Ranbaxy Is Disappointed, But Is It Surprised?

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huhIn an unusual move, the FDA yesterday issued an import alert for 30 generic meds made by the Indian drugmaker, which means federal authorities have the right to stop the drugs from entering the US. The agency also issued warning letters to Ranbaxy for failing to meet acceptable manufacturing standards at two plants in India. This resulted from an investigation that began three years ago.

Today, Ranbaxy issued this statement: “Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made.”

Ranbaxy execs, though, seem to have a peculiar definition of ‘progress.’ You may recall federal prosecutors are investigating the drugmaker for allegedly falsifying records that resulted in the production and sale of generic meds that didn’t meet FDA standards, including AIDS drugs that are distributed as part of the PEPFAR program (although a key Bush administration official seemed oblivious at the time).

The feds alleged officials at Ranbaxy’s plant in northern India used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors. The Parexel consulting firm is also named in connection with its audits of Ranbaxy facilities, some of which Ranbaxy refused for months to produce, claiming attorney-client privilege.

The FDA may have been slow to act, as the House Energy & Commerce Committee alleges, but the agency found problems as recently as last March, when an inspection took place, and wasn’t satisifed with Ranbaxy responses this past May. Meanwhile, this is the same drugmaker that, as recently as July, was stonewalling the US Attorney in Maryland over submitting audits. One has to wonder - what did Ranbaxy execs expect?

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