House Oversight Committee digs in on McKinsey's conflicting ties with FDA, opioids, and blocking Humira competitors
McKinsey is under fire again, this time from the House Oversight Committee, which is digging into the consulting firm’s close ties to the FDA while working simultaneously to promote opioids and find ways to stall competition for AbbVie’s blockbuster rheumatoid arthritis drug Humira.
Since 2008, FDA has paid McKinsey over $140 million for various tasks relating to opioids, drug safety, and drug approvals, as well as a “track and trace” system for drugs, monitoring programs to assess drug safety, and ways to streamline the drug approval process.
But Purdue Pharma’s records show, according to the committee, that at the same time McKinsey was advising FDA, including offices responsible for opioid programs, the company was also advising Purdue on how to lobby the FDA.
“For instance, in 2008, FDA proposed new safety rules for OxyContin under the agency’s Risk Evaluation and Mitigation Strategies (REMS) program—including a requirement that the painkiller could be prescribed only by specially trained pharmacies or healthcare practitioners,” the committee says. Purdue hired McKinsey, which successfully rebuffed stronger REMS safety measures until 2012, despite the objections of an independent panel of experts who recommended more rigorous training for prescribers and the reduction of industry influence in the safety measures.
“It is not known to what extent McKinsey consulted for the opioid industry during this same period, how much McKinsey received in compensation from opioid-related entities, or whether FDA consulted with McKinsey on the decision to reject stronger safety rules,” the committee’s letter to McKinsey on Friday said.
Sen. Maggie Hassan (D-NH), whose state has been hit hard by the opioid crisis, directly questioned FDA acting commissioner Janet Woodcock on Thursday about how the FDA didn’t know until recently about its conflicting work with McKinsey, which was also consulting for opioids manufacturers while working on the FDA’s track-and-trace system. But Woodcock said that she did know, and she said she didn’t think there was anything improper going on.
“Well, speaking for myself, I was aware, at that time that McKinsey was only doing consulting work of an administrative nature for the FDA,” Woodcock said. “Nothing to do with any product or standard or anything like that.”
But Hassan questioned her again on McKinsey’s track-and-trace work and McKinsey’s public apology last year. She also questioned why the agency said it’s not reaching out to McKinsey for future work, if nothing from their past was irregular. Hassan said she thought this was a major conflict of interest that could’ve fueled the opioid epidemic.
Woodcock has taken a lot of heat over the opioid approvals under her watch as CDER director, and it may have contributed to her not being nominated as permanent commissioner (although President Biden has yet to make his nomination).
Another Dem, Sen. Joe Manchin of West Virginia, previously wrote to President Joe Biden, advising him not to name Woodcock as permanent FDA commissioner because of the decisions she made around opioids in the past. “By overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 – and Dr. Woodcock has been there for all of it. Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic,” Manchin wrote.
In addition to McKinsey’s opioids work, according to documents obtained by the House committee in its drug pricing investigation, McKinsey in August 2010 also advised AbbVie on ways to block competition for its blockbuster drug, Humira, which will remain without biosimilar competition until 2023. McKinsey was working closely with the FDA’s generic drug office at the time, the committee said.
The committee is now requesting that McKinsey provide by Nov. 19 a series of documents to understand the full scope of its monitoring failures, conflicts of interest, and consulting.
Among those documents will be a detailed description of any matters McKinsey has worked on for FDA since 2008 involving opioids, generic drugs, biosimilar drugs, drug distribution, drug approvals, the drug approval process, track-and-trace systems, REMS, or drug safety programs, including the dates, subject matter, work performed, and amount FDA paid McKinsey for each project.
In addition, the committee is seeking all presentations, memoranda, reports, or other work product prepared for FDA between 2005 and 2021. It also requested a list of all McKinsey consultants or employees who consulted or otherwise worked on projects for FDA between 2005 and 2021 and also worked on projects for any opioid- or pharmaceutical-related company at any time during this period, including but not limited to AbbVie, Amgen, Celgene, Sanofi, Purdue, Endo, Mallinckrodt, Janssen, Teva, Actavis, Amerisource Bergen, McKesson, Cardinal Health, CVS, and Walmart.