Drugs

New York AG Targets Opioid Companies, Sacklers

New York attorney general Letitia James has filed what she says is the nation’s most expansive lawsuit against the manufacturers, Sackler family, and distributors of opioids for their role in the nation’s opioid epidemic. The suit, which expands an earlier complaint against Purdue Pharma, alleges that through years of false and deceptive marketing, and by ignoring their duty to prevent the unlawful diversion of controlled substances, six national prescription opioid manufacturers, the Sackler family, and four national prescription drug distributors are largely responsible for creating the opioid epidemic.

A James news release says the suit breaks new ground by setting forth an extensive set of facts alleging that prescription drug distributors failed to exercise their duty to detect and report diversion of opioids through poorly designed, poorly resourced, and poorly executed suspicious order monitoring programs.

Named ithe complaint are Purdue Pharma and its affiliates, members of the Sackler family (owners of Pursue) and trusts they control, Janssen and its parent company Johnson & Johnson, Mallickrodt, Endo, Teva and Allergan. The distributors are McKesson, Cardinal Health, Amerisource Bergen, and Rochester Drug Cooperative.

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