Drugs

2 Charged in Insys Fentanyl Kickback Scheme

The Justice Department says a 16-count indictment charges that two Florida men conspired to pay and receive kickbacks in connection with prescribing an Insys fentanyl spray. Those charged were pain management doctor Steven Chun and former Insys sales representative Daniel Tondre.

A department statement says that Insys sales representatives were compensated, in part, with sales commissions based on Subsys prescriptions written by practitioners in their territories. It says the company actively marketed Subsys to pain management doctors, including Chen, to increase the number of prescriptions the doctor wrote.

“Insys used a sham speaker program to conceal and disguise kickbacks and bribes paid to high-prescribing doctors, like Chun, to induce them to prescribe Subsys,” the statement says. “Insys sales representatives, like Tondre, arranged speaker programs that were often only attended by family and friends, or repeat attendees, and included falsified or forged signatures of attendees. Insys also bribed large Subsys prescribers, like Chun, by hiring individuals, often close to the doctors, to work as an Insys liaison to facilitate the approval of insurance forms for Subsys, including those submitted for Medicare patients.”

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