FDA/Justice Dept Investigates Generic Drug Maker For 'Faking Generic Drug Test', Including AIDS PEPFAR Drugs
"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."|
FDA Says Firm Faked Generic-Drug Tests
By Lyndsey Layton
Washington Post Staff Writer
Thursday, February 26, 2009
India's largest drugmaker has falsified laboratory tests for generic drugs that had been approved for sale in the United States, officials at the Food and Drug Administration say.
The FDA cited the fraudulent laboratory tests yesterday as it took the unusual step of stopping its review of all pending applications from Ranbaxy Laboratories. Federal investigators said the problems centered on the company's plant in Paonta Sahib, which has produced 25 drugs that have been approved by the FDA. Most of those medications are not thought to be on U.S. pharmacy shelves; since September, Ranbaxy has been prevented from exporting more than two dozen drugs to the United States.
The FDA is not seeking a recall, because regulators do not believe the drugs pose a health risk.
"There is no concern about the safety or efficacy of Ranbaxy's drugs on the U.S. market," said Deborah Autor, director of compliance at the FDA. The affected drugs include medications for high cholesterol and an antihistamine, but the FDA would not provide a specific list.
Patients using the drugs should not stop, said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.
But federal officials said they were concerned enough by their investigation into Ranbaxy's Paonta Sahib plant that they decided to halt approvals of any new or pending applications from the company. The agency will resume approvals if Ranbaxy improves its manufacturing processes, Autor said.
Since 2006, FDA investigators at the Paonta Sahib plant have turned up reams of laboratory tests that were inaccurate or missing information. In some cases, the company refrigerated samples of drugs that were supposed to be tested after being stored at room temperature or higher to demonstrate their shelf life, Autor said. Other tests that were supposed to be performed over a period of months to measure whether a drug lost potency over time were taken on the same day or within days.
Investigators also discovered laboratory records signed by employees who were not present when testing took place, she said.
"These and other findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct," the FDA wrote in a letter to Ranbaxy.
In a written statement, Ranbaxy said it is reviewing the FDA letter and would "respond appropriately in a timely manner." It pledged continued cooperation with the FDA.
Ranbaxy is India's biggest pharmaceutical company and one of the biggest producers of generic drugs in the world.
Yesterday's move is the second FDA sanction against Ranbaxy in six months. In September, officials blocked the company from importing 28 drugs made at its plants in Paonta Sahib and Dewas. The agency cited manufacturing problems including "inadequate sterile processing operations"; failure to prevent cross-contamination with compounds that can cause allergic reactions; and inadequate record-keeping.
The FDA had previously sent the company two warning letters, the first in 2006, noting that inspectors had found numerous deviations from good manufacturing practices.
As pharmaceutical manufacturing has burgeoned in countries such as India and China, public health advocates and lawmakers have grown increasingly concerned about the safety of imported drugs and the FDA's ability to police them.
"For the past three years, FDA possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior, but they continued to drag their feet while American lives were at risk," said Rep. John D. Dingell (D-Mich.) of the Committee on Energy and Commerce, which has been investigating Ranbaxy. "The Ranbaxy case is yet another example of the need for significant reform at the FDA."
FDA Bans Imports of 28 Indian-Made Drugs
Manufacturing Lapses Cited at 2 Plants
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.