The US Department of Health & Human Services (HHS) announced the start of their partnership with private industry members led by Phlow Corporation in order to increase US manufacturing of active pharmaceutical ingredients (APIs) needed to produce essential medicines during the coronavirus disease 2019 (COVID-19) pandemic.1
The team will provide “immediate, US-based capacity” to produce critical medicines, including those for the pandemic response, to help alleviate or prevent drug shortages.1
According to its website, Phlow was formed to “manufacture low-cost, high-quality, essential generic drugs for the United States.” The contract will help it contribute to the national stockpile of pharmaceutical ingredients for generic drugs.
The 4-year $354 million contract with the Biomedical Advanced Research and Development Authority (BARDA) will initiate the domestic manufacturing of APIs, including erecting a new facility in Virginia. Currently, these pharmaceutical ingredients are primarily made abroad using “slower, less efficient processes,” the HHS news release said.1
HHS and Phlow, which has assembled a manufacturing team consisting of AMPAC Fine Chemicals, Civica Rx, and the Medicine for All Institute at the Virginia Commonwealth University’s College of Engineering, intend to implement advanced manufacturing processes, including continuous manufacturing, to “lower production costs, reduce waste and improve yields of these ingredients.”1
Shifting manufacturing to the United States also alleviates time constraints associated with quickly and efficiently treating patients with COVID-19, and would protect the US national medical supply should some countries close their borders in response to the global health emergency, according to the news release.1
The team has been developing a list of APIs and finished medicines needed to treat hospitalized patients with COVID-19, including those that are used in conjunction with ventilator support, pain management medications, and some antibiotics.1,2
Phlow is additionally building the United States’ first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to create secure supplies of the most essential generic medicines and effectively focusing on moving away from US foreign dependence within the pharmaceutical supply chain.3
“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. “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.”1
According to the release, 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.1
1. HHS, Industry Partners Expand U.S.-Based Pharmaceutical Manufacturing for COVID-19 Response. News Release. HHS; May 19, 2020. Accessed May 20, 2020. https://www.hhs.gov/about/news/2020/05/19/hhs-industry-partners-expand-u....
2. Gay S. Trump to Tap New Company to Make Covid-19 Drugs in the U.S. The New York Times website. https://www.nytimes.com/2020/05/18/us/politics/trump-coronavirus-drug-ma.... Published May 18, 2020. Accessed May 20, 2020.
3. Phlow Corporation Awarded $354 Million HHS/ASPR/BARDA Contract to Manufacture Essential Medicine in Shortage. News Release. PR Newswire; May 19, 2020. Accessed May 20, 2020. https://www.prnewswire.com/news-releases/phlow-corporation-awarded-354-m...