Some U.S. senators are questioning the Food and Drug Administration (FDA) about conflicts of interest in working with a consulting firm that helped companies sell opioids during the nation’s opioid epidemic, the Associated Press reported.
Democrat Maggie Hassan of New Hampshire and Republican Chuck Grassley of Iowa, among others, sent a letter Monday to the FDA asking about any conflicts of interest in working with McKinsey and Co. The letter points out how the FDA has provided McKinsey with over $140 million since hiring the firm multiple times since 2008.
McKinsey “worked for a wide range of actors in the opioid industry, including many of the companies that played a pivotal role in fueling the opioid epidemic that our country now faces,” the letter stated.
The firm worked with the FDA’s Center for Drug Evaluation and Research that is responsible for giving approval to prescription opioids and other substances, according to the letter. The letter follows lawsuit settlements this year in which McKinsey agreed to pay nearly $600 million to almost every state and five U.S. territories over its involvement with drug makers in the sale of prescription opioids.
For more reporting from the Associated Press, see below.
Neither the FDA nor McKinsey immediately responded to requests from AP seeking comment.
Opioids, which also include illegal substances like heroin, have been linked to almost a half million deaths in the U.S. since 2000, a problem that has deepened during the COVID-19 pandemic.
While working with the FDA, McKinsey also advised opioid manufacturers on avoiding oversight from the regulator, according to the letter. The consultant advised Purdue Pharma on how to soften an FDA drug safety program that required companies to communicate risks to patients, care providers and pharmacists.
The senators noted that the final program announced in 2012, “was largely devoid of the restrictions the FDA had initially proposed.”
The senators asked the FDA to answer several questions and provide documents by September 15. They want to know how the agency checks for conflicts of interest and what its current relationship is with McKinsey.
They also asked what disclosures McKinsey made to the agency about potential conflicts and when the FDA became aware that McKinsey’s clients included “several major opioid distributors and retailers.”
Four Democratic senators joined Hassan and Grassley in signing the letter. They are West Virginia’s Joe Manchin, Rhode Island’s Sheldon Whitehouse and Massachusetts Sens. Elizabeth Warren and Edward Markey.