Editor and Publisher
John H. Walker
If you are one of the many Americans with a cholesterol problem, the odds are that your physician has written you a prescription for atorvastatin — better known by the trade name Lipitor. In fact, until Nov. 30, 2011 when Pfizer's patent expired, there was only Lipitor.
Now, six firms are licensed by the Food and Drug Administration (FDA) to produce atorvastatin and the largest, India's Ranbaxy Pharmaceuticals, holds 44 percent of the market share with between 3 million and 4 million customers.
Last Friday, amid the wind down from Thanksgiving and the build-up of Black Friday, Ranbaxy quietly issued a recall for an undisclosed number of the calcium tablets.
The news slipped quietly under the public radar until this week and now, the company, which has a history of problems with the FDA, is facing increasing criticism over its recall, which reads:
"Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for Atorvastatin calcium tablets, in connection with its 10mg, 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength. The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA."
Ranbaxy does not disclose how many doses may be affected and refers visitors to its website to a list of batch numbers to see if they may be taking glass-tainted cholesterol medication.
And despite the recall, millions of people may continue taking
glass-contaminated medication. Ranbaxy's retail recall directed pharmacies not to dispense contaminated lots of the drug, but gave no directions to patients who have the drug at home.
"Patients are sandwiched between two groups who are being less than helpful: the FDA and Ranbaxy," said Lisa Gill, editor of prescription drugs at Consumer Reports.
A Food and Drug Administration spokeswoman couldn't explain to CNN why the recall didn't direct consumers to stop taking the drug even though patients might have received the contaminated pills.
Brian Henry, vice president of corporate communications for Express Scripts, has said his company would not exchange Ranbaxy atorvastatin for another brand. Additionally, a recorded message at Express Scripts says, "Ranbaxy, in conjunction with the FDA, has determined there are no safety concerns associated with continued use of atorvastatin in the patients' possession."
So, if there are no safety concerns, why issue the recall and instruct
pharmacies to stop dispensing the drug? No answers were forthcoming.
Pharmacists at several CVS pharmacies said it was all right to keep taking already-filled prescriptions of Ranbaxy atorvastatin, but the company would exchange it for another brand at a customer's request.
Ranbaxy, India's largest pharmaceutical company and the 12th largest generics maker in the world, has had quality problems in the past.
The FDA has accused the company of "a pattern of systemic fraudulent conduct," including taking
.fortune/index.htm>) shortcuts in crucial quality tests. In 2008, the FDA barred Ranbaxy from importing 30 drugs into the United States and last January, the company entered into a $500 million consent decree with the FDA for a bevy of violations.
According to the website Pharmalot.com, the list is long: a failure to keep written records showing that drugs had been manufactured properly; a failure to investigate evidence indicating that drugs did not meet their specifications; a failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; a failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date, according to the feds.
Ranbaxy also submitted false data in drug applications to the FDA, including backdating tests and submitting test data for which no test samples existed.
These actions violated the federal Food, Drug and Cosmetic Act, which meant many Ranbaxy drugs were adulterated, potentially unsafe and illegal to sell in the United States, the decree noted.