FDA allows criminal drug company to market generic Lipitor drug containing tiny shards of glass

Wednesday, December 05, 2012 by: Ethan A. Huff, staff writer
Tags: heart drugs, glass shards, FDA

(NaturalNews) For the second time in fewer than four months, India-based drug giant Ranbaxy Pharmaceuticals Inc. has issued a formal recall on its drug atorvastatin calcium, which is a generic version of the popular cholesterol drug Lipitor. According to reports, the company, which has been the subject of U.S. Food and Drug Administration (FDA) investigations since 2006 because of fraud, publicly released more than 40 lots of the tainted drug, which this time was found to contain tiny pieces of glass.

The recall affects all 10, 20, and 40-milligram doses of the drug produced by Ranbaxy, according to an announcement posted on the company's website. The vast majority of the tainted lots are reportedly composed of 90-pill bottles in each of these sizes, while at least three of the recalled lots include 500-pill bottles. Ranbaxy claims its 80-milligram doses of the drug are not affected by the recall.

"Ranbaxy is proactively recalling the drug product lots out of an abundance of caution," wrote company spokesman Chuck Caprariello in a generic statement about the recall, which was reportedly issued to the public a full two weeks after Ranbaxy first notified pharmacies. "This recall is being conducted with the full knowledge of the U.S. FDA," he added, refusing to offer any further comments.

Patients who take generic atorvastatin calcium for cholesterol in the affected doses are being urged to contact their pharmacies immediately to inquire about whether or not their medication is tainted. Since neither the FDA nor Ranbaxy know just how many bottles of medicine may contain tiny shards of glass, it is best for patients to exercise caution and avoid taking generic Lipitor pills from bottles that may be included as part of the recall.

FDA allowed Ranbaxy to sell generic Lipitor in U.S. with full knowledge of company's illegal activities

As reported by the New York Daily News (NYDN), the FDA first launched an investigation into Ranbaxy back in 2006 after learning about the company's questionable manufacturing processes and what appeared to be illicit behavior. The FDA eventually found that Ranbaxy was not only failing to test the shelf life of its products, which was putting patients in danger, but had also lied about its drug safety tests, which prompted the agency to issue sanctions against Ranbaxy.

In 2008, the FDA took further action against Ranbaxy by blocking the import of nearly 30 of the company's drugs from India into the U.S. The U.S. Department of Justice (DOJ) also demanded at the time that Ranbaxy surrender internal documents revealing what it alleged to be blatantly fraudulent behavior. According to reports, Ranbaxy had repeatedly lied to regulators about the ingredients and formulations of several of its drugs.

The situation worsened in 2009 when the FDA finally decided to block all new applications from Ranbaxy to sell drugs in the U.S. But on November 30, 2011, the day Lipitor was to lose its patent protection, the FDA suddenly, and without a reason, reversed its position and allowed Ranbaxy to begin producing a generic version of the drug and shipping it into the U.S.

This means the FDA knowingly and willingly put Americans in danger by apparently caving to pressures from Ranbaxy, India's largest drug company, to remove the sanctions and once again allow imports of dangerous generic drugs into the U.S. It remains to be seen whether or not anyone at the FDA will be held criminally responsible for this blatant disregard for public safety.

Sources for this article include:

http://www.nydailynews.com

http://news.yahoo.com

http://www.industryweek.com