Drugs

Physician Convicted in Insy Therapeutics Scheme

A New York physician, Gordon Freedman, has been convicted for participating in a scheme to receive bribes and kickbacks through sham educational programs (“speaker programs”) from Insys Therapeutics in exchange for prescribing millions of dollars’ worth of Subsys, a fentanyl-based spray. “As a jury of his peers has now found, Dr. Gordon Freedman sold out his patients by prescribing a powerful and dangerous fentanyl opioid in exchange for bribes from the pharmaceutical company that manufactured that drug,” a government release says.

Freedman received over $300,000 in speaker program fees from Insys in exchange for prescribing large volumes of Subsys. He was found guilty of one count of conspiracy to violate the Anti-Kickback Statute, which carries a maximum term of five years in prison, one count of violating the Anti-Kickback Statute, which carries a maximum term of 10 years in prison, and one count of conspiracy to commit honest services wire fraud, which carries a maximum term of 20 years in prison. Sentencing is scheduled for 3/19/2020.

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