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API Innovation Center tells Missouri committee it can help reshore generic drug production
Summary
The API Innovation Center presented data to the Missouri Emerging Issues Committee arguing that the U.S. relies heavily on foreign sources for generic active pharmaceutical ingredients and that existing U.S. manufacturing capacity can be activated with targeted investment, contracts and partnerships.
Tony Sardela, president and CEO of the API Innovation Center, told the Missouri Emerging Issues Committee that the organization’s work focuses on the data and business models needed to bring active pharmaceutical ingredient (API) manufacturing back to the United States.
Sardela said the API is “the component in a medicine that makes it effective for treatment,” and presented three findings from the center’s research: more than 91% of prescriptions in the U.S. are for generics; 83% of the top 100 prescribed medicines have no U.S. source for their active ingredient; and about one-quarter of foreign production for those medicines is from facilities with U.S. Food and Drug Administration violations or warning letters.
The presentation said that the nation’s vulnerability is not primarily logistical but economic: U.S. firms face predatory pricing and other market pressures that have driven production offshore even as FDA‑approved manufacturing capacity in the United States sits unused. Sardela told the committee that interviews with U.S. manufacturers indicate more than half of approved manufacturing capacity is idle and that, collectively, those facilities could produce an estimated 30,000,000,000 doses of medicine per year if fully activated.
Sardela described the API Innovation Center’s approach — “invest, contract and partner” — as a model to mobilize existing U.S. capacity by providing investment to adopt new technologies, securing contracts with end customers, and partnering across health systems and retailers to guarantee demand. He said state support through the Missouri Technology Corporation and the Department of Economic Development helped the center bring production of lomustine, a brain‑cancer drug in shortage, to a small business in St. Louis and win federal interest and funding under a Defense Production Act Title 3 program through a BioMap consortium award.
Sardela said the center aims to commercialize 25 medicines within five years and ultimately scale to about 300 medicines, estimating $1.2 billion in regional economic stimulus from the first 25 and larger gains if scaled. The presentation was informational; Sardela and other presenters were invited to follow up by email on complex topics.
Committee chairmen and members asked no substantive follow‑up questions during the allotted time. The hearing was organized as an informational session and did not include any committee motions or votes on policy.
The presentation and committee discussion made clear the center’s emphasis is on contracting and coordinating dormant U.S. manufacturing capacity rather than building new factories.
