WASHINGTON – In a letter to senators, the Food and Drug Administration (FDA) said that it did
not push for answers after learning from
media
reports that McKinsey & Company did not reveal potential
conflicts of interest to the FDA while they were contracted to work for the
agency, which included working simultaneously for the FDA and opioid
manufacturers such as Purdue Pharma. The
original inquiry was sent by Sens. Maggie Hassan (D-N.H.), Chuck Grassley (R-Iowa), Sheldon White House (D-R.I.), Ed
Markey (D-Mass.), Joe Manchin (D-W.Va.) and Elizabeth Warren (D-Mass.).
To read the response
that the FDA sent to the senators, click here.
Reports show that
the FDA hired McKinsey a number of times beginning in 2008, during which the
firm appeared to be particularly involved with the FDA’s principal division for
approving certain classes of drugs, including prescription opioids. At the
same time, McKinsey was consulting for private-sector clients, such as Purdue
Pharma, that were the targets of this new regulatory process.
In
their
letter to the FDA seeking answer on McKinsey’s potential conflicts of
interest, the Senators asked the FDA when it became aware of the consulting
firm’s contracts with opioid manufacturers, and whether those disclosures
prompted a review McKinsey’s existing contracts for conflicts of interest.
ln response, the FDA said it
only became aware of McKinsey’s potential conflicts of interest after
reports
from the media earlier this year. The agency also said that because
the existing contracts between the FDA and McKinsey did not specifically
involve opioids, the agency did not feel additional oversight of McKinsey was
necessary.
“FDA became aware in early
2021 when the information was reported in the media. FDA had previous
contracts with McKinsey that covered the broad scope of the Agency’s activities
with drug products, for example, those focused on improving Agency processes or
creating visibility into supply chains,” wrote the FDA in the letter to the
Senators. “However, FDA has not consulted McKinsey about processes or review
issues associated with any specific drug product or specific product class,
including opioids. As none of FDA’s contracts were specifically related to
opioids, no additional contract reviews or outreach to McKinsey occurred.”
The FDA also told the
Senators that McKinsey was not transparent with the agency about its potential
conflicts of interest: “FDA is not aware of any disclosures made by McKinsey
vis-a-vis [Organizational Conflict of Interest] in relation to these orders.
FDA cannot speculate on why McKinsey did not consider any actual or apparent
[Organizational Conflict of Interest] to be sufficient to require reporting,”
wrote the FDA.
“We continue to see a lack of
transparency from McKinsey. By not disclosing its client lists to the FDA,
which included the big-name opioid manufacturers that helped fuel this
epidemic, the consulting firm put the health of Granite Staters and Americans
at risk,” Senator Hassan said. "We must do everything we can to
address the substance misuse crisis and ensure that the FDA is doing all it can
to prevent future conflicts of interest that could hamstring our response to
the substance misuse crisis. Big Pharma is endangering the lives of Granite
Staters, and our government must hold those responsible to full account. I will
continue to push the FDA to answer for how such a potential conflict of
interest could have occurred.”
“Transparency and
accountability are critical when federal agencies sign contracts and put
taxpayer money on the line. FDA, like every other federal agency, ought to do
the utmost to ensure contractors disclose even potential conflicts of interest
before opening up government coffers. Both McKinsey and the FDA needed to do
better here,” Senator Grassley said.
“We’ve lost hundreds of
thousands of Americans to overdose. The FDA ought to treat conflicts of
interest involving opioid makers with deadly seriousness,” said Senator
Whitehouse.
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