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.”

For more information on the implications of the Acetris decision for federal procurement opportunities, please contact Jon Williams at (202) 857-1000 or jwilliams@pilieromazza.com.

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