Senators’ Request Follows Revelations that McKinsey Consulted for FDA on Opioid-Related Projects While Working for Opioid Manufacturers Like Purdue Pharma


Washington (April 5, 2022) – U.S. Senator Edward J. Markey (D-Mass.) joined Senator Maggie Hassan (D-N.H.), Chair of the Emerging Threats and Spending Oversight Subcommittee and a group of thier colleagues in calling for an investigation into the failure of the consulting firm McKinsey & Company to disclose potential conflicts of interest when the company was simultaneously working with the Food and Drug Administration (FDA) on issues related to opioids and for numerous opioid companies, including Purdue Pharma. As the opioid crisis continues to devastate communities, the Senators are calling for a Health and Human Services Inspector General investigation into the FDA’s work with McKinsey and FDA’s contracting policies to ensure that contractors adequately disclose all potential conflicts of interest in the future. In addition to Senators Markey and Hassan, the letter was signed by Senators Patty Murray (D-Wash.), Chair of the Health, Education, Labor, and Pensions Committtee, Tammy Baldwin (D-Wisc.), Joe Manchin (D-W.Va.), Elizabeth Warren (D-Mass.), and Sheldon Whitehouse (D-R.I.).


“While working for clients involved in manufacturing, distributing, and selling opioids, McKinsey simultaneously worked on projects for FDA, including projects for the FDA center responsible for approving new drugs, like opioids. Government contracting databases show that since 2008, McKinsey has been hired by FDA on numerous occasions, earning more than $140 million,” the Senators wrote to Christi A. Grimm, Inspector General for the Department of Health and Human Services.


The letter follows Senator Hassan’s previous bipartisan efforts to push for answer from the FDA after learning from media reports that McKinsey did not reveal potential conflicts of interest to the FDA while they were contracted to work for the agency. Following the Senators’ outreach, the FDA responded that it had not known about McKinsey’s work with Purdue Pharma until media reports surfaced in 2021.


In their letter, the Senators continued, “Despite these reports, FDA did not conduct any additional contract reviews or discuss with McKinsey conflicts of interest and the firm’s failure to disclose them in earlier contract applications. Furthermore, it is unclear whether FDA has altered or improved its processes and procedures to prevent similar nondisclosures of conflicts of interest in future contracts.”


The Senators are calling on the Inspector General to review the actions of McKinsey and FDA as it pertains to these conflicts of interests and McKinsey’s failures to disclose them, and what actions the agency should take to help ensure that these failures don’t occur in the future.


Senator Hassan is leading efforts to ensure that the organizations that helped to fuel the devastating substance use disorder epidemic are held accountable. Senator Hassan joined her colleagues recently in calling on the DOJ to investigate whether members of the Sackler family personally engaged in criminal conduct in connection with Purdue Pharma’s admitted criminal wrongdoing in fueling the devastating opioid epidemic.


A copy of the letter can be found here.