readiness. 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.”

HHS noted that the team’s mission is to secure the national supply of essential medicines through partnerships with pharmaceutical supply and manufacturing organizations. These organizations include AMPAC Fine Chemicals, Civica Rx, and the Medicines for All Institute at the Virginia Commonwealth University’s College of Engineering.

Civica Rx is a non-profit generic drug company that was established by hospital systems and philanthropies to alleviate drug shortages. 

The company provides 20 sterile injectable medications to over 1,200 hospitals that account for nearly 30 percent of all US hospital beds. Civica works with manufacturing partners and maintains an inventory reserve for many drugs that are used to treat COVID-19. 

These drugs include vancomycin, ketamine, lidocaine, fentanyl, and morphine, HHS said. 

Tom Kraus, JD, AHSP vice president of government relations explained in an emailed statement that using this new technology will enable faster production of drugs, reduce the potential for error, and allow for an efficient approach to changing market demands, including the dire need for medications during the COVID-19 pandemic. 

“ASHP has long advocated for actions that will support the preparedness and increase the resilience of the pharmaceutical sector's critical infrastructure,” Kraus stated. “We believe that this new agreement is a strong first step towards creating a safer, more reliable drug supply in the U.S.”