Drugs

Guilty Plea in Compounded Rx Kickback Scheme

The Department of Justice says Robert Schneiderman, Langhorne, PA, pleaded guilty in New Jersey federal court to two counts of an indictment charging him with one count of conspiracy to commit healthcare fraud and one count of conspiracy to violate the Anti-Kickback Statute. A department statement says that from 2014 to 2016 Schneiderman and his conspirators used Main Avenue Pharmacy, a mail-order pharmacy with a storefront in Clifton, NJ, to run a fraud and kickback scheme involving compounded drugs like scar creams, pain creams, migraine medication, and vitamins. He was the president of Main Avenue Pharmacy and founder and CEO of its corporate parent.

The department says the scheme revolved around identifying compounded drugs that would yield exorbitant reimbursements from federal and commercial health insurers.

On compounded medications alone, it says, Main Avenue received over $34 million in reimbursements from healthcare benefits programs. Some $8 million of that was paid by federal payers. Schneiderman himself earned over $400,000 through the course of the scheme, the government says.

Conspiracy to commit healthcare fraud carries a maximum penalty of 10 years in prison, while conspiracy to violate the Anti-Kickback statute carries a maximum penalty of five years in prison. Both counts also are punishable by a maximum fine of $250,000 or twice the gross gain or loss from the offense, whichever is greatest. Sentencing is set for 9/16, the department 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