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A service for healthcare industry professionals · Sunday, December 15, 2024 · 769,126,124 Articles · 3+ Million Readers

Principal Deputy Assistant Attorney General Brian Boynton Delivers Remarks Announcing the Resolution of Criminal and Civil Investigations into McKinsey & Company’s Work with Purdue Pharma L.P.

Remarks as Prepared for Delivery

Good afternoon. My name is Brian Boynton. I am the Principal Deputy Assistant Attorney General for the Civil Division at the Justice Department. In that role, I serve as the head of the Civil Division. I am excited to be here from Washington, D.C., to join my U.S. Attorney colleagues to announce this important resolution.

In the Civil Division, we investigate and pursue civil and criminal violations of the Food, Drug, and Cosmetic Act through the Consumer Protection Branch, and we investigate and pursue civil violations of the False Claims Act through the Fraud Section of the Commercial Litigation Branch. We have used these criminal and civil tools to hold accountable a wide range of actors who played a role in fueling the opioid crisis in this country.

The resolution we are announcing today with McKinsey is part of the Civil Division’s broader commitment to combatting this crisis. As Chris already discussed, this resolution addresses McKinsey’s liability for various criminal violations. We were honored to partner with Chris and Josh’s offices on that aspect of the agreement.

The resolution we are announcing today also addresses McKinsey’s potential civil liability under the False Claims Act, and I want to add a few words about that aspect of the resolution. The False Claims Act is the government’s primary civil tool for holding accountable those who defraud the American taxpayers by submitting or causing the submission of false claims to federal healthcare programs and other federally funded programs. McKinsey US has agreed to pay over $323 million to resolve allegations that it violated the False Claims Act in two distinct ways.

First, the United States contends that McKinsey caused the submission of false claims to federal healthcare programs by advising Purdue Pharma to “turbocharge” its marketing of Purdue’s highly addictive opioid drug, OxyContin. As Chris previously described, McKinsey US advised Purdue to target healthcare providers who were already prescribing very large quantities of OxyContin, including prescribers who were writing opioid prescriptions for medically unnecessary uses. Notably, McKinsey US provided this advice without regard for the significant abuse and diversion that would result. Today’s civil resolution addresses the United States’ allegations that, by means of this conduct, McKinsey US knowingly caused the submission of false and fraudulent claims for OxyContin.

Second, the civil settlement resolves allegations that McKinsey US knowingly misled the Food and Drug Administration (FDA) by assigning consultants to work concurrently on both FDA projects and competitively sensitive projects for Purdue Pharma. In the course of seeking a contract from the FDA, McKinsey U.S. represented that it had a conflict-of-interest policy in place that would prevent its consultants serving the FDA from being assigned to another competitively sensitive project for a significant period of time following that FDA assignment. The FDA then awarded McKinsey US the first in a series of contracts relating to an FDA safety monitoring project. Despite its conflicts of interest policy, McKinsey nevertheless assigned the consultants working on the FDA matter to various Purdue projects around the same time. McKinsey has admitted that it did not disclose these facts to the FDA. The United States has alleged that, by means of this conduct, McKinsey knowingly submitted false claims to the FDA.

Today’s landmark resolution would not have been possible without the exceptional talent and dedication of a team of public servants from the Civil Division’s Consumer Protection Branch and Fraud Section, the U.S. Attorneys’ Offices for Massachusetts and the Western District of Virginia and the Medicaid Fraud Control Unit of the Virginia Office of the Attorney General. I am also grateful for the outstanding support on this investigation from our partners at the FDA, FBI, Criminal Division’s Computer Crimes and Intellectual Property Section’s Cybercrime Lab and Offices of Inspector General for the Department of Health and Human Services, Department of Veterans Affairs and Office of Personnel Management.

And last but not least, thank you to Chris and Josh for their partnership and leadership on this matter.

Thank you for the opportunity to speak with you today.

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