Drugs

Teva Pays $450 Million to Settle Kickback Cases

Teva Pharmaceuticals has agreed to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). In one kickback settlement, Teva has agreed to resolve separate allegations that it conspired with other generic drug manufacturers to fix prices for pravastatin, clotrimazole and tobramycin, according to a Justice Department release. “Teva USA previously entered into a deferred prosecution agreement with the Justice Department’s Antitrust Division to resolve related criminal charges,” it says. “Teva USA paid a criminal penalty of $225 million and admitted to conspiring with three other generic drug companies to fix prices on certain generic drugs. Under the civil settlement announced today, Teva agreed to resolve allegations that the benefits it received under its price-fixing scheme constituted illegal kickbacks.”

The other resolution involves allegations that Teva “violated and conspired to violate the AKS and FCA by paying Medicare patients’ cost sharing obligations (copays) for multiple sclerosis drug Copaxone from 2006 through 2017, while steadily raising Copaxone’s price,” according to the government.

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