What Policy Tools Move the Needle on API Manufacturing Capacity?

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, discusses how federal policy is shaping efforts to reshore active pharmaceutical ingredient (API) manufacturing and strengthen domestic capacity. He characterizes the policy environment as notably bipartisan, with agreement across both political parties and the last administrations on several core principles: the United States needs better visibility into critical medicines, more secure domestic capacity for those products, and fewer single points of failure in supply chains.

McHam points to specific legislative efforts as evidence of this alignment. He cites the Clear Labels Act and the Maps Act, noting sponsorship from both Republican and Democratic senators, including Senator Scott, Senator Gillibrand, and Senator Gary Peters. On the House side, he references Representative Wesley Bell’s work to include NDA-related language in committee processes, guiding how the defense sector should factor U.S.-made pharmaceuticals into purchasing decisions. These initiatives collectively aim to strengthen transparency, resilience, and prioritization of domestic production in federal procurement.

Beyond legislation, McHam emphasizes the importance of sustained federal investment. He notes that both the first Trump administration and the Biden administration, as well as the subsequent Trump administration, have used industrial base management, supply chain authorities, and Defense Production Act tools to bolster a strategic stockpile and an API reserve.

In his view, such investments help build foundational capacity but are not sufficient on their own.