Drugs

Indivior Paying $289 Million for Unlawful Suboxone Marketing

The Justice Department says a Virginia federal court sentenced Indivior Solutions to pay $289 million in criminal penalties in connection with a previous guilty plea related to its marketing of Suboxone. The judge entered the sentence under a plea agreement.

Altogether, a Justice Department statement says, Indivior Solutions will pay $600 million to resolve its civil and criminal liability in the matter.

“In total, the payments made by Indivior Solutions and its parent companies … along with payments made under a 2019 resolution with Indivior’s former parent, Reckitt Benckiser Group, and criminal penalties paid pursuant to plea agreements with two former Indivior executives will exceed $2 billion,” the statement says. “That amount represents the second-largest monetary resolution obtained by the Department of Justice in a case involving an opioid drug.”

Indivior Solutions admitted to making false statements to the Massachusetts Medicaid program related to the relative safety of Suboxone film around children, the department says.

The company also agreed to prospective measures including disbanding the Suboxone sales force and taking steps to prevent promoting the drug to healthcare providers at a high risk of inappropriate prescribing.

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