The Food and Drug Administration is cutting ties with McKinsey and Co. after the consulting giant failed to disclose potential conflicts of interest over its simultaneous work with the agency and opioid makers.
A House Committee on Oversight and Reform report released last month, detailing initial findings from the committee’s investigation, spurred the FDA’s move. Among the more damning revelations: that several McKinsey consultants worked on FDA contracts while simultaneously working for opioid makers.
“[The] 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,” committee chairwoman Rep. Carolyn Maloney said in a statement.
The report suggested that McKinsey leveraged its FDA contracts to influence private sector business. In 2009, for example, the company noted in a pitch to opioid makers that it had “developed insights into the perspectives of the regulators themselves.”.
It also found that McKinsey provided opioid advice to the Trump administration, which made its way to the Department of Health and Human Services and FDA leadership. In 2018, a McKinsey consultant suggested a memo to HHS Secretary Alex Azar should mention the “important societal benefit” of opioids.
The FDA’s move to cut ties with McKinsey comes in the wake of its controversial approval of Biogen’s Alzheimer’s drug Aduhelm, staff burnout during COVID-19 and tension between agency staff and the White House over booster shots and other pandemic initiatives. It has also faced an accumulating backlog in drug manufacturing site inspections and ongoing calls to address its accelerated approval pathway. As a result, most observers believe the FDA needs to repair its damaged reputation and rebuild public trust.
With the agency’s McKinsey ties brought to light, lawmakers are grilling its leaders over its contracting processes. “How is the FDA adjusting its contracting processes going forward to ensure that it is aware of publicly reported information about apparent conflicts of interest with major companies to which it is awarding tens of millions of dollars in contracts?”
Asked Senator Maggie Hassan at a hearing last month.
Hassan added that it “strains credulity to think that nobody at the FDA involved with McKinsey between 2019 and 2021 had any idea that the company had major potential conflicts of interest based on news reports in major publications.”
McKinsey has argued that its work with the FDA and with Purdue wasn’t a conflict of interest. At a congressional committee hearing in late April, McKinsey managing partner Bob Sternfels noted “we did not comment on the safety of drugs such as OxyContin or any other opioid in our work with the FDA.”
He did, however, acknowledge the broader consequences of the situation. “While our intent was not intent to fuel an epidemic, we failed to recognize the broader context of what was going on in society around us,” he said.