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

STAMFORD — Senator Richard Blumenthal is asking a federal agency to investigate McKinsey & Co., the consulting firm that settled with states including Connecticut last year but is facing renewed scrutiny over alleged conflicts of interest in its work with the Food and Drug Administration and pharmaceutical companies such as OxyContin maker Purdue Pharma.

Blumenthal’s letter Thursday to the head of the Office of the Inspector General reflects widespread concern about McKinsey’s advice to the FDA and drug companies, work examined in a report this week by the Democratic majority of the FDA’s Oversight and Reform Committee House of Representatives was released.

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

“The policy violations that led to McKinsey’s conflicting advisory work with the FDA could 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 monitors the USA monitors Department of Health and Human Services programs.

“I respectfully request that the OIG conduct an investigation to understand what happened in this case, identify and hold accountable individuals or organizations responsible for the failures and ensure that such egregious conflicts of interest and violations violation of FDA guidelines will not recur.”

An OIG spokesman 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 Wednesday after the release of the congressional report, saying it protects clients’ confidential information and prevents conflicts of interest.

“In the public sector, we are also subject to the conflicts of interest requirements of our government clients and review conflicts – both actual and potential – accordingly. If potential conflicts cannot be adequately addressed, we will not get the job done,” the statement said.

“McKinsey’s work for the FDA has focused on administrative and operational issues, including organizational, business process and technology improvements. We have not advised the FDA on regulatory decisions or on specific pharmaceutical products.”

The statement did not reassure Blumenthal. Citing reports from ProPublica and the New York Times, his letter outlined his concerns about the consulting McKinsey performed for pharmaceutical companies like Purdue and Johnson & Johnson in the 2000s and 2010s related to FDA oversight and drug approval processes.

He said McKinsey’s work with these companies overlaps with his consulting for the FDA to improve the agency’s oversight of the pharmaceutical industry.

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

Among the alleged conflicts of interest, Blumenthal said McKinsey advised Purdue in responding to a 2008 FDA request that the company develop a drug safety plan for OxyContin, and also advised the FDA on an operational plan for the office that develops drug safety plans.

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

“McKinsey’s concurrent work for the FDA and for FDA-regulated companies not only raises significant concerns about the company’s failure to adequately disclose and review conflicts of interest, but also raises critical questions about the FDA’s failure to identify this major conflict of interest “, says Blumenthal called.

Blumenthal is a longtime critic of Purdue and the FDA. He believes Purdue fueled the opioid crisis with misleading OxyContin marketing and blamed the FDA for inadequate regulation and oversight of opioid companies like Stamford.

In his previous position as attorney general, prior to his election to the Senate in 2010, Blumenthal 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 report and was reviewing the findings.

“The FDA takes our role in procurement seriously, and we work to ensure the agency maintains high standards of integrity as set forth in the Federal Acquisition Regulations,” the statement said.

McKinsey’s congressional investigation, launched last November, followed a similarly focused multi-state investigation. The states’ investigation was led by an executive committee composed of 10 attorneys general, including William Tong of Connecticut.

To settle the multi-state investigation, 47 states announced in February 2021 that they would do so agree with McKinsey on a total of 573 million dollars. These funds go to programs to fight the opioid epidemic.

Connecticut was awarded a share of about $7.5 million in the settlement and 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 release tens of thousands of documents, according to Tong’s office.

“McKinsey misused her influence and expertise to charge Purdue’s deadly role in the opioid epidemic,” Tong said in a statement. “Our investigation found that McKinsey has not told the federal or state governments that they are advising Purdue and other opioid companies on how to increase opioid sales, while also advising government agencies on how to contain the opioid crisis.”

Tong added that the House Oversight Committee investigation “covers a similar area and overlaps in time with the statewide investigation. Congress rightly continues to raise questions about (the) FDA’s relationship with McKinsey and whether adequate safeguards are in place to prevent future conflict and abuse.”

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

pschott@stamfordadvocate.com; Twitter: @paulschott

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