>A Congressional panel is investigating whether Indian drug giant, Ranbaxy Laboratories Limited, falsified drug data to the U.S. Food & Drug Administration (FDA) and whether the FDA knowingly allowed Ranbaxy to distribute suspect drugs in the United States.

Congressional investigation

The House Committee on Energy and Commerce, chaired by John Dingell (D-MI) and Bart Stupak (D-MI), is investigating whether the FDA allowed Ranbaxy to distribute suspect drugs in the U.S. and whether the company falsified data concerning the safety of those drugs. According to news reports, federal prosecutors have demanded that the Indian pharmaceutical giant hand over documents relating to FDA submissions. While Ranbaxy is allegedly complying with the U.S. requests, it says that the allegations are “baseless.”

In the past, the U.S. government has alleged that Ranbaxy used unapproved ingredients and diluted ingredients in some of its drugs. The FDA had issued Ranbaxy a warning letter over manufacturing violations that were discovered in one of its Indian factories in 2006. The two have been trying to address the issue ever since.

Who is Ranbaxy Laboratories Limited?

Ranbaxy Laboratories Limited is an India’s largest pharmaceutical company with a presence in 49 countries and a U.S. division located in Princeton, New Jersey. The company manufactures generic drugs such as the Merck’s cholesterol drug Zocor and provides the U.S. market with a variety of active pharmaceutical ingredients.

Preemption issues

If the FDA is found to have knowingly allowed Ranbaxy to distribute suspect drugs in the U.S., it is likely to have an effect on preemption issues that will be in front of the U.S. Supreme Court later this year. The Court is deciding whether consumers who are injured by a drug have the right to sue the manufacturer if the FDA was ultimately responsible for approving the drug.

Although the Bush Administration believes that injured consumers should not have the right to sue manufacturers, many others disagree and point to situations like this where the FDA allegedly failed to do its job.