‘Egregious conflicts of interest’

Blumenthal seeks probe of consulting firm’s work with Purdue, FDA

STAMFORD — Sen. Richard Blumenthal, D-Conn., is calling for a federal agency to investigate McKinsey & Co., the consulting firm that last year settled with states including Connecticut but faces renewed scrutiny of alleged conflicts of interests in its work with the Food and Drug Administration and pharmaceutical companies including OxyContin maker Purdue Pharma.

Blumenthal’s letter Thursday to the head of the Office of Inspector General reflects the widespread concerns about McKinsey’s consulting for the FDA and pharmaceutical companies, work that was examined in a report released this week by the House Committee on Oversight and Reform’s Democratic majority.

Among its key findings, the report said that the committee’s investigation of McKinsey found 37 FDA contracts that were staffed by at least one McKinsey consultant who simultaneously or previously worked for Stamford-based Purdue.

“The breach in policy that resulted in McKinsey’s conflicted consulting work at the FDA may have had a significant impact on Americans — particularly those who have suffered from opioid abuse,” Blumenthal said in the letter to Inspector General Christi Grimm, whose agency oversees the U.S. Department of Health and Human Services’ programs.

“I respectfully urge the OIG to conduct an investigation to understand what happened in this case, identify and hold accountable individuals or entities responsible for the failures and ensure that such egregious conflicts of interest and breaches of FDA policy do not occur again.”

An OIG spoksperson told Hearst Connecticut Media on Friday that “our agency has received the letter and is reviewing it for appropriate action.”

Messages left for Purdue were not returned.

McKinsey released a statement on Wednesday following the release of the Congressional report in which it said that it protects clients’ confidential information and guards against conflicts of interest.

“In the public sector, we are also subject to our government clients’ conflict of interest requirements, and we review con

flicts — both actual and potential — accordingly. If potential conflicts cannot be appropriately addressed, we will not do the work,” the statement said.

“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.”

The statement did not reassure Blumenthal. Citing reporting from ProPublica and The New York Times, his letter outlined his misgivings about consulting that McKinsey did in the 2000s and 2010s for pharmaceutical companies such as Purdue and Johnson & Johnson related to FDA oversight and drug-approval processes.

He said that McKinsey's work with those companies overlapped with its consulting for the FDA on how to improve the agency's oversight of the pharmaceutical industry.

“These client interests are in direct conflict and yet McKinsey not only continued both representations, but actually used its work for the FDA as leverage to secure pharmaceutical industry work, stressing its relationship with the FDA in an email to Purdue in 2014,” Blumenthal said.

Among the alleged conflicts of interest, Blumenthal said McKinsey advised Purdue on how to respond to a 2008 request from the FDA that the company develop a drug safety plan for OxyContin, while also advising the FDA on an operating plan for the office developing drug safety plans.

In 2012, the FDA released an opioid safety plan that had been “significantly watered down compared to prior drafts,” he said.

“McKinsey's simultaneous work for the FDA and for FDA-regulated entities not only raises significant concerns about the company's failure to adequately disclose and review conflicts of interest, but also creates critical questions regarding the FDA's failure to identify this major conflict of interest,” Blumenthal said.

Blumenthal is a longstanding critic of Purdue and the FDA, which he believes have, respectively, stoked the opioid crisis with deceptive OxyContin marketing and inadequate regulation and oversight of opioid makers such as Purdue.

In his previous position as state attorney general, before his 2010 election to the Senate, he sued Purdue and the FDA over matters unrelated to their work with McKinsey.

The FDA said in a statement that it was aware of the House Oversight Committee's report and was reviewing the findings. It added that “the FDA takes our role awarding contracts seriously and we work to ensure the agency maintains high standards of integrity as set forth in the Federal Acquisition Regulations.”

The Congressional inquiry of McKinsey, which was launched last November, followed a similarly focused multistate investigation. The states' probe was led by an executive committee comprising 10 state attorneys general, including Connecticut's William Tong.

To resolve the multistate investigation, 47 states announced in February 2021 that they would settle with McKinsey for a total of $573 million. Those funds will go toward programs to tackle the opioid epidemic.

Connecticut was allocated an approximately $7.5 million share of the settlement, and it has already received about $6.5 million.

The settlement also requires McKinsey to stop advising companies on narcotics sales, adhere to ethics and disclosure standards, and make public tens of thousands of documents, according to Tong's office.

“McKinsey abused their influence and expertise to turbocharge Purdue's deadly role in the opioid epidemic,” Tong said in a statement. “Our investigation found McKinsey never disclosed to either the federal or state government that they were advising Purdue and other opioid companies on how to increase opioid sales while simultaneously advising governmental entities on how to abate the opioid crisis.”

Tongs added that the House Oversight Committee's investigation “covers similar ground and overlaps in time with the multistate investigation. Congress is right to continue to ask questions regarding (the) FDA's relationship with McKinsey and whether there are adequate protections in place to prevent future conflicts and abuse.”

Separately, Connecticut announced last month that it would join a $6 billion settlement with Purdue and the Sackler family members who own the company to resolve lawsuits alleging that the company fueled the opioid crisis with fraudulent OxyContin marketing.

Blumenthal