Drugs

Trump Wants to Sue Opioid Drug Makers

President Donald Trump wants the federal government to bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair marketing practices to help fuel the U.S opioid abuse crisis. Speaking at a 3/1 White House summit on opioid addiction, Trump said he raised the issue with U.S. Attorney General Jeff Sessions. “Hopefully, we can do some litigation against the opioid companies,” Trump said. “I think it's very important because a lot of states are doing it, but I keep saying, if the states are doing it, why isn't the federal government doing it? So that will happen.”

On 2/27, Sessions announced a Prescription Interdiction and Litigation (PIL) Task Force to fight the prescription opioid crisis. The task force will “combat the opioid crisis at every level of the distribution system,” he said. “At the manufacturer level, the PIL Task Force will use all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices. The PIL Task Force will build on and strengthen existing Department of Justice initiatives to ensure that opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.” Sessions also directed the PIL Task Force to examine existing state and local government lawsuits against opioid manufacturers to determine what assistance federal law can provide in those lawsuits.

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