House committee investigators found that consultants from consulting firm McKinsey & Company advised opioid producers while the company was on a federal contract with the Food and Drug Administration’s drug approval unit, a scheme that lawmakers say may have violated federal conflict of interest rules, according to an interim report released Wednesday.
According to the report released by the House Oversight Committee, McKinsey consultants have reportedly taken advantage of their work with the FDA to attract business from companies like Purdue Pharma, one of the leaders in opioid drug development. And according to the preliminary report, McKinsey consultants appear to have tried to influence officials to benefit their opioid clients, raising questions about the company’s firewall between public procurement and private sector work.
While the FDA relied on McKinsey’s advice to ensure drug safety and protect American lives, the company was also paid by the same companies that fueled the deadly opioid epidemic by allegedly helping defend opioid producers against stricter regulation of these dangerous drugs. Rep. Carolyn Maloney, DN.Y., chairman of the committee, wrote in a statement.
Maloney called McKinsey’s behavior particularly “strange given its central role in driving a public health crisis that has killed half a million Americans.”
McKinsey, in response to the new release, wrote in a statement that it “will review the report” and “continue to work with the committee to resolve further issues”, but defended its work for the FDA and its opioid clients, saying that it is obliged to protect itself against conflicts of interest.
In the statement, McKinsey wrote that it is reviewing its potential conflicts and “will not do the job” if these potential conflicts “cannot be resolved properly.” It said its work for the FDA was administrative and operational, “including improvements to organizational structures, business processes, and technology,” not related to regulatory decisions or specific pharmaceutical products.
But the firm also admitted in the statement that its previous opioid work in the private sector – which it stopped in 2019 – even though it was legal, “lacked the high standards we set for ourselves” and that it settled with all 50 state attorneys in general to “provide rapid, meaningful support to communities across the United States that have been hit by the opioid crisis.”
In particular, the new House Committee report sheds light on questions about the firm’s conflict of interest policies, including details of at least 22 McKinsey consultants who allegedly worked for both the FDA and opioid manufacturers on related topics, sometimes at the same time.
For example, in 2011, at least four McKinsey consultants working on a $ 1.8 million FDA contract worked to address “the adverse effects of the drug on U.S. health” for Perdue at the same time, “including on projects designed to persuade FDA of the safety of Purdue’s opioid products, ”the committee found, according to the report.
In 2017, a McKinsey partner allegedly worked on a $ 2.7 million contract to help modernize the FDA’s Office of New Drugs while advising Purdue on maximizing the market potential for a new opioid, according to the report.
The report also claimed that McKinsey consultants with Purdue ties were trying to influence public health officials in the Trump administration on the subject of the opioid epidemic.
The committee wrote that some of the McKinsey consultants “formed part of what one consultant called McKinsey’s mini-‘arm ‘here at Purdue,” suggesting McKinsey’s pleasant relationship with Perdue during the period when “many McKinsey consultants worked for both the FDA and Purdue, both officially and unofficially. ” But the report did not say whether the special McKinsey consultant who used the term “mini-army” was also working on FDA projects.
The committee’s report also looked at McKinsey’s alleged lack of its potential conflicts of interest revelations to the FDA, saying the lack of disclosure potentially violated contract requirements and federal law.
McKinsey spokesman Neil Grace has previously told ABC News that Mckinsey had made necessary disclosures of conflicts of interest, saying the company’s consulting firm for pharmaceutical companies “did not create a conflict of interest” regarding its work with the FDA because it “did not advise the FDA on regulatory policy or specific pharmaceutical products, “and” given the absence of a conflict of interest, there was no requirement for any McKinsey disclosure. “
In recent weeks, lawmakers have increasingly trained their views on McKinsey and other contractors to allegedly accept public contracts while pursuing external business opportunities that could pose a conflict of interest.
Earlier this month, Senate Democrats called on the Department of Health and Human Services’ inspector general to investigate McKinsey for alleged violations of conflicts of interest related to his work with major pharmaceutical companies.
Legislators have also enacted legislation to strengthen the protection of conflicts of interest for entrepreneurs like McKinsey.