
How Do You Bridge the Gap Between Industry and Federal Policy?
Key Takeaways
- A persistent policy–industry disconnect stems from resilience-driven objectives colliding with generic manufacturers’ thin margins and limited tolerance for capital risk.
- Demand certainty is a prerequisite for reshoring decisions, because capacity investments require predictable utilization and revenue over long time horizons.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center,argues that closing the gap between federal reshoring policy and manufacturer investment requires more than incentives.
Gerren McHam, vice president of Government and External Affairs, API Innovation Center, explains how the organization works at the intersection of industry and federal policy to bridge differing views on what realistic reshoring looks like. McHam identifies the central friction point as the economic reality faced by the generic pharmaceutical industry, which often operates with low returns on investment. In this context, manufacturers require strong certainty of demand before committing capital to new or expanded domestic facilities.
McHam notes that federal investment in domestic manufacturing, while important, does not automatically guarantee that manufacturers will see reshoring as a sound business decision. Companies still need confidence that the market will generate sufficient pull-through on the back end to make those investments worthwhile. This is a recurring barrier in discussions between policymakers who emphasize resilience and manufacturers who must weigh margins and long-term viability.
To address these challenges, McHam describes the API Innovation Center’s focus on advanced manufacturing technologies and process innovations that lower production costs. By applying continuous flow technology, the center has been able to reduce routes of synthesis from as many as five steps to two. This streamlining decreases the amount of solvent and key starting material required, with the aim of driving efficiencies throughout the production cycle and making U.S.-based manufacturing more cost-competitive.
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