Drugs

DoJ Indictment on Unapproved Drugs

The Department of Justice has announced an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce an unapproved new drug, mail fraud and monetary transactions in criminally derived property.

According to the government, from 7/2019 through 4/2022 Sievert owned and operated Beauty Forever Florida (BFF), a business she used to order, purchase, import, receive, and distribute unapproved and misbranded drugs and medical devices. For example, Sievert allegedly distributed Innotox, Medytox, and Meditoxin, which contained botulinum toxin type A. The products were purchased from a Korean pharmaceutical company that did not have the required FDA approvals for distribution in the U.S., Justice contends. “Sievert made fraudulent representations on her BFF Web site to her customers, such as false and misleading claims that BFF’s products were ‘FDA approved,’ had ‘cleared customs,’ and had ‘guaranteed authenticity.’

If convicted, Sievert faces a maximum penalty of 20 years in federal prison for each mail fraud count (two counts), three years in federal prison for each count of introduction into interstate commerce of an unapproved new drug (two counts), and 10 years in federal prison for each money laundering count (two counts). The indictment is also seeking a forfeiture in the amount of at least $1.5 million, the proceeds of the charged criminal conduct.

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