FDA Policy/General

Midwest Vet Supply Forfeits $10 Million for Misbranding

Midwest Veterinary Supply, based in Minnesota, has pleaded guilty to introducing misbranded veterinary drugs into interstate commerce and will pay more than $10 million in criminal fines and forfeiture. A Department of Justice news release says the company supplies prescription drugs for animals to veterinarians, farms, feedlots, and other businesses.

The department says that from 2011 to 2021 Midwest shipped prescription drugs from their non-pharmacy locations throughout the U.S. to end users that were not authorized to receive prescription drugs. Shipments from non-pharmacy locations to end-users and shipments to non-authorized locations are deemed misbranded, the statement says. It says the company shipped at least $10,150,014 worth of misbranded drugs to end users between 2011 and 2021.

“The law violated is designed, in part, to ensure that prescription drugs are kept within a controlled chain of distribution to prevent diversion and inappropriate use,” the department says.

Under a plea agreement, Midwest will forfeit $10,150,014 and serve between one and three years of probation. It will also pay $1 million to the Virginia Department of Health Professions and a $500,000 fine. The case was investigated by the FDA Office of Criminal Investigations and the Virginia State Police, with the assistance of the Virginia Department of Health Professions.

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