Key Considerations for Reshoring U.S. Drug Manufacturing

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This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The episode features Members of the Firm Delia Deschaine and Neil Di Spirito and is hosted by attorney Bonnie Scott.

Here’s a preview of what you’ll hear:

“The risk of FDA enforcement action that significantly disrupts the supply chain is, in fact, greater for companies that rely on foreign versus domestic entities.” —Delia Deschaine, Member of the Firm
“Development and integration of technology, like continuous manufacturing and 3D printing, would be necessary to effectively make reshoring feasible.” —Neil Di Spirito, Member of the Firm
“There's also this need for balance, likely some sort of hybrid model, where U.S. production may be ramped up to help bolster supply, but we would still lean on foreign manufacturers for many of the same reasons offshoring has been so appealing to date.” —Bonnie Scott, Associate

About the Diagnosing Health Care Podcast

What health care and life sciences decision-makers need to lead, comply, and compete. The health care industry is full of high-stakes legal, policy, and regulatory obstacles. And significant opportunities for those prepared to act on them. Diagnosing Health Care® delivers the intelligence executives, general counsel, and administrators need to navigate both. Part of the Epstein Becker Green Insights Network.