Drugs

Former Drug Company President Convicted

The former president of Cumberland Distribution, Inc., a Houston, Texas-based drug company, was convicted by a Tennessee federal court jury of conspiracy, 15 counts of mail fraud, and one count of making false statements to FDA in connection with a 32-month, $50 million drug diversion scheme. An FDA Office of Criminal Investigations (OCI) announcement says that Jerrod Smith faces up to 20 years in prison and a $250,000 fine for each mail fraud count, plus up to five years in prison and a $250,000 fine for the conspiracy and false statement convictions.

OCI says that evidence at the trial established that Smith and a partner purchased millions of dollars of prescription drugs from unlicensed suppliers who had previously purchased them from patients in and around New York and Miami. Smith had the drugs shipped to Cumberland’s Nashville warehouse where they were cleaned, sorted, repackaged, and shipped to independent pharmacies around the country. Generally, OCI says, the diverted drugs included products used to combat HIV/AIDS, antipsychotic medications, antidepressants, blood pressure medications, diabetes medications, and others.

Numerous pharmacies reported problems with drugs purchased from Cumberland’s Nashville warehouse including prescription drug bottles containing the wrong medicine, the wrong dosage information, and foreign objects inside. At trial, several witnesses testified that at least one bottle of prescription drugs sold by Cumberland contained candy mints.

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