On August 23, 2023, the White House’s Office of Management and Budget (“OMB”) issued its notification of final guidance implementing Title IX of the Infrastructure Investment and Jobs Act (“IIJA”) – the Build America, Buy...more
Recently the Federal Trade Commission entered into a settlement under which Patriot LED must pay civil damages of nearly $158,000, plus a penalty of $2.96 million, for its alleged false marketing of lighting products as...more
What is a thing? On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit gave us a new answer to this old philosophical question. In the case of pharmaceuticals, the U.S. Department of Veterans Affairs (VA)...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
In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more
The Court found the disqualification of an offeror from a pharmaceutical procurement was in error based on a U.S. Customs and Boarder Protection (CBP) interpretation of the Trade Agreements Act of 1979 (TAA)....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
Few phrases sum up the Trump administration’s policy goals better than “Buy American.” We hear it in advertising; we hear it in the State of the Union; and we find it littered throughout government buying priorities. Here is...more
The Trade Agreement Act (“TAA”) utilizes a “substantial transformation” test in determining the country of origin of an end product composed of various parts from various countries. Substantial transformation is assessed and...more
On May 5, 2016—without advance warning—thousands of U.S. General Services Administration (GSA) Multiple Award Schedule (MAS) contract holders received a notice requiring them to verify—within one week—the country of origin...more
Government Contractors should be aware that the General Services Administration ("GSA") is taking a more aggressive approach to policing Contractor compliance with the Trade Agreements Act ("TAA") among GSA Schedule contract...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
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
One of the most perplexing questions that has plagued the government contracting community in recent years relates to the country of origin for computer software. Where most government procurements restrict the purchase of...more