Lawmakers review McKinsey’s opioids, FDA advisory work – US News & World Report | Region & Cash

By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) – House Democrats vowed to continue investigating consulting giant McKinsey’s work with opioid drug makers after a hearing on Wednesday detailed how the company had advised companies pushing painkillers, as well as U.S. public health officials.

The hearing before a House committee is part of an ongoing investigation into McKinsey’s role in the US opioid crisis, which has been linked to over 500,000 overdose deaths from both prescription painkillers and illicit drugs like fentanyl.

McKinsey’s top executive questioned some of the committee’s findings, but said the company has overhauled its business processes and is no longer working with opioid makers, including OxyContin maker Purdue Pharma.

“I have apologized for our work for Purdue and other opioid companies, and we fully recognize that it has fallen short of our standards,” Bob Sternfels told the House Oversight and Reform Committee. He said the company will continue to work with investigators.

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Last year, the consulting firm agreed to pay $600 million to settle legal disputes over its work advising opioid manufacturers, though it admitted no wrongdoing.

Lawmakers spent three hours questioning Sternfels about revelations that his company allowed consultants from Purdue Pharma to simultaneously advise the Food and Drug Administration, the agency tasked with overseeing drug safety.

“McKinsey advised both the fox and the chicken coop — and was paid for by both,” said Vice Chair Carolyn Maloney, DN.Y. “McKinsey clearly shouldn’t be setting a strategy for both drug companies and the FDA.”

A preliminary report from the committee found 22 McKinsey consultants who had worked for both the FDA and an opioid manufacturer over a decade. The overlapping work included McKinsey employees advising the FDA on overhauling its drug safety division, according to the committee’s review of thousands of company documents.

Meanwhile, McKinsey consultants recommended “cash prizes” and “unmatched recognition” for OxyContin’s top salespeople to boost Purdue’s revenues, according to a 2013 strategy presentation released Wednesday.

Lawmakers heard conflicting reports about whether McKinsey’s work helped Purdue avoid stricter FDA regulations.

Massachusetts Attorney General Maura Healey testified remotely that her state’s own investigation into McKinsey uncovered emails recommending Purdue to “team up” with other drugmakers in 2009 to “oppose the harsh treatment.” defended by the FDA”.

Sternfeld said McKinsey did not share any FDA documents or information with Purdue, and the claims about the information sharing were inaccurate.

He also testified that McKinsey is open with the FDA about its pharmaceutical advisory work.

“We’ve made it very clear that we’re working with both industry and opioids in particular,” Sternfeld said. FDA officials have previously stated that they were aware of McKinsey’s pharmaceutical advice.

Maloney and other Democrats have repeatedly suggested that McKinsey’s work may have violated federal contract rules on disclosure of potential conflicts of interest.

On Wednesday, Maloney introduced legislation that would strengthen requirements for contractors to disclose potential conflicts. A bipartisan group of senators has previously introduced similar legislation in their chamber.

Committee Republicans spent most of their allotted time undermining the relevance of the hearing, noting that the vast majority of opioid overdoses are now caused by fentanyl and heroin, not prescription drugs. They called for tighter border security, noting that almost all illicit opioids enter the US through the southern border.

“We have a new opioid crisis, folks, and it’s not coming from the big drug companies in the United States — it’s coming from the drug cartels that operate sites in Mexico,” said Rep. Byron Donalds, R-Florida.

House Democrats highlighted several examples in which McKinsey touted its ties to the FDA when soliciting consultative deals from drugmakers. According to the report, the company also provided advice to members of the Trump administration on how to deal with the opioid epidemic. It is unclear if the information had any impact on federal policy.

McKinsey has been the leading management consulting firm for decades, advising on strategy and operations for many of the world’s largest companies. The company has also branched out into government consulting, winning nearly $1 billion in federal contracts.

The oversight committee reviewed McKinsey’s work on three dozen FDA contracts worth more than $65 million, spanning from 2008 to 2021.

At a separate Senate hearing on Tuesday, the head of the FDA’s drug center told lawmakers McKinsey’s work was about “organizational design and no involvement in product regulation” while Congress probes the company.

The House report did not conclude that McKinsey’s FDA advice resulted in easier regulation of OxyContin or other opioids.

For years, the FDA has tried to discourage doctors from overprescribing the drugs, mostly by adding stricter warnings to their labeling. Prescriptions have declined since their peak in 2012, but primarily due to new prescription limits imposed by state and local governments, insurers, and hospital systems.

AP writer Geoff Mulvihill, from Cherry Hill, NJ, contributed to this story

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