In Letter to Senators, FDA Says it Failed to Follow Up After Media Reports Revealed McKinsey’s Potential Conflicts of Interest in Relation to Opioid Crisis

WASHINGTON – In a letter to Senators, including Maggie Hassan (D-NH), Chuck Grassley (R-IA), and Sheldon Whitehouse (D-RI), the Food and Drug Administration (FDA) said that it did not push for answers after learning from media reports that McKinsey & Company did not reveal potential conflicts of interest to the FDA while they were contracted to work for the agency, which included working simultaneously for the FDA and opioid manufacturers such as Purdue Pharma. The original letter sent by the Senators to the FDA was also signed by Senators Ed Markey (D-MA), Joe Manchin (D-WV), and Elizabeth Warren (D-MA).

To read the response that the FDA sent to the Senators, click here.

Reports show that the FDA hired McKinsey a number of times beginning in 2008, during which the firm appeared to be particularly involved with the FDA’s principal division for approving certain classes of drugs, including prescription opioids. At the same time, McKinsey was consulting for private-sector clients, such as Purdue Pharma, that were the targets of this new regulatory process.

In their letter to the FDA seeking answer on McKinsey’s potential conflicts of interest, the Senators asked the FDA when it became aware of the consulting firm’s contracts with opioid manufacturers, and whether those disclosures prompted a review McKinsey’s existing contracts for conflicts of interest.

ln response, the FDA said it only became aware of McKinsey’s potential conflicts of interest after reports from the media earlier this year. The agency also said that because the existing contracts between the FDA and McKinsey did not specifically involve opioids, the agency did not feel additional oversight of McKinsey was necessary.

“FDA became aware in early 2021 when the information was reported in the media. FDA had previous contracts with McKinsey that covered the broad scope of the Agency’s activities with drug products, for example, those focused on improving Agency processes or creating visibility into supply chains,” wrote the FDA in the letter to the Senators. “However, FDA has not consulted McKinsey about processes or review issues associated with any specific drug product or specific product class, including opioids. As none of FDA’s contracts were specifically related to opioids, no additional contract reviews or outreach to McKinsey occurred.”

The FDA also told the Senators that McKinsey was not transparent with the agency about its potential conflicts of interest: “FDA is not aware of any disclosures made by McKinsey vis-a-vis [Organizational Conflict of Interest] in relation to these orders. FDA cannot speculate on why McKinsey did not consider any actual or apparent [Organizational Conflict of Interest] to be sufficient to require reporting,” wrote the FDA.

“We continue to see a lack of transparency from McKinsey. By not disclosing its client lists to the FDA, which included the big-name opioid manufacturers that helped fuel this epidemic, the consulting firm put the health of Granite Staters and Americans at risk,” Senator Hassan said. "We must do everything we can to address the substance misuse crisis and ensure that the FDA is doing all it can to prevent future conflicts of interest that could hamstring our response to the substance misuse crisis. Big Pharma is endangering the lives of Granite Staters, and our government must hold those responsible to full account. I will continue to push the FDA to answer for how such a potential conflict of interest could have occurred.”

“Transparency and accountability are critical when federal agencies sign contracts and put taxpayer money on the line. FDA, like every other federal agency, ought to do the utmost to ensure contractors disclose even potential conflicts of interest before opening up government coffers. Both McKinsey and the FDA needed to do better here,” Senator Grassley said.

“We’ve lost hundreds of thousands of Americans to overdose.  The FDA ought to treat conflicts of interest involving opioid makers with deadly seriousness,” said Senator Whitehouse.

Senator Hassan is leading efforts to ensure that the organizations that helped to fuel the devastating substance use disorder epidemic are held accountable. Senators Hassan and Whitehouse previously sent a letter to the Department of Justice highlighting the Department of Justice’s past failure to proceed with serious criminal charges laid out in a 2006 memo by federal prosecutors against Purdue Pharma and expressed their concern that “the Department will once again let connected lawyers obtain a settlement that does not adequately address the harms caused by the company.” Senators Hassan and Whitehouse also have repeatedly asked the Department for the 2006 prosecution memo and related information about the choice not to proceed with stronger action against Purdue and the Sacklers, which the Senators have still not received.  Senators Hassan and Whitehouse also joined their colleagues in urging the United States Bankruptcy Court for the Southern District of New York to reject Purdue Pharma’s recent motion requesting $34.7 million in employee bonuses, including $5.4 million for its top executives, as part of Purdue’s Chapter 11 reorganization plan.

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