Drugs

Guilty Pleas in Drug Kickback Conspiracy

The Department of Justice (DoJ) says an Ohio doctor and a former drug company representative have each pleaded guilty to one count of conspiracy to solicit, receive, offer, and pay healthcare kickbacks. A department statement says Deepak Raheja, Hudson, OH, a doctor specializing in psychiatry and neurology with a practice in Cleveland, OH, and Frank Mazzucco, Dublin, OH, who was a regional business manager supervising sales representatives for Avanir Pharmaceuticals in the region where Raheja practiced, were involved in the scheme in which Raheja wrote prescriptions for a drug to patients who did not have the condition in exchange for money and other items of value.

The DoJ says Avanir manufactured Nuedexta, which is FDA approved solely to treat pseudobulbar. Court documents state that between 2/2011 and 7/2016, Raheja, Mazzucco, and other codefendants conspired to increase the number of prescriptions Raheja and other coconspirators wrote for Nuedexta in exchange for the payment of monetary kickbacks and other items of value.

According to the documents, Avanir promoted Nuedexta through a speaker’s bureau that Raheja joined in 2/2011. He reportedly gave some 211 presentations on the drug between 10/2011 and 4/2016 and was paid about $331,550 from Avanir. At the time, he wrote about 10,086 Nuedexta prescriptions, the highest in the country.

The DoJ says that as part of the conspiracy Mazzucco and other codefendants incentivized doctors to write Nuedexta prescriptions through various means, such as arranging speaker’s bureau programs, which were mostly social events; honoraria payments; the falsification of sign-in sheets from speaking engagements to maximize payments, and providing food and beverages to doctors and their office staff.

As part of a plea agreement, the DoJ says, Raheja has agreed to a sentence of 30 months in prison, surrendering his medical license, at least $1,178,460.40 in restitution, and a fine to be determined.

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