Drugs

Former McKinsey Exec Pleads Guilty in Opioid Case

The Department of Justice (DoJ) says a former McKinsey & Company senior partner pleaded guilty 1/10 to obstructing justice related to his work on opioids with Purdue Pharma. A department statement says Martin Elling, an American citizen who lives in Bangkok, Thailand, pleaded guilty to a one-count information charging him with knowingly destroying records with the intent to impede, obstruct, and influence the investigation and proper administration of a matter within the jurisdiction of the DoJ. He will be sentenced 4/4 and faces a maximum penalty of 20 years in prison, the notice says.

Last month, McKinsey agreed to pay $650 million to resolve criminal and civil investigations into its consulting work with opioid manufacturers.

Department officials say Elling’s guilty plea is a significant step in their ongoing efforts to address the full scope of misconduct that fueled the country’s opioid epidemic.

The FDA Office of Criminal Investigations (OCI) helped to investigate the case and the statement quotes OCI Metro Washington Field Office special agent in charge George Scavdis that “knowingly destroying records and documents to impede a government investigation into the unlawful prescribing of opioids impairs the ability of law enforcement to do its job and endangers the public health.”

The DoJ says Elling was the director of the client services team for some 30 of McKinsey’s engagements with Purdue and had a senior, relationship-fueled role with the Evolve to Excellence program that included McKinsey advising Purdue on how to “turbocharge” the sales pipeline for OxyContin by, among other strategies, intensifying marketing to high-value prescribers.

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