Robert Califf Back as FDA Head

The cardiologist and clinical trial specialist who briefly served as FDA commissioner in the Obama administration—during which time he oversaw the creation of the Oncology Center of Excellence (OCE), extended the agency's oversight of tobacco products, and pushed to expand the use of real-world evidence in regulatory decision-making—will take the helm once more.

By a vote of 50–46, the U.S. Senate confirmed Robert Califf, MD, as FDA commissioner on February 15.

The tally was close due to controversy over abortion politics, the FDA's handling of the opioid epidemic, and Califf's prior work for the pharmaceutical industry. But those who know Califf applauded the confirmation.

“It's a very strong choice,” says Gideon Blumenthal, MD, former deputy director of the OCE and now vice president for oncology global regulatory affairs at Merck. “I think he will continue to be very supportive of the OCE's efforts and in pushing forward novel regulatory science pathways.”

Califf formally launched the OCE in January 2017, on his last full day at the FDA. Authorized by the 21st Century Cures Act as part of the National Cancer Moonshot Initiative, the OCE was designed to streamline the development of cancer therapies by consolidating clinical reviews across the FDA's various branches.

The center played a critical role in the first approval of a tumor agnostic, biomarker-defined cancer treatment; it oversaw clinical reviews for the first chimeric antigen receptor T-cell therapies and the first comprehensive genomic profiling test approved as a companion diagnostic for all solid tumors; and its staff pushed to use observational patient registry data and electronic health records to expand the label indication for a targeted drug combination (Nat Rev Clin Oncol 2018;15:127–8).

The OCE also rolled out innovative regulatory instruments, including the Real-Time Oncology Review program, which allows for early submission of top-line clinical trial results and datasets for agency review ahead of a full application, and Project Orbis, through which multiple countries simultaneously review oncology drug applications and make regulatory decisions.

As commissioner, Califf will likely be tasked with broadening the scope of such programs. A bipartisan “Cures 2.0” bill introduced in the U.S. House in November would, if passed, empower the FDA to increase its use of real-world data, explore new regulatory frameworks, and create more centers of excellence modeled after the OCE.

Before his 11-month stint as FDA chief in 2016–2017, Califf spent a year as the agency's deputy commissioner for medical products and tobacco after a decades-long career at Duke University Medical Center in Durham, NC, where he helped design numerous trials with large drug makers. Since leaving government, Califf worked as an adviser to Verily, a Google-backed life sciences venture, and returned to Duke to lead the university's center for health data science.

Although Califf has been criticized for close ties to the pharmaceutical industry, some experts and government insiders see that more as an asset than a liability.

“He understands the dynamics of clinical trials, inside and outside, more than most FDA commissioners have,” says Greg Simon, JD, former executive director of the White House Cancer Moonshot Task Force.

Califf returns to an agency under strain. The FDA's 18,000 employees are facing burnout from the heavy coronavirus pandemic workload, while the agency's reputation for scientific independence has suffered from recent controversies, such as its response to COVID-19 and the June 2021 approval of an Alzheimer drug with questionable clinical benefit.

However, Califf's on-the-job experience and insider FDA knowledge should help him quickly address these issues. “I think he will be a source of morale boosting for the staff,” Blumenthal says. “It will be an advantage that he's been there before—although it's a more challenging environment right now.” –Elie Dolgin

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