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FDA issues warnings on Indian-made generic prescription drugs

September 16, 2008 |  5:37 pm

The U.S. Food and Drug Administration on Tuesday put the Indian generic drug giant Ranbaxy on notice that it would block entry to the U.S. market of 25 generic prescription drugs widely used by American consumers. The FDA "warning letter" faulted Ranbaxy, the world's largest manufacturer of generic pharmaceuticals, for observing inadequate quality controls and manufacturing standards in the production of generic versions of drugs used to treat diabetes, high cholesterol, epilepsy and infections, among other conditions.

See the FDA's warnings, and its Q&As for consumers, here.

The FDA says it has found no evidence that consumers have been harmed by shoddy production standards that were observed in manufacturing these generics at two plants in India. It's not issuing a recall, and urges patients who take these medications to continue to take them rather than stop without a doctor's recommendation, which could be dangerous.

But the FDA's action comes after Democrats leading an investigative subcommittee of the House Energy and Commerce Committee have ripped the FDA over its oversight of overseas generics manufacturers, in the wake of a withdrawal from the market of tainted generic heparin produced in China. The contaminated blood thinner is linked to at least 81 deaths. Committee Chairman John Dingell (D-Mich.) said the Ranbaxy warning letters confirm that policies FDA says it put in place to ensure the quality of low-cost drugs produced overseas still "are in shambles."

Rep. Bart Stupak (D.-Mich.), chairman of the investigations subcommittee, said FDA's Center for Drug Evaluation and Research has "abandoned their (sic) mission."

A Nov. 1, 2007, hearing brought to light shortcomings in FDA oversight of overseas pharmaceutical production. FDA allowed Ranbaxy -- the world's largest maker of generic drugs -- to submit key measures of its generic candidates' strength and quality that were conducted in Ranbaxy labs and by Ranbaxy employees. And in advance of approving generic drug marketing licenses to Ranbaxy, it's only conducted manufacturing inspections in 17% of the cases.

The list of medications produced at the two Ranbaxy plants and subject to FDA's warning contains 26 drugs, including low-cost versions of such mainstays as  pravastatin and simvastatin (commercially known as Pravachol and Zocor, used to lower cholesterol), metformin and glimeperide (for diabetes), acyclovir and ciprofloxacin (an antiviral and antibiotic medication) and gabapentin (known as Neurontin and used for epilepsy and some psychiatric conditions). Health insurers and the government have relied heavily on consumers' willingness to accept such generics to save money.

One of the drugs affected by the FDA warning, the antiviral drug Gancyclovir, is made only by Ranbaxy for the U.S. market. So FDA said it will continue to allow its import into the United States, while monitoring its quality.

-- Melissa Healy

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