Drugs

McKinsey & Co. Pays $650 Million in Opioid Case

Consulting firm McKinsey & Co. has agreed to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing of its OxyContin opioid. The settlement marks a significant development in the ongoing efforts to hold companies accountable for their contributions to the devastating opioid epidemic. McKinsey is charged with conspiring with Purdue to misbrand prescription drugs and destroying records to obstruct investigations.

The U.S. Department of Justice announced that McKinsey's resolution includes a five-year deferred prosecution agreement, the first time a management consulting firm has faced criminal charges for its advice leading to illegal actions by a client. According to the government’s information, McKinsey was charged with one felony count of knowingly destroying records, documents and tangible objects to impede, obstruct, and influence an investigation, and one misdemeanor count of knowingly and intentionally conspiring with Purdue to misbrand prescription drugs.

According to the government, between 2004 and 2019, McKinsey directed 75 consulting engagements with Purdue, including one (XXX DELETE XXX)advising the company on how to "turbocharge" OxyContin sales, even as concerns about the opioid crisis grew. In 2013, McKinsey’s “Evolve to Excellence” program helped Purdue target “high-value prescribers,” some of whom were prescribing opioids unsafely or unnecessarily, it says.

The settlement also mandates significant reforms at McKinsey. The firm will implement a compliance program, including policies to identify high-risk engagements, improved document retention procedures, and enhanced training, the government says. McKinsey also agreed to refrain from advising on the marketing, sale, or distribution of controlled substances for the next five years.

In a related matter, former McKinsey senior partner Martin E. Elling has been charged with obstruction of justice for destroying documents on McKinsey’s Purdue work amid growing legal scrutiny, the government says. He has agreed to plead guilty and faces up to 20 years in prison. Court documents revealed an email from Elling suggesting that McKinsey “eliminate all our documents and emails” related to Purdue.

The case was co-investigated by FDA’s Office of Criminal Investigations.

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