Drugs

Woodfield Pharma President Guilty of Drug Trafficking

Woodfield Pharmaceutical (Boca Raton, FL) president Adam P. Runsdorf has pleaded guilty to drug trafficking violations in the Eastern District of Texas federal court. According to the government, Runsdorf conspired with drug traffickers in Houston, TX to distribute misbranded and counterfeit cough syrup. The company also pleaded guilty to the same charges.

The government says Byron A. Marshall, who had earlier pleaded guilty with five other codefendants, “utilized Woodfield Pharmaceutical’s manufacturing facility and employees in Houston to produce more than 500,000 pints of counterfeit cough syrup. Marshall’s drug trafficking organization sold the counterfeit drugs across Texas, Louisiana, Mississippi, Alabama, Georgia, South Carolina, Tennessee, Wisconsin, California, Florida, Arkansas, and Ohio. Prices generally ranged from $100 to more than $1,000 per one-pint bottle.”

At Runsdorf’s request, Marshall paid Woodfield Pharmaceutical in cash only, and Woodfield employees mailed the cash directly to Runsdorf in Boca Raton. Runsdorf faces up to 20 years when he is sentenced.

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