Supply Chain Securities

In June 2021, the Biden–Harris administration announced a task force to address “short term supply chain discontinuities” (1). This included strengthening Executive Order 13944, a list of essential medicines, medical countermeasures, and critical inputs (2). A report published in May 2022 highlights fundamental pillars one would expect (3).

A proposed bill by US Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, building off several reports he released in the past few years, proposes to assess national security vulnerabilities in the pharmaceutical supply chain by the Mapping America’s Pharmaceutical Supply (MAPS) Act. This database will include key information about critical drugs such as the country of origin and quantity so supply chain weaknesses can be identified (4). While this might seem duplicative of other database systems such as North American Industry Classification System codes, it can be seen as part of a macro trend for government, to take further action in an already highly regulated industry. The Inflation Reduction Act (IRA) and the National Biotechnology and Biomanufacturing Initiative are cut from the same cloth.

Rumors have swirled about an under-the-radar White House initiative to gather pharmaceutical supply feedback to present potentially radical options. On this initiative, but specifically commenting on generics, Elisabeth Reynolds, a Massachusetts Institute of Technology lecturer and former special assistant to Biden for manufacturing and economic development at the National Economic Council, said, “There’s a lot of resistance in the industry to more transparency or anything that requires more cost in this low-margin business. We have to find ways to provide incentives to invest in quality, or put in place requirements to make them responsible for quality” (5).

Tom Kraus, VP government relations for the American society of health-system pharmacists, strongly supports MAPS, saying, “By requiring HHS to coordinate with other agencies and the private sector to map the pharmaceutical supply chain, threats to the US pharmaceutical supply chain can be identified and addressed before they place patients at risk” (5).

References

1. White House. FACT SHEET: Biden-Harris Administration Announces Supply Chain Disruptions Task Force to Address Short-Term Supply Chain Discontinuities. Whitehouse.gov. June 8, 2021.

2. FDA. Reports, Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs. August 2020.

3. The Advanced Regenerative Manufacturing Institute (ARMI). Essential Medicines Supply Chain and Manufacturing Resilience Assessment. BioFabUSA Roadmap Reports, Special Reports.

4. Senator Gary Peters Office, Peters Introduces Bipartisan Bill to Assess National Security Vulnerabilities in the Pharmaceutical Supply Chain. Press Release. July 20, 2023.

5. Griffin, R.; Edney, A.; Swetlitz, I. Secret White House Team Tackles Drug Shortages, Quality Woes. Bloomberg News. May 2023.

About the author

Mike Hennessy Jr. is the President and CEO of MJH Life Sciences.

Article details

Pharmaceutical Technology
Vol. 47, No. 8
August 2023
Page: 8

Citation

When referring to this article, please cite it as Hennessy, M.
Supply Chain Securities. Pharmaceutical Technology 2023 47 (8).