Apotex Sues U.S. Government, Says Import Ban ‘Decimated’ Business

April 6, 2012

Canadian generic giant Apotex is suing the U.S. government, saying the FDA’s 2009 import ban on two of its Ontario plants “decimated” its U.S. business and violated the North American Free Trade Agreement (NAFTA). The drugmaker seeks $520 million in damages.

The suit, filed in the World Bank Group’s International Centre for Settlement of Investment Disputes, also claims the FDA treated U.S. companies in like circumstances more favorably during the two-year ban on imports from the Etobicoke and Toronto, Ontario, facilities.

Between Aug. 28, 2009, when the agency first placed an import alert on the plants, and its subsequent lifting in late July 2011, “no such investor or investment was subjected to a measure as severe as the import alert imposed on the Apotex companies,” the drugmaker said in the suit.

To avoid a monetary hit like Apotax, make sure you keep your company up to snuff. One example of something to watch is the FDA’s implementation of its new computerized import-screening tool, PREDICT. How will this affect the entry of products into the U.S.? With FDAnews’ FDA Import Holds: How to Win Releases and Fight Holds and Refusals, you’ll have the answer.

This management report is designed to address your specific concerns about PREDICT and the new FDA import processes — and show you how to prepare to successfully get your imported products through customs as quickly as possible.

Don’t wait until import regulations are dished onto your already-full plate, order this report today and be ready for the FDA.