Researchers at the Johns Hopkins Bloomberg School of Public Health have published a report assessing the COVID-19 pandemic's impact on the U.S. pharmaceutical supply chain, including recommendations on how to address drug shortages as well as production and distribution issues.
In the report, the investigators say that the demands of the public health crisis have revealed vulnerabilities in the U.S. drug supply chain, from delayed regulatory oversight of drug production to limited understanding of local and demand-driven shortages to inadequate planning and management.
The researchers' recommendations for mitigating these problems are as follows:
- The FDA should timely disclose and mitigate demand-driven and local-level shortages.
- To strengthen pharmaceutical production, Congress should authorize the FDA to create and publish quality metrics for the manufacturing process.
- To strengthen the global supply chain, the FDA should establish a database of approved manufacturers of active pharmaceutical ingredients.
- To expand production capacity, the FDA should expand the current mutual recognition agreement between the U.S. and Europe.
- Congress should further incentivize domestic production of essential pharmaceuticals.
- The federal government should stand up a comprehensive effort to assess and manage the U.S. pharmaceutical supply chain.
- When necessary to mitigate shortages, the Department of Health and Human Services should allow additional manufacturers to produce patented medications.