The Federal Circuit struck down an element of the government’s longstanding definition of what qualifies as U.S.-made for purposes of procurement law. In Acetris Health LLC v. United States, No. 18-2399 (Fed. Cir. 2020), a three judge panel found the Department of Veterans Affairs’ (VA) definition of U.S.-made to be “untenable” and instead found that pharmaceuticals with an active ingredient from India that are manufactured into final form in the U.S. qualify as U.S.-made for purposes of procurement law. The decision, if not successfully challenged, will have broad-ranging impacts not only in the pharmaceutical industry but for many government contractors with international supply chains. It also raises important questions about how federal agencies will implement the court’s guidance.
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