Merle M. DeLancey, Jr. and Shane M. Hannon ●


On July 28, 2026, the U.S. Court of Federal Claims issued its decision in AvKare, LLC v. United States[1], upholding the Department of Veterans Affairs’ (“VA”) national contract award for Hydroxychloroquine tablets. The opinion is an important reminder of the discretion contracting officers have to evaluate pharmaceuticals for Trade Agreements Act (“TAA”) compliance and reaffirms that the country where a drug’s active pharmaceutical ingredient (“API”) is synthesized can be its country of origin for TAA purposes. The Court also declined to extend the scope of the Federal Circuit’s 2020 Acetris decision which would have conflated “manufacturing” and “substantial transformation.”
Overview of the TAA
The TAA provides that the Government may only acquire “U.S.-made or designated country end products.” See FAR 52.225-5. The TAA states that if a product comprises materials from multiple countries, its country of origin is where it was “substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.” 19 U.S.C. § 2518(4)(B). If a product is “substantially transformed” in a TAA-designated country, the product complies with the TAA.
Continue reading “Court of Federal Claims Reaffirms Agency Discretion in TAA Country-of-Origin Determinations for Pharmaceuticals”







Almost daily, clients call our office seeking to protest the award of a federal government contract. Unfortunately, sometimes these calls are too late. While contracts can be protested at the agency level, the Court of Federal Claims, and the Government Accountability Office (“GAO”), GAO protests are the most common. The deadlines by which a protester must take certain actions to file a timely protest are confusing. Below we address some of the trickier and/or mandatory deadlines a potential protester must meet to file a timely protest, and we provide a useful sample timeline for protesters to follow during this critical process.