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Op-Ed | The American Prospect | October 29, 2021

Will Biden’s FDA Be Led by a Pharma Guy?

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Will Biden’s FDA Be Led by a Pharma Guy?

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Dr. Robert Califf appears to be the clearest front-runner for the (somehow) still open position of commissioner of the Food and Drug Administration. After floating his name in the press a few weeks ago, President Biden recently met with Califf in private. Such meetings tend to be the final step before a nominee is announced.

There’s just one problem: Califf is a longtime political consultant to Big Pharma and, more recently, to Big Tech. In fact, he’s so tied to those industries that he once earned the ire of a certain crucial senator from West Virginia.

Califf previously led the FDA in 2016, in the waning days of the Obama administration. His nomination at that time was actively protested across the Democratic political spectrum—both Sens. Joe Manchin and Bernie Sanders (then running for president) spearheaded the opposition, with each threatening a filibuster on the Senate floor.

Manchin was specifically concerned that Califf would not provide strong regulatory oversight to drugmakers, nor hold them specifically accountable for the effects of the opioid epidemic. He stated in 2016 that “with his long-term, significant ties to the pharmaceutical industry, Dr. Califf is not the champion the FDA needs to tackle this deadly epidemic.” Sens. Ed Markey and Richard Blumenthal echoed Manchin’s concern, emphasizing the sheer devastation created by the FDA’s irresponsible green-lighting of opioids as well as the critical need for the FDA to operate as a strong and principled regulator, not as Big Pharma’s “rubber stamp.” Califf attempted to assuage concerns by advocating for such policy changes as convening expert advisory committees before approving new potential applications for opioids that lacked “abuse-deterrent” properties. Except, as Markey noted, there are no opioids with proven “abuse-deterrence” properties. Indeed, this entire category of drug was (and still is) highly addictive. As such, Markey declared that the policy changes didn’t “go far enough,” and that the FDA’s new opioid action plan amounted to a deadly continuation of the status quo.

Sanders shared Manchin’s frustrations regarding the opioid crisis, and also emphasized his concern over ever-increasing prescription drug costs. Sanders emphasized the desperate need for an FDA head who would “work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.” Califf, Sanders stressed, was inadequate for this role because his “extensive ties to the pharmaceutical industry [gave] me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies.” From Manchin to Sanders, concerns over the nomination were ultimately rooted in Califf’s entrenched financial and professional ties to the pharmaceutical industry.

These concerns did not emerge in a vacuum. Before his nomination for commissioner, Califf was the FDA’s deputy commissioner for the Office of Medical Products and Tobacco (OMPT). There, he personally met with lobbyists and executives for the medical device industry to write proposed language for the 21st Century Cures Act. The Cures Act created a quicker path to authorizing “breakthrough” medical technologies, a designation that Public Citizen said was “too broad, and could lead to clearance of devices that aren’t ready for the market.”

As for Califf’s meeting with industry representatives, the president of the National Center for Health Research, Diana Zuckerman, called it “worse than a revolving door.” Public Citizen claimed the meeting constituted “collusion” and “violate[d] the most elementary ethical standards” for a regulator and a regulatory authority. Califf was also criticized as OMPT deputy commissioner for obfuscating his authorship of publications critical of FDA policiesOne of his articles called for loosening, and in some cases completely removing, the FDA’s informed consent requirements for certain pragmatic clinical trials. Later, while FDA commissioner, Califf faced additional criticism for controversially approving a fast-tracked drug that lacked evidence of any clinical efficacy.

Before going to work for the FDA, Califf also had served as a paid consultant for multiple Big Pharma companies. From 2006 to 2015, he was a board member and consultant to Faculty Connection, LLC, a regulatory consulting firm that boasted of its consultants’ success “in influencing the FDA.” There, Califf worked with industry giants such as Amgen, Merck, and Novartis.

Califf also had had business before the FDA personally as a doctor.

His record at the FDA also calls into question his commitment to the public. Before going to work there, Califf had led the clinical trials for Johnson & Johnson’s blood thinner Xarelto, which was approved in 2011. Senior FDA official Stephen M. Grant noted a “lack of care” in the trial’s design and execution. Several test subjects suffered strokes, which might have been avoided with a better-designed trial, Grant claimed. When presenting Xarelto to the FDA for approval, Califf himself acknowledged that the consulting fees he’d received from Johnson & Johnson constituted a potential conflict of interest, even if he donated the fees afterward. Despite this acknowledgment, Califf pushed for Xarelto’s approval, a drug medical experts said should not have been approved and which went on to cause over 300 deaths. Unsurprisingly, he received his largest-ever consultancy payment of $87,500 from Johnson & Johnson in 2012.

Over the years, Califf’s industry connections have only deepened. He is now firmly situated at the intersection of Big Pharma and Big Tech as the head of “policy” and “strategy,” i.e. lobbying, for Google Health and Google’s parent company Alphabet’s subsidiary Verily Life Sciences. He’s served both organizations as a consultant since 2017 and was tapped for his current full-time role in 2019.

Google Health is currently being sued for not sufficiently anonymizing patient health data in these analytic practices, and has faced additional concern over how it and its subsidiaries handle data privacy and data security. Further, Verily is preparing for a non-Alphabet-tied IPO. Most non-Google Alphabet companies have struggled to turn a profit, but if Verily’s former lobbying strategist is put in charge of its products’ regulation and approval, it stands to benefit tremendously.

The White House has not described Califf as a political strategist for Alphabet, instead emphasizing his role as the vice chancellor for clinical and translational research at Duke University. The research institute Califf runs at Duke, however, was majority funded by 23 Big Pharma companies, including Johnson & Johnson, Eli Lilly, and Merck. And if Big Pharma funding for one research institute wasn’t bad enough, try two: Califf was also the founding director of the Duke Clinical Research Institute, a multimillion-dollar research center mostly funded by the private sector. This is cause for concern, as Califf has a history of defending his funders even when their products put lives in jeopardy.

Califf’s Big Tech and Big Pharma connections also raise concerns about public trust in the FDA, given widespread public mistrust of Big Tech and of the pharmaceutical industryeven after the development of the COVID-19 vaccines. This may offer far-right anti-vaccination figures a troubling platform on which to reinforce dangerous vaccine conspiracies and to propagate distrust in the Biden administration. The FDA already has trust and transparency problems, and as a critical part of the country’s public-health infrastructure, it is essential that these problems be addressed and mitigated, not compounded by an ill-conceived nominee.

Notably, Califf accepted his initial consulting position at Alphabet just four months after he stepped down as FDA commissioner. With Califf now poised to return to the FDA, he is a glaring personification of the endemic revolving door at the highest levels of federal regulation. Califf’s travel between the private and public sectors, and the deepening of his ties outside of the public interest, necessarily raise the question of whose interests Califf would serve if nominated to lead the FDA.

By nominating Califf as FDA commissioner, the Biden administration would be shooting itself in the foot. Why choose someone who raised alarm bells the first time he was up for an FDA position, with dangerously close ties to the very industries he is supposed to regulate, and who was heavily scrutinized by Sen. Manchin, whose vote Biden is eager to win right now? Biden sometimes seems to love “gettin’ the boys back together” from the Obama administration, but the policy agenda that won him the presidency is not Obama’s. The long wait for an FDA commissioner should not end with a blatantly damaging pick.

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