House committee finds McKinsey overlapped contracts with FDA, opioid makers

A new report released by the House Committee on Oversight and Reform has revealed that consultants with McKinsey & Co. worked on US Food and Drug Administration (FDA) contracts at the same time they consulted with opioid manufacturers.

According to the findings of the interim staff report, McKinsey engaged in overlapping consulting work with FDA and opioid manufacturers such as Purdue Pharma, in some cases using some of the same consultants. The committee also found evidence that consultants with McKinsey learned information about FDA’s regulation of opioids and shared that information with colleagues at McKinsey working for opioid clients.

“Today’s report shows that at the same time the FDA was relying on McKinsey’s advice to ensure drug safety and protect American lives, the firm was also being paid by the very companies fueling the deadly opioid epidemic to help them avoid tougher regulation of these dangerous drugs,” said committee Chair Carolyn Maloney (D-NY).

At least 22 consultants were staffed at both FDA and with opioid manufacturers working on related topics, sometimes at the same time, the committee said. McKinsey worked on a project for Purdue that included a contract in 2009 to “defend against strict treatment by the FDA” and put the same consultant from that project in an FDA office that was overseeing drug safety monitoring at FDA. Four consultants at McKinsey were simultaneously working with Purdue in 2011 on “projects designed to persuade FDA of the safety of Purdue’s opioid products” at the same time they were contracted by the FDA on a project to enhance drug safety and “the adverse impact of drugs on health in the US,” according to the report.

These overlapping contracts sometimes involved senior partners at McKinsey, occurred over more than a decade, and across 37 FDA contracts. “McKinsey’s failure to disclose or meaningfully address these conflicts appears potentially to have violated federal law and contract requirements and may have contributed to one of the worst public health epidemics in our nation’s history,” according to the report.

Maloney also noted McKinsey used its position as a federal contractor to create new private sector business or benefit their existing clients in the private sector, which violated the company’s own confidentiality policies. “These serious conflicts of interest also impacted McKinsey’s advice to high-level government officials, with members of McKinsey’s government health care practice incorporating feedback from consultants serving private sector opioid clients and altering work product in ways that appeared to serve those clients’ interests,” she said.

During the Trump administration, McKinsey attempted to influence public health officials, including the US Department of Health and Human Services (HHS) Secretary and FDA Commissioner, the committee found. According to the report, HHS Secretary Alex Azar received a memo from McKinsey in 2018 written by a consultant advising the secretary to emphasize the “important societal benefit” of opioids; the consultants who wrote the memo worked with Purdue, and one consultant had recommended sales strategies to Purdue to increase the sale of opioids. Another document showed McKinsey consultants had discussed a claim that another McKinsey consultant had made up that former FDA Commissioner Scott Gottlieb referenced in one of his speeches.

The firm has also discussed deleting Purdue files in an effort to keep them from being discovered in Purdue lawsuits, the report stated, with one senior partner at McKinsey sending an email to himself as a reminder to delete Purdue documents.

Maloney noted the scope of the report is limited to opioid manufacturers because McKinsey has “failed to provide most of the key documents that would allow the Committee to fully assess how its consulting practices and conflicts of interest have affected the health and safety of the American people.” The firm has also “repeatedly certified” they had no conflicts of interest with regard to their work with FDA, which may carry civil or criminal penalties, the committee said.

“McKinsey’s conduct raises significant questions about the lack of regulation over consulting companies that advise both the federal government and private sector clients,” the report concluded.

Maloney said she intends to have McKinsey’s global managing partner testify on the conflicts of interest in front of the committee. “I remain committed to uncovering the full scope of McKinsey’s conflicts of interest across the federal government and advancing legislative solutions to safeguard the health and security of the American public,” she said.

The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Epidemic

House committee finds McKinsey overlapped contracts with FDA, opioid makers

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