HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.
The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.
The White House briefing statement said: “The United States remains critically dependent on imports for a range of key pharmaceutical products and active pharmaceutical ingredients—the primary ingredients of generic drugs.”
During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.
“This program will ensure timely availability of essential domestic industrial resources; establish the necessary authorities and mechanisms to leverage the proposed Supply Chain Resilience and Crisis Response Office for management of the public health industrial Base; support extended long-term contracts, on-hand inventory, and vendor-managed inventory; and ensure sufficient manufacturing capacity,” the White House said.
An accompanying capstone report mentioned specific steps that HHS has taken to boost the production of APIs. They include a partnership with the Defense Advanced Research Projects Agency and the U.S. Air Force that involves two efforts to advance technologies and processes for drug substance and final dosage form production. The projects encompass the advanced continuous synthesis of APIs, reducing the footprint of production facilities, and modular and distributive drug manufacturing.
According to the White House report, HHS has invested more than $105 million to advance chemistries and process development for continuous production of active pharmaceutical ingredients (APIs) including dexmedetomidine, rocuronium and fentanyl. Said the report: “Construction of a new current good manufacturing practice facility was completed, and will support manufacture of sterile injectable analgesics and sedative medications, including midazolam, propofol and cisatracurium.”
Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.
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