How McKinsey used its FDA connections to help opioid manufacturers: New congressional report
Following reports that McKinsey engaged in abusive and deceptive business practices to stoke the flames of the opioid epidemic, the House Oversight Committee on Wednesday released a new report documenting how the consulting company leveraged its work with the FDA to drive new business with opioid manufacturers.
Documents uncovered by the committee also show how opioid juggernaut Purdue Pharma explicitly tasked McKinsey with providing advice on how to influence the FDA’s decisions.
“In 2011, at least four McKinsey consultants working on a $1.8 million FDA contract to enhance drug safety and address ‘the adverse impact of drugs on health in the US’ were simultaneously working for Purdue — including on projects designed to persuade FDA of the safety of Purdue’s opioid products. One project involved writing ‘scripts’ for Purdue to use in a meeting with FDA on the safety of pediatric OxyContin,” the 53-page report says.
The committee’s investigation also uncovered 37 FDA contracts that were staffed by at least one McKinsey consultant who simultaneously or previously worked for Purdue, and McKinsey failed to disclose its relationships with opioid manufacturers to FDA.
Many of the details regarding these unusual relationships between McKinsey, FDA and opioid manufacturers are just being unearthed now, even as they were forged a decade ago.
And while the FDA does not have any current contracts with McKinsey, and the consulting company agreed in February to pay $573 million to 53 attorneys general to resolve allegations that it aggressively promoted the sale of higher doses of opioids, the congressional report sheds new light on what McKinsey did and how it used FDA.
From 2008 to today, McKinsey worked on 76 contracts for the FDA, and the agency has paid McKinsey more than $140 million since 2008, the congressional investigators found.
At the same time, three senior McKinsey consultants — Navjot Singh, Jeff Smith, and Sastry Chilukuri — worked on multiple projects for both Purdue and FDA.
In the case of Smith, who was “frequently cross-staffed” on FDA and Purdue projects, “One project involved the effectiveness of Purdue’s REMS for OxyContin, which was at the time being implemented by the FDA office Mr. Smith was advising on drug safety,” the report says.
Smith later complained to Chilukuri that Chilukuri had overrepresented the capabilities of the FDA’s drug safety tracking system, known as Sentinel, and that the false claim that Sentinel can be “used to assess the efficacy of opioids” ended up in a speech by former FDA commissioner Scott Gottlieb.
In 2017, Smith also began serving as one of the lead McKinsey partners on a new FDA contract, but two days earlier, Smith had started another engagement at Purdue, at the specific request of Purdue’s VP of business, according to the report.
In a statement on Wednesday, McKinsey defended its prior work, noting that it stopped advising clients on opioid-related business in 2019:
McKinsey’s work for the FDA has focused on administrative and operational topics, including improvements to organizational structures, business processes and technology. We have not advised the FDA on regulatory decisions or on specific pharmaceutical products.