The generic drug giant Ranbaxy falsified data on shelf life and efficacy on products made in their Paonta Sahib plant in India, the FDA said in a press conference today (Feb.26).

In response, the FDA has invoked a regulatory action called the Application Integrity Policy (AIP). Until the company complies with the FDA, the "FDA will stop all scientific review of pending applications at Paonta Sahib, and no new applications will be reviewed," said Doug Throckmorton, a supervisory medical officer at the agency.

Ranbaxy fudged data on the shelf life of the drugs by reporting that it had tested compounds at room temperature when products were actually stored in a refrigerator, said Deborah Autor, director of the Office of Compliance at the FDA. In addition, it tested data at different time points than claimed in drug applications. The FDA has found no evidence that the breaches affected the effectiveness or safety of the drugs, Autor said.

At this point, Ranbaxy "has the option of withdrawing [drug applications], or submitting them to a validity assessment," Autor added. Ranbaxy will have to submit to an independent audit of the Indian plant in order to ensure safety and efficacy.

Many of the drugs had already been barred from the US because the FDA issued an import alert on them in September 2008. The ban applied to more than 30 products marketed in the US.

The AIP also applies to drugs manufactured in Ranbaxy's Princeton, New Jersey plant that relied on safety data from the Paonta Sahib Plant. Those drugs include two cholesterol drugs and an antihistamine. However, because the drugmaker had to submit a battery of new test results directly from the New Jersey plant, which is not under investigation for data falsification, the applications for those drugs "rely very little, if at all, on these Paonta Sahib data," Autor said. Those drugs will not be pulled from the market.

Ranbaxy could not be reached for comment.

There are currently four generic drug companies on the FDA's AIP list. Since the policy was first formulated in the early 1990's, 12 companies, including innovative drug companies, have been subject to it.


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