Today, in Acetris Health, LLC v. United States, the Federal Circuit held that a pharmaceutical manufactured in the United States qualified for sale, under the Trade Agreements Act of 1979 (TAA), to the Department of Veterans Affairs even though the active pharmaceutical ingredient (API) came from a non-designated country, India. In reaching this decision, the court questioned, without deciding, the longstanding Customs and Border Enforcement position that the country where the API was manufactured…

On April 30, 2019, the Department of Justice (DOJ) Criminal Division issued an updated version of the “Evaluation of Corporate Compliance Programs” guidance originally published by the Criminal Division’s Fraud Section in February 2017. The update is more of a consolidation of various compliance program evaluation sources under the broader Criminal Division umbrella than a sweeping change in policy or philosophy, but there are some practical takeaways. In announcing the release, Assistant…

  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…

On Valentine’s Day, two subcommittees of the House Committee on Science, Space, and Technology held a joint hearing on the potential application of blockchain technology beyond cryptocurrency and financial technology. This hearing highlights the U.S. Government’s growing interest in blockchain, a Distributed Ledger Technology (DLT) that has powered platforms for secure and decentralized transactions. While its most visible exponent, Bitcoin, has been a hot topic, blockchain is gaining traction among some federal agencies as a…