In October 2019, Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, testified before Congress that the United States “has become a world leader in drug discovery and development, but is no longer in the forefront of drug manufacturing.” 72% of API manufacturing takes place outside the U.S., and the use of foreign-sourced materials “creates vulnerabilities in the U.S. supply chain,” Woodcock concluded.
