Drug Maker Sanofi Heavily Fined Over Efforts to Limit Sales of Plavix Generic


sanofi_plavixFrench drug maker Sanofi was fined 40.6 million euros ($52.8 million) by France’s competition regulator for trying to limit sales of generic versions of the blood thinner drug Plavix (clopidogrel).

According to Bloomberg News, France’s Competition Authority acted on a complaint by Teva Pharmaceutical Industries Ltd., a major manufacturer of generic medicines. In a statement on its website, the Competition Authority said that Sanofi’s sales force cast doubts on the efficacy of generic versions of Plavix in conversations with doctors and pharmacists. The regulator said Sanofi representatives urged doctors to write prescriptions that do not allow a generic to be substituted for Plavix, or, if the doctor prescribes a generic, to prescribe Sanofi’s generic, not a competitor’s version.

The U.S. Food and Drug Administration (FDA) approved Plavix to help “reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.” But recent research has cast doubt on whether Plavix helps prevent repeated strokes, whether taken alone or in combination with aspirin. The Plavix-aspirin combination can increase the likelihood of serious gastrointestinal bleeding and death, according to a study published in The New England Journal of Medicine.

In 2010, the FDA added a black box warning to the Plavix label, after the agency found that about 3 percent of the U.S. population is unable to properly metabolize the drug and would not get the same benefit from the drug as those who metabolize it effectively.

In the U.S., numerous lawsuits have been filed against the drug maker over allegations that Plavix causes adverse reactions such as stomach bleeding, gastrointestinal hemorrhage, and cerebral hemorrhage. Other suits allege that Sanofi and Bristol-Myers engaged in deceptive marketing in its claims that Plavix is superior to aspirin for specific treatments, according to Law360. Aspirin costs a fraction of the prescription drug’s price.