Blocker put on generic imports

FDA finds violations at drug plant in India
Thursday, February 26, 2009
BY SUSAN TODD
Star-Ledger Staff
Federal drug regulators will stop reviewing all new drug applications from Ranbaxy Laboratories if any studies on the medicines occurred at the company's plant in India, where they said officials fabricated data to make it appear that more than two dozen generic drugs met U.S. standards.

It is the second action the Food and Drug Administration has taken against Ranbaxy after years of investigating violations at the company's Paonta Sahib facility. Regulators said they only recently secured enough evidence to begin rejecting new drug applications from Ranbaxy, which has offices in Princeton.

Last year, the agency barred Ranbaxy from importing active pharmaceutical ingredients and more than 30 generic drugs made at Paonta Sahib and two other plants where regulators discovered violations of U.S. manufacturing requirements.

Ranbaxy is one of the world's largest manufacturers of generic medicines -- the less expensive copies of brand name prescription drugs. In 2007, the company had global sales of $1.5 billion, including $390 million worth of business in the United States.

"Ranbaxy will continue to cooperate with the Food and Drug Administration," the company said in a statement issued from its headquarters in India. "No effort or action will be spared to protect key (new drug applications) from Paonta Sahib."

Chuck Caprariello, a spokesman at the company's U.S. headquarters in Princeton, did not return telephone calls.

Regulators did not disclose how many drug applications Ranbaxy has pending before the FDA, but they said false information has been uncovered in some of those applications as well. "Companies must provide truthful and accurate information to the FDA, and when they don't, there will be serious consequences," said Deborah Autor, director of drug compliance.

Federal investigators said the company did not properly test the shelf-life and other safety measures of its drugs and then lied about the results. In one instance, company officials refrigerated drugs then indicated they had been stored at room temperature. At other times, the company lied about the number and frequency of the safety tests it conducted, investigators said.

To address the falsified data, the FDA invoked its application integrity policy against the Paonta Sahib facility. When the policy goes into effect against a company, regulators stop all substantive scientific review of any new or pending drug applications, essentially preventing Ranbaxy from putting any new products on the market. The policy will cover only applications containing data generated by workers at Paonta Sahib, regulators said.

Regulators said they would only resume reviewing drugs from Paonta Sahib if the company "assures the agency of the integrity and reliability of that data." The company will have to put in place a new quality-control plan and agree to inspections by outside auditors.

In all, regulators believe that 25 drugs affected by the problems likely reached the United States although since the import ban went into effect in September, it has likely been months since most of the pills were on pharmacy shelves.

Three drugs tested at the Paonta Sahib plant are still in U.S. circulation because they are manufactured at the company's New Jersey plant. Those drugs are a generic decongestant and generic versions of Merck's Zocor and Bristol-Myers Squibb's Pravachol. Both are widely used cholesterol drugs.

But regulators said the three medicines on the market likely underwent additional testing when they were transferred to the United States for the final phases of production, regulators said.

Despite the fraudulent data, regulators said they have no evidence that any of the drugs are dangerous and recommended that patients continue taking their prescriptions. "We've not uncovered any harm associated with Ranbaxy products currently marketed in the U.S.," said FDA Deputy Director Douglas Throckmorton. "We feel comfortable leaving those products on the market at this time."

In court documents filed last July, the Justice Department described "a pattern of systematic fraudulent conduct" at the Paonta Sahib plant that caused Ranbaxy's drugs to be too weak, too potent or lacking the advertised shelf life.

The Justice Department's investigation was disclosed in a court motion just days after Japanese drugmaker Daiichi Sankyo announced plans to acquire a controlling stake in Ranbaxy. Daiichi went through with the acquisition late last year.

The Associated Press contributed to this report.

Source: http://www.nj.com/