By David Brown
Washington Post Staff Writer
Wednesday, September 17, 2008
The Food and Drug Administration said yesterday that it was halting importation of 28 drugs made by the giant Indian generic drug maker Ranbaxy Laboratories because of manufacturing deficiencies at two of the company's plants.
Douglas Throckmorton, a physician with the FDA's Center for Drug Evaluation and Research, said there was "no evidence of harm to consumers" from drugs made at the Dewas and Paonta Sahib plants, both in India. He called the import ban "a preventive action."
FDA officials said numerous tests of the drugs have found they are not contaminated, sub-potent or unsafe and urged patients taking the drugs not to stop.
The drugs on the list include numerous antibiotics and antivirals, as well as medicines for high cholesterol, diabetes, high blood pressure, seasonal allergies and acne.
FDA officials said the action is not expected to disrupt availability of the medicines to U.S. consumers. All but one -- oral capsules of the antiviral drug ganciclovir -- are made by other companies. Supplies of that medicine will be allowed in after batch-by-batch testing and assurances by the company on the manufacturing process.
Ranbaxy is India's biggest pharmaceutical company and one of the 10 biggest producers of generic drugs in the world.
FDA officials walked a delicate line yesterday, stressing the seriousness of the violations while offering assurances that the risk to the public is essentially zero.
"We believe this step is warranted because of the seriousness and the extent of the violations," said Deborah M. Autor, director of the office of compliance at the Center for Drug Evaluation and Research.
She added, however, that "all the products that we have tested met specifications" and that there is "no reason" to consider them hazardous.
"The nature of the violations really relates to the [manufacturing] process," Autor said. "We did not find any defects in the products themselves."
The FDA inspects the factories of foreign drug companies seeking to sell products in the United States. Because the plants are on foreign soil, the agency has no direct regulatory control over them. Its only leverage is to ban importation of the substances.
The FDA had sent two warning letters, the first in 2006, informing Ranbaxy management that inspectors had found numerous deviations from "current good manufacturing process" -- the long list of rules and standards for producing drugs.
"Since then, we've done a lot of work with the company to correct the deficiencies," Autor said. But many persisted, she said, so the agency took the next step.
Among the problems were "inadequate sterile processing operations"; failure to keep certain areas from being contaminated with compounds that can cause allergic reactions in some people; and inadequate record-keeping.
The company will not be able to export any of the 28 drugs to the United States until the deficiencies are fixed. In the interim, the FDA also will not consider any new drug applications for substances made at the two plants.
Meanwhile, the Justice Department is investigating allegations that Ranbaxy submitted fraudulent data to the FDA as part of its application for approval to sell certain AIDS drugs to organizations funded by the Bush administration's $15 billion President's Emergency Plan for AIDS Relief.
One of the drugs on yesterday's list is the antiretroviral AZT.
"We are currently working through the PEPFAR interagency process and with our technical teams to evaluate the impact of today's FDA announcement on PEPFAR drug procurement and programming," a program spokeswoman said yesterday.