FDA says India plant falsified generic drug data

In its second action in six months against Ranbaxy's Paonta Sahib plant, the FDA invoked its Application Integrity Policy, which is usually invoked over concerns about the integrity of data in drug applications.

In September, the FDA issued an import alert barring entry of generic drugs produced at the plant in northeastern India and two others owned by Ranbaxy. That order remains in effect.

A man who answered the phone at the company's offices in Gurgaon, Haryana, India, said no one was available for comment. No one immediately answered an e-mail sent Wednesday to the company's U.S. corporate offices in Princeton, New Jersey.

Under the Application Integrity Policy, the most recent action, the FDA has stopped all scientific review of any new or pending drug approval applications containing data from the Paonta Sahib plant.

In a letter sent Wednesday to the company, the agency alleged that data submitted from the Ranbaxy plant contained falsified information -- including lies that safety tests were conducted, lies that drugs had been kept at room temperature when in fact they had been stored in refrigerators, and lies about the shelf life of some drugs.

"Companies must provide truthful and accurate information in their marketing applications," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement on the FDA Web site. "The American public expects and deserves no less."

An investigation is under way, but the FDA said it has no evidence that drugs manufactured at the plant do not meet quality specifications.

In a written statement e-mailed to CNN, a spokesperson said the company had just been notified of the action. "Ranbaxy will analyze the letter and other information fully and respond appropriately in a timely manner," it said.

"The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing," it added.

Deborah Autor, director of the drug evaluation center's Office of Compliance, said there is no reason to believe Ranbaxy drugs on U.S. shelves pose any safety threat. She said all 80 samples tested met application specifications.

"We feel comfortable leaving those products on the U.S. market at this time," she said.

The FDA said it has approved some 25 drug applications that contain data from Paonta Sahib. The applications affected by Wednesday's announcement are for approved drugs made for the U.S. market, drugs pending approval but not yet on the market, and certain drugs manufactured in Ranbaxy's Ohm Laboratories in New Jersey, which relied on data from the Paonta Sahib plant.

Three generic drugs were produced at Ohm Laboratories: simvastatin (Zocor) and pravastatin (Pravachol), both cholesterol-lowering drugs called statins, and the antihistamine loratadine (Claritin).

The four plants in India that make drugs approved for distribution in the United States have been inspected more than 20 times since 2005, the FDA said.

The FDA advised patients to talk with their doctor before considering stopping any medications.

Article Source

You may also be interested in reading:

Gardasil Vaccines: Side Effects and Death

Wyeth's Use of Medical Ghostwriters Questioned

More Kids Are Taking More Meds Than Ever Before

Prescription Drugs Kill 300 Percent More Americans Than Illegal Drugs

Links Between Cholesterol Drug Vytorin and Cancer

Ban on Gifts to Doctors Sought

U.S. Lawmaker Questions FDA, Cites Industry Ties

Drugging Grade Schoolers With Statins

Allergy Drug Singulair Linked to Suicides

Contaminated Blood Thinner Causing Death

Deliberate Heparin Contamination

Toxic Tamiflu