APM Tech Hub Policy Support Needed

In addition to financial investments, we recognize that policy efforts are needed to advance broader geographic diversification of the manufacturing base including incentives to advance more U.S.-based medicine production.

Under the leadership and guidance of the Policy Team at USP, we recognize the critical need to foster more resilience in the manufacturing base for U.S. drug products—especially for medicines or ingredients that are most vulnerable to supply disruptions—and to reduce the risk to patients of potential disruptions and shortages that result from the concentration of drug manufacturing in limited geographies and reliance on manufacturing in old facilities in regions where FDA oversight is limited or inconsistent.

The APM Consortia supports:

• Economic or other incentive measures that will encourage multiple suppliers for key drugs, geographic diversification of manufacturing facilities, and broader component supply.
  • Economic incentives to encourage increased domestic manufacturing of APIs and finished drug products in the United States, prioritizing specific medicines or ingredients that are most vulnerable to supply disruptions.
  • This should include targeted investment in the development of drugs that are at high risk of shortage to ensure reserve U.S. manufacturing capacity for essential medicines that cannot be manufactured competitively at current market prices.
• Market-based and pricing incentives that support domestic pharmaceutical manufacturing capacity.
• Financial incentives to provide manufacturers with the necessary support to build facilities supporting advanced manufacturing technologies (AMTs) that make U.S. production more cost-competitive.
• The development of tools and standards to help reduce the technical barriers to wider adoption of AMTs and support medicine quality.
• The creation and/or support of public-private partnerships to bridge knowledge gaps, help understand the needs of manufacturers, identify best practices, and leverage the experience of those with extensive knowledge of AMT.