The U.S. must treat its prescription drug supply as a national security issue and bolster supply chain resilience through targeted investment, coordination and quality improvements, according to a Nov. 10 report stemming from a workshop hosted at Baltimore-based Johns Hopkins University. Martin Makary, MD, commissioner of food and drugs at the FDA, joined government, academic and industry leaders to propose four strategies to improve resilience.
1. Enable domestic manufacturing.
A 2022 survey found that one-third of U.S. generic drug sites were operating a half or less of their production capacity. Experts said the federal government must provide stronger demand signals and reimbursement incentives to sustain domestic manufacturing over time.
2. Prioritize quality over price.
Panelists called for a shift away from lowest-bid contracts that favor cheaper generics. With FDA inspections still below pre-pandemic levels, speakers said rewarding high-quality manufacturers is key to reducing dependency and improving reliability.
3. Refine global supply partnerships.
Rather than cutting off foreign supplies, experts said the U.S. should pursue “ally-shoring” with trusted trade partners and use quality as a filter. About 700 medications rely on at least one ingredient sourced solely from China.
4. Appoint a lead agency.
Currently, no federal agency is responsible for managing drug supply chain resilience. Leaders recommended giving the FDA new authorities to collect and share data, and designating an agency to coordinate action before shortages occur.
