Drugs

Taro Pays $205 Million in Generic Price Fixing Settlement

Taro Pharmaceuticals has agreed to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs, according to the U.S. Justice Department. A two-count felony charge was filed in eastern Pennsylvania federal court that charged the company with participating in two criminal antitrust conspiracies, each with a competing manufacturer of generic drugs and various executives, a release says.

The government has also approved a deferred prosecution agreement where Taro has admitted participating in a conspiracy with Sandoz from at least as early as 3/2013 and continuing until at least 12/2015. “Taro USA and its co-conspirators agreed to fix prices, allocate customers, and rig bids for numerous generic drugs, including medications used to prevent and control seizures and treat bipolar disorder, pain and arthritis, and various skin conditions,” the government says.

This is the fifth company to date to be charged in connection with antitrust violations in the generic pharmaceutical industry. In May, Apotex agreed to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug sellers to artificially raise the price of pravastatin, a cholesterol-lowering drug. In March, Sandoz agreed to pay a $195 million criminal penalty under a deferred prosecution agreement (see earlier story). In 12/2019, Rising Pharmaceuticals agreed to pay over $3 million for conspiring to fix prices for benazepril HCTZ (see story). And in 6/2019 Heritage Pharmaceuticals agreed to pay over $7 million over price fixing related to diabetes drug glyburide (see story).

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