Senate Committee Advances Senator Hassan’s Bipartisan Measures to Prevent Conflicts of Interest in FDA Contracting

WASHINGTON – The Senate Health, Education, Labor, and Pensions (HELP) today advanced bipartisan measures from Senator Maggie Hassan to help prevent conflicts of interests with contractors at Food and Drug Administration (FDA). This effort builds on Senator Hassan’s work to address the potential conflicts of interest that arose when the consulting firm McKinsey was working simultaneously for both the federal government and opioid manufacturers that fueled the substance misuse crisis. 

“The dangers of conflicts of interest in government contracting are exemplified by McKinsey’s work for the FDA as opioid manufacturers fueled the opioid epidemic,” said Senator Hassan. “The amendments that moved forward today would help ensure that companies that enter into a contract with the government are acting in the best interest of the American people. I’ll continue working with my colleagues to get this effort across the finish line and help stop conflicts of interest.”

Reports have highlighted the need to prevent conflicts of interest within companies that are awarded federal contracts. For example, McKinsey, a management consulting corporation often hired by the federal government, was paid more than $140 million since 2008 by the FDA to help support the agency’s oversight of pharmaceutical companies. McKinsey failed to disclose to the FDA that it was also consulting for several opioid manufacturers on how these companies could effectively market their products.

Senator Hassan’s bipartisan amendments that passed today would:

• Ensure that contractors working for the FDA continuously disclose their conflicts of interest over the life of their contract with the agency, and not just at the time of signing.
• Bar individual employees of consulting firms from simultaneously working for the FDA and companies that the agency regulates.
• Require that the FDA publish information on any organizational conflict of interest waivers it grants to contractors.

Senator Hassan has led efforts dating back to last year to hold McKinsey responsible for potential conflicts of interest when contracting with the federal government and fueling the substance misuse crisis. Last month, the Senate Homeland Security & Governmental Affairs Committee advanced a bipartisan bill from Senators Hassan, Chuck Grassley (R-IA), Gary Peters (D-MI), and Joni Ernst (R-IA) to help prevent potential conflicts of interest between taxpayer-funded projects and government contractors’ other business opportunities. During the Senator’s questioning at a Senate hearing in April, a top FDA official announced that the FDA has stopped issuing contracts to McKinsey pending ongoing investigations into the firm’s potential conflicts of interest. Prior to that, the Senator led her colleagues in calling for Health and Human Services Inspector General to investigate the FDA’s work with McKinsey and the FDA’s contracting policies.

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