On July 16, 2018, the Court of Federal Claims released a far-reaching decision in Acetris Health, LLC v. United States, concluding that a drug could qualify as a “U.S.-made end product” under the Trade Agreements clause, FAR 52.225-5, despite a Customs and Border Protection (CBP) ruling under the Trade Agreements Act (TAA), that the drug had not been “substantially transformed” in the United States, the usual test for whether a product from a designated country is eligible for sale to the United States under the TAA. The court concluded that a drug which met the definition of a “domestic end product” would also qualify as a “U.S.-made end product” and enjoined the Department of Veterans Affairs from relying on the CPB ruling in declaring the product ineligible. In doing so, the court has given effect to often overlooked language in the FAR 25.003 definition of “U.S.-made end product” that allows either an item manufactured in the United States or an item substantially transformed in the United States to be eligible for sale to the federal government. The decision opens the door for manufactured COTS items to be eligible under the TAA as long as final assembly occurs in the United States, without regard to the source of a COTS product’s components. It might even have broader implications because the FAR has never included an express definition of “manufacture,” and the definition of “U.S. made end product” does not expressly reference the definition of “domestic end product,” under which, in the Buy American context, “manufacture” is just one of two elements for determining eligibility.

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Photo of Alan W. H. Gourley Alan W. H. Gourley

Alan W. H. Gourley is a partner in the Washington, D.C. office of the law firm of Crowell & Moring and serves as a member of the Steering Committee for the firm’s Government Contracts Group. He graduated magna cum laude from Beloit College…

Alan W. H. Gourley is a partner in the Washington, D.C. office of the law firm of Crowell & Moring and serves as a member of the Steering Committee for the firm’s Government Contracts Group. He graduated magna cum laude from Beloit College in 1977 and from the University of Virginia School of Law in 1981. He is a member of the District of Columbia bar.

Photo of Lorraine M. Campos Lorraine M. Campos

Lorraine M. Campos is a partner and member of the Steering Committee of Crowell & Moring’s Government Contracts Group and focuses her practice on assisting clients with a variety of issues related to government contracts, government ethics, campaign finance, and lobbying laws. Lorraine…

Lorraine M. Campos is a partner and member of the Steering Committee of Crowell & Moring’s Government Contracts Group and focuses her practice on assisting clients with a variety of issues related to government contracts, government ethics, campaign finance, and lobbying laws. Lorraine regularly counsels clients on all aspects of the General Services Administration (GSA) and the U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) programs. She also routinely advises clients on the terms and conditions of these agreements, including the Price Reduction Clause, small business subcontracting requirements, and country of origin restrictions mandated under U.S. trade agreements, such as the Trade Agreements Act and the Buy American Act. Additionally, Lorraine advises life sciences companies, in particular, pharmaceutical and medical device companies, on federal procurement and federal pricing statutes, including the Veterans Health Care Act of 1992.

Lorraine has been ranked by Chambers USA since 2013, and she was recognized by Profiles in Diversity Journal as one of their “Women Worth Watching” for 2015. Additionally, Lorraine is active in the American Bar Association’s Section of Public Contract Law and serves as co-chair of the Health Care Contracting Committee.