“I’m sure there are many manufacturers who have just seen their products become TAA-compliant overnight . . .,” said Jon Williams, commenting on the U.S. Court of Appeals for the Federal Circuit’s February 10th ruling in Acetris Health, LLC v. United States.
The court held that a U.S.-manufactured drug from Acetris was compliant with the Trade Agreements Act (TAA), despite Acetris sourcing an active pharmaceutical ingredient for the drug from a non-designated country under the TAA. This indicates that pharmaceutical companies should worry less about TAA compliance when sourcing active pharmaceutical ingredients from non-designated countries.
Daniel Seiden of Bloomberg Law recently featured Jon’s comment in an article on the ruling, “‘Buy American’ Drug Decision Opens Door to Foreign Supplies.”