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3/20/2013 7:45:54 AM
In the latest row between the FDA and Apotex over its manufacturing practices, the agency has issued another warning letter that takes the generic drugmaker to task for a host of serious violations at two separate plants in Canada. The missive also notes that agency inspectors encountered repeat infractions and a persistent failure to make the necessary corrections. There is a sad history here. Four years ago, the FDA issued an import alert for all drugs made at two Canadian plants. Until then, Apotex was one of the biggest generic suppliers to the US market, but subsequently recalled 675 batches of different drugs. Shipments were allowed to resume in 2011 (back story), but last May, Apotex turned around and filed a claim seeking hundreds of millions of damages because the import alert ‘decimated’ its business. In arguing its case, Apotex maintained the plants affected by the import alert produced about 80 percent of the drugs shipped to the US, and the US market accounted for 60 percent of companywide revenue (back story). But the FDA was clearly not going to wait for the case, which was filed before the International Centre for Settlement of Investment Disputes (see this), to be resolved before conducting a new round of inspections.
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