McKinsey & Co. Under Fire for Allegedly Advising Purdue and FDA Concurrently

McKinsey & Co_Business Insider

McKinsey & Company, a consulting firm that covers multiple industries including healthcare and life sciences, is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration. The New York Times reviewed thousands of internal company documents finding that the space for conflicts of interest to run rampant was significant.

The Times stated that since 2010, at least 22 McKinsey consultants worked for both Purdue Pharma, a company known for playing a role in the opioid epidemic with its drug OxyContin, and the FDA. Of major ethical concern is the possibility that McKinsey consultants played a role in shaping documents submitted to the FDA from Purdue, making them more appealing to FDA members who are in charge of determining approval for drugs. Purdue has been in the business of restructuring its assets and pipeline as the opioid epidemic continued to expand, apparently utilizing McKinsey as a gateway for consulting advice on its forward-thinking plans.

On April 13, the House Committee on Oversight and Reform released an interim staff report that contained preliminary findings from the Committee’s investigation into McKinsey’s consulting work during the opioid epidemic. The investigation confirmed that McKinsey consultants frequently worked on FDA contracts while also working for opioid manufacturers and did not disclose conflicts of interest to the FDA. Additionally, the company was found to have used its government consulting work, connections and influence to solicit more business from opioid manufacturers and allegedly attempted to influence government officials to advance the interests of opioid clients.

“Behind the scenes McKinsey consultants leveraged their federal connections to secure even more private sector business and tried to influence key public health officials on behalf of clients like Purdue Pharma," said Committee Chairwoman Rep. Carolyn Maloney in a statement. "McKinsey’s conduct is even more egregious considering its central role in driving a public health crisis that has killed half a million Americans and continues to claim tens of thousands of lives every year. The American public will soon learn even more about McKinsey’s role in the opioid epidemic thanks to the hard work of state Attorneys General and their landmark $573 million settlement."

McKinsey told the Times that its consultants are forbidden to share confidential information or discuss their work with clients that have competing interests, vehemently denying that any of its consultants have specifically advised the FDA on regulatory decisions or specific pharmaceutical products. However, McKinsey produced no evidence to the Committee that it ever disclosed its extensive work for opioid manufacturers to the FDA, potentially violating contract requirements and federal law. Additionally, as early as 2017, McKinsey consultants apparently discussed deleting documents related to their work for Purdue.

According to the Times, McKinsey is a repeat offender when it comes to taking on clients in the same industries and working with governments in other countries including those in Europe and Asia. Reportedly, the consultant company touted its inside connection to the FDA in pitches to biopharmaceutical clients.

The FDA has also denied any nefarious connections between the agency and McKinsey, stating to the Times that its contracts with McKinsey were related to internal and process issues and did not include work on specific drug products, including opioids. With investigations ongoing, it will remain to be seen just how proliferative the connection between McKinsey and biopharma is and what the potential ramifications are.

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