Drugs

Nurse Sentenced for Insys Fentanyl Kickbacks

The Justice Department says that Heather Alfonso, who worked as an advanced practice registered nurse in a Connecticut pain management center, has been sentenced by a Connecticut federal judge to three years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. A department statement says that as part of her work, Alfonso prescribed various controlled substances including Subsys, a fentanyl-based sublingual spray approved by FDA solely for managing breakthrough pain in cancer patients. Subsys was manufactured and sold by Insys Therapeutics.

The statement says Alfonso was responsible for some $2.5 million in claims and was the highest prescriber of the drug in Connecticut. Interviews with her patients showed that many of them did not have cancer, the statement says, and had taken the drug to treat chronic pain. Medicare and many private insurers will not pay for Subsys unless the patient has an active cancer diagnosis and an explanation that the drug is needed to manage the cancer pain.

The department says that between 1/2013 and 3/2015, Insys paid Alfonso some $83,000 to act as a “speaker” at over 70 dinner programs. It says that in many instances the programs were attended only by Alfonso and an Insys sales representative or by staff at the facility at which she worked and her friends, none of whom were licensed to prescribe controlled substances.

Last June, Insys agreed to pay $225 million to resolve criminal and civil investigations of the company.

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