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 United States, because, in all instances except for one, enough other suppliers can help meet demand for the medications.
FDA also said today that it has no evidence that the generic drugs involved are actually defective and emphasized that the agency is taking steps in advance to ensure no more products are allowed in until problems are fixed.
"The FDA has no reason to believe 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.
Based in India, Ranbaxy has already been under investigation for allegedly selling fake or substandard medications. 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. Ranbaxy 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.
On Tuesday, the FDA issued two warning letters and an import alert for drugs made by the manufacturer.
The drug maker issued a statement in response, saying, "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. We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs."
Ranbaxy also said it will review the letters and continue to cooperate with the FDA to resolve problems.
The FDA's latest announcement 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.
"The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud," said Rep. John Dingell, D-Mich., in a Tuesday statement. "This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health."
Dingel and fellow Michigan Democrat Bart Stupak previously wrote a letter to the FDA in late July to find out whether the FDA permitted the drugs to be sold after learning that the company's data on the medications was fraudulent. Today the lawmakers again placed blame on the FDA, saying the FDA has had information for three years about misconduct at Ranbaxy.
"It's a very, very serious violation," Stupak said. "A very, very serious action here. But why did it take over three years?"
But at the FDA, Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, defended the agency's actions.
"When we first learned about this problem in 2005, we contacted the company, we issued letters to them and we started working with them to correct the manufacturing problems," Throckmorton said. "We continued those inspections, continued those interactions when we had another set of inspections earlier in the year we found deficiencies that required this step."
"I think it's very important for FDA to ramp up its ability to inspect internationally as we import more and more drugs in this country," said Dr. Peter Lurie, deputy director of health research at Public Citizen. "It's good that they are doing it in this case, but the fact is that it's a small fraction of the drugs they can adequately inspect and things can certainly slip through the borders as well."
Still, Lurie said there was "a tension between FDA's statement of seriousness and slow pace at which they have gone after them." He added, "What we're seeing are a series of fairly serious infractions, not keeping production lines separate, not being able to assure that the parts are sterile, not having proper inspection records. All of these are very important if you want to have a truly first-class drug product."
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 Tuesday.
The FDA also said that the generics Ranbaxy made in other factories are not problematic. According to Throckmorton, the agency inspected those other facilities and did not find problems. Throckmorton also told consumers on Tuesday "not to discontinue their drug therapy, as such action could seriously jeopardize their health."
