Despite Announcement, FDA Refuses to Change Rules Regarding Conflicts of Interests; Senator Hassan Led Call for Health and Human Services Inspector General Investigation Into the Potential Conflicts of Interest Earlier This Month
WASHINGTON – Following questioning from U.S. Senator Maggie Hassan (D-NH), a top official at the Food and Drug Administration (FDA) announced that the FDA has stopped issuing contracts to the consulting firm, McKinsey & Co., while ongoing investigations look into the failure by McKinsey to disclose potential conflicts of interest while the firm was working with the FDA on issues related to opioids at the same time it was working for opioid companies, including Purdue Pharma.
Senator Hassan has led efforts dating back to last year to hold the FDA and McKinsey responsible for potential conflicts of interest, and earlier this month the Senator led her colleagues in calling for a Health and Human Services Inspector General report on the FDA’s work with McKinsey and FDA’s contracting policies.
To watch Senator Hassan’s questioning, click here. For a transcript of her questioning, click here.
“I am still interested in wanting an answer to whether you're going to suspend contracts, current or future contracts with McKinsey, whether there is a case for referring this to DOJ,” said Senator Hassan. “And I'll continue to follow up on the issue, including with the HHS Inspector.”
“The Center for Drugs currently does not have a contract with McKinsey and across FDA. [W]e anticipate that further contracts will not be issued pending the outcome of the investigations,” said Patrizia Cavazzoni, Director for the Center for Drug Evaluation and Research for the FDA.
Senator Hassan went on to press FDA officials on how the FDA allowed these conflicts of interest to go unnoticed for years. The question followed her previous bipartisan efforts to push for answers from the FDA after learning from media reports that McKinsey did not reveal potential conflicts of interest to the FDA while they were contracted to work for the agency. Following the Senators’ outreach, the FDA responded that it had not known about McKinsey’s work with Purdue Pharma until media reports surfaced in 2021.
“The reality is that when somebody who is bragging to drug manufacturers that they know what questions to ask and have influence at the FDA, that should be of concern. And it strains credulity to think that nobody at the FDA involved with McKinsey between 2019 and 2021 had any idea that the company had major potential conflicts of interest based on news reports in major publications. How is the FDA adjusting its contracting processes going forward to ensure that it is aware of publicly reported information about apparent conflicts of interest with major companies to which it is awarding tens of millions of dollars in contracts?” Senator Hassan said.
During the hearing, the FDA three times refused any suggestion that it should change its rules regarding conflicts of interests and defended its use of self-reporting despite the failure of McKinsey to self-report its conflict of interest when consulting for both the FDA and Purdue Pharma. “As I indicated earlier, we follow contracting regulations that apply across the entire U.S. government, including other agencies. And we rely on contractors to follow those rules and to inform us of any conflicts of interest,” said Director Cavazzoni during the hearing.
Senator Hassan responded that relying on contractors to self-report conflicts of interest is not sufficient. Earlier this year, Senator joined her colleagues in introducing bipartisan legislation to require federal agencies to assess and update their procedures for determining whether contractors have a conflict of interest.