The COVID-19 pandemic has served as a wake-up call—revealing weaknesses in global and U.S. medicine manufacturing and distribution.
Critical medicine shortages have been exacerbated and new ones have been triggered.
According to testimony presented by RAND, the quantities of material in the stockpile were not nearly enough to fill all the requests, resulting in a heated supply competition, and an inability to deliver products across the United States equitably.
The weaknesses revealed by the COVID-19 pandemic also present opportunities to advance pharmaceutical manufacturing into the 21st century.
The security of the nation’s drug supply rests on three main factors: freedom from dependence on foreign sources of API, the resilience of our domestic manufacturing base, and the reliability of the facilities that make products for the U.S. market.
Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA in testimony given before the House Committee on Energy and Commerce, Oct. 19, 2019
To achieve the goal of medicine self-sufficiency, it is essential that the U.S. establish a critical manufacturing infrastructure that is end-to-end, automated and has the flexibility to be distributed.
|U.S. Pharmaceutical Manufacturing Needs||ODP Capabilities|
|Advanced Quality Management Systems||fa-check|
|Ability to respond quickly to surges and crises||fa-check|
|Resilient distributed manufacturing model||fa-check|