The Food and Drug Administration says it will not issue new contracts to the consulting firm McKinsey and Co. pending the outcome of investigations into whether the company failed to divulge potential conflicts of interest over its work for both the FDA and opioid manufacturers.
A top official at the FDA announced the decision at a Senate hearing Tuesday after lawmakers had pressed the agency over its work with the global consultant firm.
The FDA currently has no contracts with McKinsey and it anticipated “that further contracts will not be issued pending the outcome of the investigations,” said Patrizia Cavazzoni, director for the Center for Drug Evaluation and Research for the FDA.
The House Oversight Committee is currently investigating McKinsey’s consultant work with the FDA and its links to opioid manufacturers, and lawmakers have called for the Health and Human Services Inspector General to probe the FDA’s work with McKinsey and the agency’s contracting policies.
Democratic Sen. Maggie Hassan of New Hampshire grilled FDA officials at Tuesday’s hearing over why the agency did not question McKinsey’s contract given media reports about its links to opioid makers.
Hassan said 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.”
“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?” Hassan said at a hearing of the Senate Committee on Health, Education, Labor and Pensions.
The FDA’s announcement came a day before the managing partner of McKinsey is due to testify before Congress over a new congressional report that accused the company of failing to divulge conflicts of interest due to its work for Purdue Pharma, the manufacturer of the opioid OxyContin, and the FDA’s office that regulates the safety of medications.
The committee’s investigation “uncovered significant, years-long conflicts of interest at McKinsey, resulting from its work for the federal government at the same time that it was advising opioid manufacturers,” the report said.
The committee said documents show that one opioid manufacturer, Purdue Pharma, “explicitly tasked McKinsey with providing advice on how to influence the regulatory decisions of the U.S. Food and Drug Administration (FDA), another McKinsey client,” according to the report.
McKinsey declined to comment on the FDA’s decision to stop issuing new contracts to the firm.
As to the congressional report released earlier this month, the firm says it will review the report by the House Committee on Oversight and Reform and will continue to cooperate with lawmakers “to address further questions.”
“We are steadfastly committed to protecting our clients’ confidential information and guarding against conflicts of interest,” the company said in a recent statement.
In February 2021, McKinsey agreed to pay nearly $600 million to settle allegations by 49 states that its work for large opioid manufacturers helped “turbocharge” sales of the drugs, contributing to an addiction epidemic that has caused more than 400,000 deaths.
McKinsey has said it believes its past opioid work was “lawful.” It said it agreed to the settlement “without finding or admission of wrongdoing or liability of any kind.”
The state of Massachusetts released internal emails and other documents in a 2019 court filing detailing McKinsey’s role in helping push the sale of opioids as a consultant for Purdue Pharmaceuticals, the maker of OxyContin.
McKinsey worked with Purdue for 15 years, starting in 2004. Purdue has pleaded guilty to three felonies as a result of conduct spanning a decade — 2007 to 2017 — while it was working closely with McKinsey.
McKinsey & Co. also has come under scrutiny in Congress over its work with both the Pentagon and powerful Chinese state-owned enterprises that have supported China’s naval buildup in the Pacific and played a role in Beijing’s efforts to extend its influence around the world.
McKinsey has said it abides by U.S. laws on federal contracting and that it has extensive internal rules to prevent conflicts of interest and to protect clients’ information.