HHS to shore up domestic production of medications and APIs

June 9, 2021

Under the Defense Production Act, the Department of Health and Human Services (HHS) will establish a public-private consortium for advanced domestic manufacturing of essential medicines and active pharmaceutical ingredients, or APIs.

The consortium’s first task will be to select 50-100 critical drugs, drawn from the U.S. Food and Drug Administration’s(FDA) essential medicines list, to be the focus of an enhanced onshoring effort. HHS plans to invest $60 million initially in the effort.

The work of HHS is part of a strategy announced by the White House to strengthen the U.S. supply chain across multiple manufacturing sectors. The strategy follows findings released from a comprehensive 100-day supply chain assessments for four critical products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

The goal is to complete the supply chain strategies within a year.

”Last year the American people experienced a widespread and significant shortage of N95 respirators for healthcare workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” said FDA Acting Commissioner Janet Woodcock, MD. “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”

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