Apotex Sues FDA Over Import Alert That ‘Decimated’ Its Business

Apotex Sues FDA Over Import Alert That ‘Decimated’ Its Business

March 16th, 2012 // 12:51 pm @ jmpickett

Source: Pharmalot

Three years ago, the FDA issued an import alert for all meds made at a pair of Canadian facilities run by Apotex, which was one of the biggest generic suppliers to the US market, which subsequently recalled 675 batches of different drugs. The move came after the FDA sent warning letters to the drugmaker about severe manufacturing problems. Shipments were allowed to resume last summer.

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Now, though, Apotex claims the import alert “decimated” its business, since the plants produced about 80 percent of the meds sent to the US, and the US market accounted for 60 percent of companywide revenue, and is seeking hundreds of millions of dollars in damages, according to a filing with the International Centre for Settlement of Investment Disputes. At the same time, the drugmaker charges that rivals with comparable problems were shown more favored treatment.

In arguing its case, the drugmaker charges the FDA was out of step with other government agencies, notably Health Canada, which Apotex maintains found its two plants needed improvement but, nonetheless, remained compliant with good manufacturing practices. But convincing the FDA to review the situation proved challenging, according to the complaint.

Despite repeated efforts, Apotex claims the FDA “inexcusably” delayed follow-up inspections that, ultimately, showed compliance was achieved, but as a result, the drugmaker operated under those circumstances longer than needed. Consequently, Apotex also claims the FDA delayed lifting the import alert and approval for pending applications for marketing drug, leading to more than $520 million in damages.

“Due to the import alert and FDA’s course of action, Apotex was prevented from selling billions of dosages of products on the US market from August 28, 2009 to July 29, 2011,” the complaint states. “During this period, Apotex also missed the window of opportunity to launch the first generic versions of several patented products on the American market. Thus, Apotex lost sales, market share and momentum… the ability to realize substantial returns on its investments.”

Meanwhile, Apotex charges the FDA took a different approach to Teva Pharmaceuticals, which was also found to have difficulties complying with good manufacturing practices that were detailed in 483 inspection reports. However, Teva was not issued an import alert or prevented from selling its medicines in the US. And by allegedly showing favoritism, the FDA violated the North American Free Trade Agreement (here is the complaint).