FDA bans import of meds from drug maker

September 16, 2008 1:01:22 PM PDT
In a major drug safety alert, the Food and Drug Administration announced Tuesday that the U.S. can refuse to import dozens of generic drugs taken by millions of Americans that are made by a major drug manufacturer in India. People taking any of 30 generic medications, such as the generics of Cipro, Alavert and Claritin, all made at two Ranbaxy plants in India, could be affected by today's alert. But the FDA said that drug shortages are not expected in the U.S., because, in all instances except for one, enough other suppliers can help meet demand for the medications.

FDA also said Tuesday that it has no evidence that the generic drugs involved are actually defective and stressed that the agency is taking pro-active steps to ensure no more products are allowed in until problems are fixed.

"FDA has no reason to belive that drugs from these two plants already in the U.S. drug supply pose a safety problem," said Deborah M. Autor, director of the office of compliance at the FDA's Center for Drug Evaluation and Research.

On Tuesday, the FDA issed two warning letters and an import alert for drugs made by Ranbaxy, a company that has already been heavily scrutinzed. Based in India, the Ranbaxy Company has already been under investigation for allegedly selling fake or substandard medications. In late July, lawmakers John Dingell and Bart Stupak wrote a letter to the FDA to find out whether the federal agency permitted the drugs to be sold after learning that the company's data on the medications was fraudulent.

In February 2007, the Justice Department raided the manufacturer's U.S. offices in New Jersey. Last year, Ranbaxy recalled 73 million doses of a generic version of the pain pill Neurontin.

In addition to popular drugs Ranbaxy has already been making, the company also has contracts to make generic Lipitor and Nexium, but it is unclear if the company had started making those drugs as of yet.

This company also received money from the Bush administration to make HIV drugs for Africa, and there are allegations that the data for some of those drugs was also not up to par.

The latest announcement from the FDA again ignites debate about the safety of drugs imported from other countries, following on the heels of reports about the tainted blood-thinning drug, heparin, that was imported from China. India has become a major source of generic drugs, exporting nearly $6 billion worth of them in just the last year.

One drug, the antiviral Ganciclovir oral capsules, won't be detained entering the country while problems are being corrected because Ranbaxy is the only company that makes it, the FDA said on Tuesday.

Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, told consumers on Tuesday "not to discontinue their drug therapy, as such action could seriously jeopardize their health."


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