McKinsey FDA Contract Under Fire at Hearing
Consulting firm McKinsey and Co. came under intense scrutiny 4/27 during a House hearing for its role in advising Purdue Pharm during the opioid epidemic while also being under contract to advise FDA. “We have learned that at the same time McKinsey was providing secret advice to Purdue to boost opioid sales, the firm was also consulting for the Food and Drug Administration — which oversees the opioid industry,” House Committee on Oversight and Reform chair Carolyn B. Maloney (D-NY) said in her opening statement. “In other words, McKinsey was advising both the fox and the hen house—and getting paid by both.”
The hearing comes on the heels of a committee report released earlier this month and entitled “The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Epidemic.” The report says the investigation determined that McKinsey consultants, including senior partners, frequently worked on FDA contracts while also working for opioid manufacturers including Purdue Pharma. “McKinsey’s conflicts, which the firm apparently did not disclose to FDA, raise serious questions about McKinsey’s ability to provide objective advice and its compliance with the terms of its contracts and federal law,” the committee says.
McKinsey global managing partner Bob Sternfels told the hearing that the committee’s recent report drew inaccurate conclusions. “Most importantly, McKinsey did not serve both the FDA and Purdue on opioid related matters,” he said. “As both McKinsey and the FDA have made clear, our work for the FDA focused on administrative and operational topics, including improvements to organizational structures, business processes, and technology. McKinsey did not advise the FDA on regulatory policy or on specific pharmaceutical products or classes of products, including opioids.”
Sternfels noted that in 2019 the company decided to end all work on opioid-specific business globally, acknowledging its opioid work “fell short of our standards” and deciding to be part of the solution instead. In 2021, the company engaged with state attorneys general across the country to reach a $600 million settlement to aid treatment, and recovery efforts across the country.
Maloney dismissed McKinsey’s defense of its relationship between FDA and opioid companies. She said there were obvious connections between McKinsey’s work for FDA and for opioid companies. “For example, in 2009, McKinsey advised opioid companies to, ‘band together’ to, ‘defend against strict treatment by the FDA,’” she said. “Then in 2011, McKinsey began working for the very FDA offices overseeing the opioid industry. The assignment was to set ‘strategic goals and objectives’ to improve drug safety and address adverse health impacts. Clearly, McKinsey should not be setting strategy for both drug companies and the FDA.”
Maloney said that since 2008, McKinsey has collected $140 million from FDA. Yesterday, during a Senate hearing on user fees, CDER director Patrizia Cavazzoni said the Center no longer has a consulting contract with McKinsey and the rest of the agency is not entering into any new contracts with the firm until the investigation is completed.