InsideHealthPolicy - By Tapping Califf, Biden Seeks Experienced FDA Chief At Critical Time

Beth Wang | November 12, 2021

President Joe Biden’s nomination of former FDA chief Robert Califf to once again lead the agency aims to bring a familiar face back to FDA at a critical juncture as the agency gears up for a post-COVID-19 world that is expected to include greater reliance on digital technologies and a rethinking of longstanding clinical trial policies.

Since his previous run as FDA chief, Califf, who is currently head of clinical policy and strategy for Verily and Google Health, has called for FDA to be an independent agency, pushed for changes to the clinical trial enterprise, and highlighted the benefits of using digital health technologies to enhance trial data.

Major FDA reforms are around the corner as Congress readies the next round of Cures legislation and user fee bills. FDA also is charting new regulatory turf on tobacco, cannabis, nonprescription drugs, digital health and its role with payers like CMS.

If confirmed, Califf would return to the agency not only as a former FDA chief -- he led the agency under the Obama administration from February 2016 to January 2017 -- but also with experience as FDA deputy commissioner for medical products and tobacco.

Before joining FDA, Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.

Califf’s nomination comes just days before current acting FDA chief Janet Woodcock’s tenure comes to a close. Woodcock has served in the acting role since Biden took office in January.

The Federal Vacancies Reform Act only allows someone to serve as acting chief for 210 days before being replaced. However, if someone else is nominated for the position before the 210-day limit, the acting officer can stay longer while the nomination is being considered, according to the Congressional Research Service. Since Califf’s nomination comes ahead of the 210-day limit, Woodcock can stay on as acting chief until Califf is confirmed by the Senate.

Woodcock reportedly was being eyed as a top contender for the permanent role. However, several key lawmakers, including West Virginia Democrat Sen. Joe Manchin, argued she is too industry friendly.

But Califf also is facing opposition from Manchin, who is key to passing the Biden administration’s broad reconciliation package. House Democrats are expected to vote on the historic reconciliation package next week, but it’s unclear how the package will fare in the Senate, as Manchin, who opposes some of the bill’s provisions, remains uncommitted.

In a Friday (Nov. 12) statement, Manchin said he opposed Califf’s nomination in 2016 and cannot support it now.

The lawmaker said Califf’s nomination makes no sense as the opioid epidemic continues to wreak havoc on families across the United States.

Manchin said the nomination is an insult to the families and individuals who have had their lives changed as a result of opioid addiction.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide o the opioid epidemic. Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Manchin wrote.

Back in 2016, Manchin and Sen. Edward Markey (D-MA) cited Califf’s past ties to industry as one reason they didn’t think he would be effective in changing the culture at FDA.They highlighted ways FDA could better address the prescription painkiller abuse epidemic and outlined steps they were considering to curb the larger opioid addiction problem.

Senate Budget Committee Chair Bernie Sanders (I-VT) also opposed Califf’s nomination in 2016, citing his “close ties to the pharmaceutical industry and lack of commitment to lowering drug prices.” Sanders said at the time that FDA must change the way it approaches addiction.

Public Citizen also has come out against Califf’s nomination, pointing to his “long history of extensive financial ties” to the drug industry, most significantly through pharmaceutical industry funding to the Duke Clinical Research Institute, which he founded in 1996.

Prior to his last stint as FDA commissioner, Califf received personal payments from at least 19 major pharmaceutical companies, including Amgen, GlaxoSmithKline, Johnson & Johnson, Novartis and Pfizer, Michael Carome, director of Public Citizen’s Health Research Group, said in a press statement Friday.

Additionally, when he left FDA in 2016, Califf went on to receive consulting fees totaling tens of thousands of dollars from AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Eli Lilly, Merck Sharp & Dohme and Sanofi. And in February 2018, he was appointed to the board of directors of biopharmaceutical company Cytokinetics, according to Carome.

“Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries,” Carome said. “The Senate therefore must reject Califf’s nomination and demand that Biden nominate an individual who has been dedicated to advancing public health -- one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries.”

The Environmental Working Group, however, applauded Califf’s nomination. If confirmed by the Senate, EWG wants Califf to immediately ban the use of per- and polyfluoroalkyl substances (PFAS) in food packaging and cosmetics; set “tough standards” for toxic metals in baby food; quickly ban the use of formaldehyde in hair-straightening products; require companies to test their talc-based cosmetics for asbestos; and expedite the agency’s review of chemicals, like oxybenzone, in sunscreens.

“During his previous tenure as the head of FDA, Dr. Califf demonstrated his understanding of the risks that toxic chemicals in personal products, sunscreens and food packaging pose to our health,” EWG Senior Vice President for Government Affairs Scott Faber said on Friday.

Friends of Cancer Research said it “strongly supports” Califf’s nomination and called for a quick confirmation process.

The organization said the nomination sends a clear signal to career FDA scientists that Biden respects the agency and its work, and lets the American public know that FDA will continue to be patient-centered and driven by science.

Califf’s experience will enhance the agency’s commitment to fostering science-driven solutions and innovations, Friends of Cancer Research said.

“Dr. Califf’s commitment to science, dedication to research, and fierce advocacy for patients unequivocally makes him the right leader at this critical time,” Friends of Cancer Research Chair and Founder Ellen Sigal said Friday. “There are few individuals better positioned to continue to build confidence in the Agency, ensure science-based regulatory standards, and build a strong foundation for the future.”

Friends of Cancer Research also applauded Woodcock’s leadership over the past year, noting that she has led the agency during one of the most trying and important public health moments in U.S. history.

Last month, Research!America, which advocates for increased funding for the National Institutes of Health, FDA and others, said it strongly supported Califf’s nomination back in 2015 and would be proud to support him again.

“We urge the Administration to grant confirmation as expeditiously as possible,” the organization wrote in an Oct. 14 email. -- Beth Wang (bwang@iwpnews.com)

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