Drugs

Insys Founder Pays $5 Million Over Opioid Scheme

NJ attorney general Gurbir S. Grewal has announced a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve allegations that he unlawfully bribed New Jersey doctors as part of a nationwide kickback scheme to boost sales of the company’s opioid drug Subsys. This is the first settlement in any state’s civil lawsuits against corporations and executives involved in manufacturing and fraudulently marketing opioid drugs, a NJ release says.

“The state’s 2017 complaint alleged that Kapoor directed and approved a campaign to fraudulently market Subsys — a sublingual fentanyl spray approximately fifty times stronger than heroin and one hundred times more potent than morphine — to boost sales in New Jersey and elsewhere,” the release says. “Although the U.S. Food and Drug Administration approved Subsys only for the narrow purpose of treating breakthrough pain in opioid-tolerant cancer patients, the state alleged that Kapoor arranged for Insys to bribe healthcare professionals to write Subsys prescriptions for other purposes and at higher doses than appropriate.”

In 2019, a federal jury in Boston convicted Kapoor and four other Insys executives of racketeering conspiracy in connection with the nationwide Insys bribery scheme. In 1/2020, Kapoor was sentenced to five-and-a-half years in federal prison.

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