Drugs

Unlicensed Wholesaler Sentenced to Prison

A Florida federal judge has sentenced Marina Sievert to two years in federal prison for mail fraud and introducing into interstate commerce a foreign unapproved new drug. As part of her sentence, the court entered an order of forfeiture in the amount of $1.5 million, the proceeds of the charged criminal conduct, and ordered Sievert to pay $20,000 in criminal fines. Sievert had pleaded guilty to the charges in the FDA Office of Criminal Investigations case on 6/21.

According to court documents, from 7/2019 to 4/2022, Sievert owned and operated Beauty Forever Florida, Inc. (BFF), which she used to order, purchase, import, receive, and distribute unapproved and misbranded drugs and medical devices. “For instance, Sievert distributed Innotox Medytox and Meditoxin, which contained botulinum toxin type A, a highly potent toxin that could cause the disease botulism,” a Justice Department release says. “Sievert acquired these products from a Korean pharmaceutical company that did not have the required approvals … for distribution in the U.S.”

The government also contends that Sievert made fraudulent representations on her BFF Web site that the products were “FDA approved,” had “cleared customs,” and had “guaranteed authenticity.” Sievert distributed the unapproved new drugs across the U.S. via the mail, it says.

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