Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.
The agency said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand. Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination.
The company has declined to say where the drug was manufactured or why the problem occurred, but a spokeswoman for the F.D.A. said Thursday that the company would stop making the pill’s active ingredient, which is made in India, until the investigation is completed.
The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called “unprecedented in scope,” after they identified a host of manufacturing problems at the company’s plants in India and the United States, and concluded that Ranbaxy had submitted false data in drug applications to the F.D.A..
The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting United States standards, although it was allowed to continue making products — including the generic version of Lipitor — at other plants.
The F.D.A. spokeswoman, Sarah Clark-Lynn, said the affected lots were not made at “the same facilities whose conduct gave rise to the consent decree.” Nonetheless, she said in an e-mail Monday, “the consent decree provides the F.D.A. with additional tools to address violations for other Ranbaxy facilities.”
A spokesman for Ranbaxy declined to comment beyond an informational statement on the company’s Web site.
Some drug manufacturing experts said Ranbaxy’s latest troubles highlight the disparities in oversight of plants in the United States versus those overseas. “I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, who previously worked in manufacturing and global outsourcing for pharmaceutical companies, including Searle and Pharmacia. “But my confidence is not that high when we are getting products from outside the country.”
He pointed to studies that have shown the F.D.A. inspects foreign generic manufacturing plants about once every seven to 13 years, compared with once every two years for domestic manufacturers. A law passed over the summer will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of which country they’re in.
Allan Coukell, director of medical programs at the Pew Health Group and an expert on drug safety, said the new law would level what he described as an uneven playing field, but “it’s incumbent on F.D.A. to hire the staff and to make the shift to a risk-based inspection system.” Under the law, fees collected from generic manufacturers will help pay for more inspectors.
Mr. Basu said the law, called the Generic Drug User Fee Amendments of 2012 and known as Gdufa (Gah-doofuh) was a step in the right direction, but fixing the problem would require more than simply hiring more people. “This is a very difficult and complex system, and how do we ensure the integrity of this supply chain?” he said. “I don’t know how much Gdufa will help.”
Ranbaxy has held a significant share of the market for generic Lipitor, also known as atorvastatin, since it became one of the first companies to sell it after Pfizer lost patent protection for the top-selling drug last November; another company, Watson, sold a generic version that was authorized and manufactured by Pfizer. In October, Ranbaxy’s product accounted for 43 percent of prescriptions for atorvastatin, a widely used drug to lower cholesterol levels, according to an analysis by Michael Faerm, an analyst for Credit Suisse who used prescription data from the research firm IMS Health.
In its statement on Thursday, the F.D.A. said it did not expect a shortage of atorvastatin. Erin Fox, who tracks drug shortages as director of the Drug Information Service at the University of Utah, said drugs in pill form have long shelf lives and suppliers can keep large quantities in stock. Other generic manufacturers with approval to sell the drug include Apotex, Dr. Reddy’s Labs, Mylan, Sandoz, and Teva, according to the F.D.A. Web site.
Ranbaxy has posted a list of the recalled lots on its Web site, and has warned that patients should not stop taking the drug without guidance from their doctor. The lot numbers are found on the side of Ranbaxy pill bottles and the company advised patients to check with their pharmacist if customers received pills in a container dispensed by the pharmacy.
The agency said the potential for injury because of the contamination appeared to be low and “if any adverse events are experienced, they would be temporary.”
Ranbaxy, a Generic Drug Maker, Stops Making Cholesterol Pill
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Ranbaxy, a Generic Drug Maker, Stops Making Cholesterol Pill
