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FDA commish nominee's financial disclosures reveal a vast web of industry ties. Will they matter?

Zachary Brennan
Senior Editor

President Biden’s nominee to run the FDA was hit with some tepid criticism back in 2016 for being too cozy with the biopharma industry because some of the trials he ran had industry sponsors and some of the funding he took was from industry.

Nevertheless, Rob Califf sailed through his confirmation then, and his successor Scott Gottlieb showed that even closer ties to industry shouldn’t stop an effective leader from being FDA commissioner.

But according to financial disclosures released this week, Califf’s ties to biopharma have only gotten cozier since 2016, raising fresh questions of whether more than the usual gang of anti-COI Democrats (Sens. Ed Markey, Richard Blumenthal and Joe Manchin) will try to block his nomination.


Any other Dems looking to attack Califf will have plenty of ammo to work with. In addition to his $2.7 million salary and bonus from the life sciences company Verily, Califf also owns between $1 million and $5 million of the company that he’ll have to cash out prior to re-joining FDA.

Upon confirmation, he’ll also have to resign from 14 different positions he holds, including seats on 7 different companies’ board of directors and advisory teams, as well as university posts at Duke, Stanford, Vanderbilt, and the University of Colorado.

In the case of Centessa Pharmaceuticals, he’ll have to resign from the board and cash out $1 million to $5 million in unvested stock options. He’ll also have to resign from his position on the board of Cytokinetics, where he’ll have to divest another $1 million or more, and he’ll have to resign his position on the advisory team of Amyriad Therapeutics, where he said he was about to receive unvested stock options.

He’ll also have to resign from the advisory board of Basking Biosciences, where he was on the clinical advisory board; Clinetic, where he was a board member; Bitterroot Bio, where he was an unpaid consultant; and his unpaid position on an advisory team at Medicxi Ventures, a top investment firm focused on the life sciences.

In addition, Califf will have to sell off a lot of stock he purchased in biopharma companies, including between $250,001-$500,000 in Bristol Myers Squibb, another $250,001-$500,000 in Amgen, and $100,001-$250,000 in Gilead stock. He also disclosed more than $5,000 in compensation from Boehringer Ingelheim for lectures, discussion groups, and consulting services.

All told, Califf could be cashing out from positions and stock worth upwards of $10 million from various life science companies before taking over as the head of the FDA.

Aaron Kesselheim, a professor of medicine at Harvard who famously resigned from an FDA adcomm after the agency approved Biogen’s controversial Alzheimer’s drug, told Endpoints:

Dr. Califf is an internationally respected expert in clinical trials and their use in generating the strongest possible evidence, so I would expect that he would have built connections with pharmaceutical companies throughout his career in this context. Relationships like those are best if they’re arms-length. It will be very important for Congress to dig into what you’re reporting and ensure that any ties Dr. Califf has can be appropriately managed if he does become the FDA Commissioner, since it is paramount that the FDA pursue public health goals first and foremost and that we maintain public trust in an independent FDA free from undue industry influence.

But it remains unclear to what extent his industry experience and divestitures will impact his confirmation process. After more than a year of serving under an acting commissioner, the FDA is currently desperate for a Senate-confirmed leader who can provide a longer-term strategy and rebuild a workforce hit hard by the pandemic and political meddling from the last administration.

But Califf’s nomination doesn’t steer the agency away from its lingering reputation of being a revolving door for the biopharma industry. As top former FDA leaders like Gottlieb (Pfizer), Amy Abernethy (who joined Califf at Verily), Lowell Schiller (Aetion), Steve Hahn (Flagship Pioneering), and others continue to plunge into industry, the regulator and the regulated industry are slowly becoming one in the same. Those ties will only get closer as industry continues to provide the vast majority of FDA funding via its user fee deals.

AUTHOR
Zachary Brennan
Senior Editor
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