Consulting firm’s work with both drug makers and federal drug regulators represents a conflict of interest.
The head of McKinsey & Company has denied that the consulting firm illegally concealed its work for drug manufacture Purdue Pharma while simultaneously acting as an advisor for the Food and Drug Administration (FDA). Since 2008, McKinsey consulted for the federal agency’s drug regulation division and has been involved in numerous FDA projects. It was also brought to the public’s attention in 2019, that McKinsey long engaged in work for opioid drug makers. Simultaneously working for drug companies and the federal agency represents an obvious conflict of interest.
Three years ago, some of McKinsey’s clients were revealed when the firm handed over a list that included Purdue Pharma and Johnson & Johnson, among others. It was also revealed that during the time McKinsey consulted for Purdue, it helped to convince the FDA to relax a proposed opioid safety program.
Bob Sternfels, McKinsey’s global managing partner, apologized for the company’s business relationship with Purdue. He testified before a congressional committee after documents including “how to turbocharge opioid sales” that were previously hidden from the FDA were released. The report indicated that over 15 years “at least 22 McKinsey consultants, including senior partners, worked for both FDA and opioid manufacturers on related topics, including at the same time.”
The FDA claims it did not know McKinsey was simultaneously working for the Oxycontin maker and the chair of the House oversight committee, Carolyn Maloney, called the firm’s conduct “among the worst I have seen in my years in government. 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.”
Maloney said that McKinsey consulted for and “designed strategies for Purdue and other companies to drive up opioid painkiller sales, paving the way for the explosion of addiction and overdoses. Some of the advice McKenzie provided is absolutely shocking beyond belief.”
Jessica Tilliman of George Washington University Law School explained, “Contractors have the obligation to disclose potential conflicts, and then the government has an obligation to figure out how to deal with it.” In other words, McKinsey should have disclosed the potential conflict sooner and allowed the FDA to decide how to move forward. Maloney suggested McKinsey had “broken the law” by not disclosing its work for the drugmakers to the federal authorities. This also did not allow for the agency to choose how to best react to this information.
Sternfels said his firm was “merely protecting client confidentiality.” He has denied there was a conflict because, he said, “McKinsey was advising the FDA on implementing technology solutions and performance management not drug regulation.” Sternfels acknowledged, however, that McKinsey “should not have advised Purdue to increase OxyContin sales. We fully recognize that it fell short of our standards. While our intent was not to fuel an epidemic in any of our work, I think we failed to recognize the broader context of what was going on in society around us.”
Sources:
McKinsey denies illegally hiding work for opioid-maker Purdue Pharma while advising FDA
McKinsey, FDA are Responsible for Disclosing & Considering Conflicts
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