The Journal reports this morning that:
The U.S. Food and Drug Administration banned imports of more than 30 generic drugs made by India’s Ranbaxy Laboratories Ltd., citing concerns about the safety of the company’s production practices.
The ban affects low-cost versions of popular medicines such as the anticholesterol drug Zocor; Acyclovir, which treats herpes; the heartburn pill Zantac; and AIDS drugs. Consumers shouldn’t be affected by a medicine shortage because the drugs can be supplied by other generics makers, the agency said.
The agency said it acted because of concerns about the “seriousness and extent” of violations of manufacturing standards at two Ranbaxy plants in India. The agency said it hasn’t found safety problems in drugs in the U.S.
There are a number of aspects of this story that are scary. First, I’m involved peripherally in the issues surrounding offshoring personal data to countries like India. The complexities of that should be reserved for another post, but a basic problem involves supervision and accountability. How can you tell that data has been misused or stolen? The complexities must be more severe in ensuring that drug makers have sound practices. I would imagine that US regulators cannot detect most violations of the rules.
Second, for our government to take action against a drug maker means that things were really screwed up. And if things were really screwed up, why should we believe that Ranbaxy-made drugs in the US are unaffected?
More broadly, is there any way for consumers to ensure that their generic or branded drugs are made in the US? I read every day about the Chinese Poison Train (next stop, you), and would like to limit my exposure to leaded or otherwise tainted foreign products.
Here is the FDA’s release on the Ranbaxy action, and the list of affected drugs.