The Food and Drug Administration (FDA) has approved eighteen generic drugs manufactured by Ranbaxy Laboratories Ltd. even as the United States was investigating whether or not the company fabricated data in order to get their drugs approved. Many are calling for the agency to freeze the drug applications until the investigation has reached a conclusion. Ranbaxy is India’s largest drug maker and brought these eighteen generic drugs to the market, including Zyrtec and the cholesterol drug Pravachol. They also currently have sixty-five medicines on the market in the United States. Though the eighteen drugs have been approved, Ranbaxy decided not to sell three of the products and six of the products are not being sold yet due to patents held by brand-name drug makers.
According to a court motion brought last month, the government is investigating allegations such as conspiracy, false statements and healthcare fraud. The Justice Department asserts the company’s drugs may have too much or too little of their main ingredients. The government is also probing whether data showing Ranbaxy’s generic drugs are absorbed at the same rate and extent as the originals were falsified. This information is used by the FDA to decide whether the drug copies should be approved for sale, as opposed to requiring the full clinical trials that are needed for clearance of new brand-name treatments.
Reports show the FDA has been aware of these allegations against Ranbaxy for about eighteen months. Legislators and former FDA officials are wondering why the FDA trusted Ranbaxy’s data on the new products even after learning of the allegations. The agency had also suspended action on Ranbaxy’s applications for drug approval made at one of the company’s plants after the agency found “significant deviations” from required manufacturing practices at the facility. The Energy and Commerce Committee, which oversees the FDA, is trying to discover why the agency did not act on the information. A former FDA commissioner says the agency should have halted the approval of the drugs since the agency could not be confident of the truthfulness and reliability of the information provided.
On July 3, the federal government asked a U.S. District Court Judge in Maryland to compel Ranbaxy to turn over audits completed by a contractor, which the company later agreed to do. Ranbaxy, however, denies the claims in the motion citing the fact that the FDA collected more than two hundred samples of products produced by the company, all of which were found to meet required specifications. The FDA has refused to comment since the investigation is continuing.
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