FDA Policy/General

Ex-Blackstone Sales Director Gets 51 Months Sentence

A Parkland, FL man who was the sales director for Blackstone Labs was sentenced 3/11 to 51 months in prison for conspiring to defraud FDA and conspiring to distribute anabolic steroids. According to a Justice Department release, a jury convicted James Boccuzzi in December for his and the firm’s involvement in illegally manufacturing and distributing anabolic steroids that were controlled substances under the Designer Anabolic Steroid Control Act.

“The evidence also showed that Boccuzzi and his co-conspirators quickly sold off other Blackstone products containing certain stimulants after they received an FDA Warning Letter notifying them that the products were unlawful to sell as dietary supplements,” Justice says. “Further, the evidence showed that the conspirators concealed the sales of other products containing research chemicals despite knowing that the products could not legally be sold as dietary supplements.”

Aaron Singerman and Phillip Braun, who co-founded and operated Blackstone Labs, had earlier pleaded guilty to distributing unapproved new drugs and conspiracy to distribute anabolic steroids, the government says. Each was sentenced to 54 months in prison and ordered to forfeit $2.9 million and $3 million, respectively. “In total, eight individuals and three companies were convicted of felonies in connection with the activities of Blackstone Labs and ordered to forfeit a total of nearly $8 million,” 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

Read more

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