Drugs

California Man Pleads Guilty to Illegal Etizolam Sales

The Department of Justice says Paul Lamberty of Folsom, CA, pleaded guilty in a Massachusetts federal court to one count of conspiracy to defraud the United States and one count of the introduction of misbranded drugs with the intent to defraud and mislead. A department statement says Lamberty operated Web sites through which he sold the depressant etizolam to customers throughout the U.S.

FDA has not approved etizolam for use as a drug and thus it cannot be sold or prescribed in the U.S., the statement says. Despite the lack of approval, Lamberty bought drugs from suppliers in China, imported them into the U.S., and sold them with false labeling stating they were for research purposes only, the department says.

The charge of conspiracy to defraud the U.S. provides for a sentence of up to five years in prison, three years of supervised release, and a fine of $250,000, while the charge of introducing misbranded drugs carries a sentence of up to three years in prison, three years of supervised release, and a fine of up to $250,000. Sentencing has been scheduled for 12/13.

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