The FDA has again issued an import alert against a plant owned by Canadian generic drugmaker Apotex, this one in India. The last time the agency took that kind of action, Apotex took the matter to international authorities in a North American Free Trade Agreement (NAFTA) complaint.
According to an FDA posting, on Tuesday the agency banned products from an Apotex plant in Bangalore. The alert, however, says that Apotex's riluzole tablets, a drug used to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease, were excluded from the detention without physical examination action. The action follows the bans of other India plants in the last year, including two from Ranbaxy Laboratories, two from Wockhardt and one from Sun Pharmaceuticals. The company said in an emailed statement that it was working closely with the FDA to resolve the problems.
Apotex had products from plants in Toronto and Quebec banned from 2009 to 2011, after FDA inspectors found a number of problems. Warning letters issued in 2009 and 2010 discussed contaminated drug ingredients, the return of defective material to inventory and the rerelease of failed material prior to sufficient reprocessing and testing. Those problems led Apotex to recall 675 lots of products.
The ban was lifted in 2011, but the FDA cited the same plants last year with a new warning letter. This time observations included problems with air flow that could lead to contamination and the release of partial batches of products after some had failed testing. It also mentioned a lack of space and "personnel resource constraints" that resulted in vials of sterile drugs sitting for a week before going into incubation.
Once the ban was lifted, Apotex complained to NAFTA that the FDA action "decimated" its business and cost it $520 million in lost sales. It argued that the ban violated NAFTA, claiming the FDA treated Apotex less fairly than other companies, like Teva Pharmaceutical ($TEVA). Apotex is asking the treaty oversight agency for arbitration in an effort to get the U.S. to reimburse it.
- find the import alert here