MATT HICKS, PATRICK STEVENS
Federal Equipment Company, Cleveland, USA

Abstract

Drug and active pharmaceutical ingredient (API) supply chains have raised concerns in the United States, including drug pricing, drug shortages, national security, and critical drug supply. Despite those concerns, few steps were actually taken to address these issues. The global pandemic intensified scrutiny of U.S. pharmaceutical supply chains. This article will summarize and analyze recent U.S. legislative and executive actions and a report with policy recommendations regarding API and drug supply chains intended to address those concerns for future API and drug manufacturing.

Active pharmaceutical ingredient (API) manufacturing in the United States has seen years of outsourcing and offshoring strategies aimed at reducing costs. Today, many drugs considered “critical” have complex global supply chains that are known only by their manufacturers. Concerns over drug and API supply chains were raised well before COVID19 (1), but relatively few changes resulted until the global pandemic brought pharmaceutical supply chain issues to the forefront. Now the U.S. Government acknowledges the need to ensure a cost-effective, secure supply of essential drugs with legislative, regulatory, and executive measures which will impact the U.S. market for API and finished drugs.

THE CARES ACT
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (2) amended the Federal Food, Drug and Cosmetic Act (FD&C) to help the U.S. Food and Drug Administration (FDA) “identify, prevent, and mitigate possible drug shortages by...enhancing FDA’s visibility into drug supply chains (3).” These amendments expanded the definition of “critical drugs” to include those determined critical in a public health emergency a ...