After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it's proposing a sweeping strategy to boost domestic drug production.
Under the plan, the White House is establishing a public-private partnership to select 50 to 100 essential medicines "to be the focus of an enhanced onshoring effort," the plan says. Further, the government is committing around $60 million to research new technologies to boost domestic API production.
The blueprint follows a February executive order demanding a multi-industry review of key American supply chains. The fact that much of America’s drug production is based overseas isn’t exactly news, but the pandemic put those problems into sharp relief.
While praising the speed of U.S. innovation that brought the world critical COVID-19 vaccines, the administration conceded that the country is “critically dependent on imports for a range of key pharmaceutical products and APIs,” which make up 90% of all prescription medicines filled in the U.S.
Meanwhile, some 87% of generic active pharmaceutical ingredient facilities are located abroad, leaving U.S. supplies of essential meds “vulnerable,” the administration said.
To start righting the ship, the administration has called on the Department of Health and Human Services (HHS) to establish a public-private consortium—leveraging the Defense Production Act and existing partnerships—to bolster the production of critical drugs on U.S. soil. To start, the consortium will identify 50 to 100 drugs from the Food and Drug Administration’s essential medicines list to prioritize.
Separately, HHS will invest around $60 million from the DPA appropriation in the American Rescue Plan to create “novel platform technologies” for domestic API production. The move could help safeguard American supplies of drugs in shortage, especially in the event of future crises, the administration said.
In addition to the $60 million commitment, the administration also calls for agencies to increase funding of advanced manufacturing technologies for drug and API production. The move would leverage both “traditional” manufacturing techniques, as well as “on-demand manufacturing capabilities for supportive care fluids, APIs, and finished dosage form drugs.”
The administration didn’t say what those advanced manufacturing approaches were, but recent actions by the FDA and other organizations like United States Pharmacopeia (USP) could hold clues. For years, the U.S.’ drug regulator has been pressing companies to adopt advanced manufacturing approaches like 3D printing and continuous manufacturing.
The last piece of Biden’s plan hinges on transparency. It calls for HHS to develop and make recommendations to Congress on new authorities that would help it track API sourcing, as well as production on a facility-by-facility basis. The move would also require the provenance for all drug ingredients and finished drug products to be identified on the label.