NAFTA says FDA was in its rights to ban Apotex plants

Apotex's Etobicoke facility--Courtesy of Apotex

It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.

"The FDA's import alert against our Etobicoke and Signet facilities effectively removed Apotex from the U.S. solid-dose drug market for almost two years," Jeremy Desai, the newly apponted CEO of Apotex, said in a statement Wednesday. "While we are disappointed in the Tribunal's decision, we remain strongly committed to the U.S. market and we continue to work closely with the FDA to resolve all outstanding issues and to achieve our shared objective of expanding the public's access to quality, affordable generic medicines."

Shortly after the bans were lifted in 2011, Apotex made its charges to NAFTA saying that the bans had "decimated" its U.S. business, costing it $520 million in lost sales. The agency had banned the plants after several years of back and forth with the company over issues inspectors had found. But Apotex told NAFTA it believed it had been treated differently than some other drugmakers, like Teva Pharmaceutical ($TEVA), which had some plant issues with the FDA at about the same time, but was not prevented from selling products in the U.S. and which the FDA resolved with the company quickly.

The FDA lifted the bans against Apotex in 2011, but has continued to find issues with the Canadian generics maker. Two years later, it issued new warning letters for the plants. Then in April of this year, it issued another import alert against the company, this time for a plant in Bangalore, India. The action on the Bangalore facility includes everything except its riluzole tablets, a drug used to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease. The company has said it is working closely with the FDA to resolve the problems.

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