Drugs

Illinois Sues Insys Therapeutics Over Off-label Marketing

Illinois attorney general Lisa Madigan has filed a lawsuit against Insys Therapeutics for “deceptively marketing” and selling Subsys, described as a highly addictive opioid drug indicated for treating breakthrough cancer pain. Madigan says the company illegally marketed the pain killer to physicians for treating non-cancer patients for off-label uses like back and neck pain in an effort to increase profits. She alleges that Insys focused on doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists treating cancer patients, who are the intended recipients of the drug. “Insys’ irresponsible promotion of a prescription opioid is particularly concerning as studies indicate that people who abuse prescription opioids frequently move on to using heroin as a cheaper and more readily available alternative,” a news release says.

The lawsuit follows an Illinois investigation that revealed that doctors across the country were rewarded for prescribing Subsys to non-cancer patients for off-label uses, including payments for sham speaking events and dinners at expensive restaurants, Madigan says. The lawsuit seeks to permanently bar the company from selling its products in Illinois and impose financial penalties for violating the Consumer Fraud Act. Madigan’s office continues to investigate other opioid manufacturers for similar practices.

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