Drugs

Firms Ordered to Pay $834 Million Over Plavix Marketing

Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries have been ordered to pay $834 million to the state of Hawaii over marketing and promotion violations involving Plavix, a blood thinner used to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots. Hawaii attorney general Clare Connors filed the suit against the companies for violating the state’s unfair and deceptive practices laws.

According to evidence presented in court, the companies began marketing the drug to Hawaii physicians and consumers in 1998, “knowing that it was not effective for many patients, including Asian and Pacific Island patients,” a state news release says. “Defendants only began warning Hawaii physicians and consumers about this issue in March 2010, when the U.S. Food and Drug Administration (FDA) required them to place a Black Box warning on the label accompanying the drug.”

After a trial late last year, a court found that between 12/1998 and 3/2010, when FDA required the companies to disclose the warning, they sold 834,012 prescriptions “without including important information about the large percentage of patients who received less benefit or no benefit from Plavix due to their race and genetic makeup,” the release says. “Based on this evidence, the court determined the defendants ‘knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.’”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome