President Joe Biden on Sept. 12 signed an executive order launching the National Biotechnology and Biomanufacturing Initiative, noting that the United States relies heavily on foreign materials and foreign bioproduction. Offshoring of critical industries threatens nations’ ability to access materials such as critical chemicals and active pharmaceutical ingredients.
Consider the prescriptions you or your loved one may need for high blood pressure, infections, or other ailments.
In fact, in 2021 the White House sounded the alarm about vulnerabilities in the pharmaceutical supply chain. A White House report declared that “the disappearance of domestic production of essential antibiotics will undermine our ability to combat threats ranging from pandemics to bioterrorism.”
A lack of manufacturing capacity in the US due to offshoring was the main culprit. But a new study from the University of Washington at Olin Business School’s St. Louis Center for Analytics and Business Insights (CABI) shows that while the United States does have the capacity to manufacture some of the nation’s most important and important pharmaceuticals, most is abandoned.
Reports fill important data gaps
The CABI report, “US Generic Pharmaceutical Manufacturer Available Capacity Research Survey,” fills critical gaps in available industry data.
Anthony Sardella, author of the CABI report, CABI Senior Research Advisor, and Olin Adjunct Lecturer, said:
“Our results were pretty amazing: 50% of the available capacity is underutilized,” he said. “The numbers were astonishing.”
The Biden administration said on Sept. 14 that it would invest another $2 billion in biotech and biomanufacturing efforts.
Over 30 billion doses possible
Last year, the generic drug industry made headlines when it announced the closure of several US manufacturing plants. Factors include reduced offshore operating and labor costs, intense price pressures, and a steadily increasing reliance on offshore sources of raw materials.
“How do you explain this discrepancy?” Sardera asked. He and his team surveyed 37 generic drug manufacturing facilities in the United States. They found that the site was producing only half of its annual capacity, with a total overcapacity of almost 50%. In fact, of his 37 manufacturing sites, only two are in full production.
Once operational, the site will allow approximately 30 billion additional doses of essential and critical drugs to be manufactured in the United States without the cost and effort of building a new manufacturing plant, allowing generics to be replaced from domestic sources. The report found that the time it takes for medicines to become available could be shortened. .
In a nutshell, the report recommends:
- Repurpose idle sites to address manufacturing shortages, increase supply chain resilience, and enable supply to build within 24-36 months.
- Continue current federal funding efforts for advanced manufacturing technologies to reduce production costs, create new workforce opportunities, and increase the economic sustainability of U.S. drug manufacturing.
Research aims to nurture national policy
Sardera, whose research has focused on issues at the intersection of business, government, and society, will present the results of his paper at the National Press Club in Washington on Tuesday, October 4, to promote the sustainability of U.S. drug manufacturing. Support policy considerations and initiatives to strengthen. .
CABI’s next step is a new paper in progress on how to model funding initiatives that reduce the risk of employing advanced manufacturing technologies such as continuous-flow chemistry to drive production.