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Investigation Reveals that Ranbaxy Repeatedly Submitted Fake Results to FDA

Written by Ankin Law Office

Generic drugs account for the vast majority of prescription drugs sold in the country – but what happens when generic drugs are found to be unsafe because the manufacturer skipped the necessary approval steps?

As this CBS News report shows, generic drugs account for eighty percent of the drugs prescribed to Americans. Like brand name drugs, generic drugs must approved by the FDA, which often requires years of testing. Many generic drugs are made in India and, as a recent lawsuit revealed, a leading generic drug manufacturer, Ranbaxy, often skipped the required steps for approval of its generic drugs.

In 2004, Ranbaxy executive Dinesh Thakur became aware of signs of drug quality problems and noticed that data on generic anti-retroviral drugs distributed in Africa “appeared to be fabricated.” After several months spent documenting the fraud, Mr. Thakur realized that the problem permeated “hundreds of drugs, dozens of countries… [in a systematic] pattern of missing and fabricated data, substandard ingredients and cGMP violations.”

Thakur told CBS News, “The data’s important because the FDA or other agencies globally look at that information to give you marketing authorization to sell the drug. We started getting the files, and, lo and behold, we find that none of that exists in the first place. … It means that we’ve gotten approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent.”

Thakur informed Ranbaxy executives in 2005 that his investigations revealed that Ranbaxy’s drugs for illness such as AIDS, heart problems, and infection had no proof to support assertions that they were effective. When the company did nothing to correct the problem, Thakur blew the whistle and informed the FDA of Ranbaxy’s problems.

According to CBS News, an FDA investigation found that Ranbaxy had a “persistent … pattern” of submitting “untrue statements” and auditors found over 1,600 data errors on at least 15 new generic drug applications. As a result of their investigation, the FDA concluded that Ranbaxy drugs were “potentially unsafe and illegal to sell.” Earlier this year a $500-million fine was imposed on Ranbaxy.

The safety and efficacy of generic drugs is of utmost important to patient health and consumer safety. The Chicago product liability lawyers at Ankin Law Office, LLC are dedicated to protecting consumers from dangerous and defective products and helping the victims of unsafe products obtain full and fair financial recovery from any and all responsible parties, including generic drug manufacturers. Because we have significant experience handling class action lawsuits regarding unsafe pharmaceuticals and defective medical devices, we are familiar with the complex legal issues that these kinds of lawsuits generally involve.

Contact us at (312) 600-0000 for more information on unsafe pharmaceuticals and generic drug liability.

Categories: Product Liability