“Those who cannot remember the past are condemned to repeat it.” - George Santayana. As an example of this I present to you the Smoot-Hawley Tariff Act of 1930. If you are not familiar with this, it is worth taking a moment...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
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 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
ANTICORRUPTION DEVELOPMENTS - $34 Million SEC Settlement for Legg Mason - On August 27, 2018, the Securities and Exchange Commission (SEC) announced that Legg Mason Inc. will pay more than $34 million to settle an...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