FDA Blocks Imports From Large Generic Drug Supplier
The U.S. Food and Drug Administration initiated a block on Tuesday of more than 30 generic drugs produced by Ranbaxy Laboratories Ltd. ““ India’s biggest pharmaceutical company.
The FDA said two of the pharmaceutical company’s factories were in poor shape. The block includes generic versions of popular drugs including Cipro and cholesterol pill Zocor.
Earlier this year, FDA inspections revealed violations that could be linked to contamination, allergic reactions and other complications in two plants in India. Deborah Autor, director of FDA’s compliance office, said Ranbaxy has failed to take the proper steps to correct the problems.
Additionally, the FDA said no new drugs will be admitted for sale by Ranbaxy until the violations are corrected.
Concern about Ranbaxy has been growing since FDA inspectors first uncovered quality problems at one of its factories in 2006.
The block was made as a precaution, but the FDA told consumers not to worry about taking Ranbaxy products that are already in their possession as repeated testing hasn’t found any contaminated products. Also, it would be hard for a patient to tell if drugs were made at the suspect factories or at one of Ranbaxy’s numerous other factories in 11 countries.
"We have seen no evidence of harm to consumers from drugs produced at these two facilities and have no reason to believe that drugs already in the U.S. from these plants pose a safety problem," said FDA deputy drug director Dr. Douglas Throckmorton.
Among the blocked drugs: the antibiotics ciprofloxacin and clarithromycin; the antiviral acyclovir; cholesterol-lowering simvastatin and pravastatin; and the diabetes drug metformin.
"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research (CDER). "The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed." The Warning Letters issued today document the results of FDA investigations at these two sites.
Ranbaxy is also under investigation on the grounds that it submitted fraudulent data to the FDA that allowed sale of substandard drugs. Ranbaxy has vigorously denied that allegation, calling it part of a conspiracy to undermine the company.
—
On the Net: