The Office of Management and Budget (“OMB”), Made in America Office issued a Final Rule to clarify the Build America, Buy America Act (“BABA”) provisions of the Infrastructure Investment and Jobs Act4 (“IIJA”) and to clarify...more
On July 21, 2023, President Biden designated July 23-29, 2023, as “Made in America Week.” This proclamation builds on the Biden Administration’s efforts to bolster domestic manufacturing through evolving policies attached to...more
Despite their many differences, Presidents Trump and Biden agree on one thing: that the Government should favor American manufacturers over foreign companies by tightening the protectionist restrictions applicable to many...more
On January 25, 2021, President Biden issued an Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers. The order is part of his “Build Back Better Recovery Plan” to strengthen American...more
On January 25, 2021, President Biden issued a sweeping Executive Order titled “Ensuring the Future Is Made in All of America by All of America’s Workers” (Order), which is intended to be the first step toward fulfilling his...more
Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more
On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more
A recent Federal Circuit court decision promises to significantly impact and broaden the scope of the types of foreign-produced pharmaceutical products companies can sell to the U.S. government. ...more
A variety of arcane domestic-preference regimes apply to many Federal procurements – the Buy American Act (BAA), the Trade Agreements Act (TAA), the Berry Amendment, and the Cargo Preference Act, to name a few. In Acetris...more
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...more
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active...more
Trade Agreements Act compliance changed fundamentally three years ago. Or, so we thought on December 7, 2016, when the U.S. Court of International Trade (“CIT”), the appellate body for country of origin determinations issued...more
On July 15, 2019, President Trump issued an executive order directing the Federal Acquisition Regulatory Council (the “Council”) to amend the Federal Acquisition Regulations (“FAR”) to change the definition of foreign goods...more
• The White House has issued a new Executive Order designed to promote the use of American-made products in all infrastructure projects receiving federal funding, another step in the Trump Administration's Buy American...more
A recent ruling by the U.S. Court of International Trade (CIT) has important implications for importers and manufacturers making “Made in USA” claims for products assembled from imported components. While the case concerned...more
Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more
Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more
On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more
The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more
A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more