AACR Backs Biden’s Nominee for FDA Commissioner

David A. Tuveson, MD, PhD, FAACR

The American Association for Cancer Research (AACR) issued a statement today congratulating Robert Califf, MD, on his nomination to be the next FDA commissioner. The association “strongly supports” his return to the agency.¹

Califf, a renowned cardiologist and leading expert on clinical trials, previously served as the FDA’s deputy commissioner for Medical Products and Tobacco from February 2015 until February 2016, when he was appointed FDA commissioner. Califf held that position until 2017.

“While the scientific opportunities that exist today to develop more effective cancer treatments have never been greater, we also recognize that the science is increasingly complex, especially when factoring in the rapidly expanding effectiveness of molecularly targeted therapies and combination therapies,” David A. Tuveson, MD, PhD, FAACR, AACR president and director of the Cold Spring Harbor Laboratory Cancer Center in New York, said in a statement. “Therefore, this extraordinary time of promise requires an experienced and visionary leader at the FDA to ensure that the necessary regulatory framework is in place to approve innovative therapies that are both safe and effective, and Dr Califf is the right person for this extremely important position. We encourage members of the Senate to move expeditiously to confirm his appointment.”

In a statement released November 12 announcing the nomination, President Joe Biden called Califf “one of the most experienced clinical trialists in the country.” The president added that Califf has “expertise and experience” to lead the FDA through the COVID-19 pandemic.²

Califf is currently a senior adviser for Google Health, and head of clinical policy for Verily Life Sciences, a biotechnology startup spun off from Google’s parent company, Alphabet.

The AACR worked closely with Califf during his previous stint at the FDA. In January 2016, 15 prominent members met with him and other senior officials for a day-long meeting to discuss the agency’s thinking on laboratory developed tests, companion diagnostics for cancer therapies, and the regulation of next-generation sequencing-based tests.

“Dr. Califf’s appointment recognizes the vital importance of scientific innovation that is especially needed during this challenging period of the pandemic,” AACR CEO Margaret Foti, PhD, MD (hc), said in a statement. “We are excited about working with Dr. Califf again, along with the talented and innovative individuals at the FDA, to ensure the rapid approval of safe and effective treatments for patients with cancer.”

Prior to his tenure at the FDA, Califf spent 30 years at Duke University School of Medicine in a variety of roles, including the Donald F. Fortin, MD, Professor of Cardiology, and vice chancellor for Health Data Science. He also served as director of the Duke Translational Medicine Institute, and as founding director of the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Califf has led major initiatives aimed at improving methods and infrastructure for clinical research, such as the Clinical Trials Transformation Initiative, a public-private partnership co-founded by the FDA and Duke University. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center, and as co-principal investigator of the Patient Centered Outcomes Research Institute Network.

If confirmed by the Senate, Califf will lead an agency that is responsible for more than $2.8 trillion worth of food, medical products, and tobacco. The FDA regulates products accounting for about 20 cents of every dollar spent by consumers in the United States, according to the agency.³

The AACR also recognized the efforts of Janet Woodcock, MD, who served as FDA Acting Commissioner for the past 10 months. “The entire cancer research and patient care community also owes her a tremendous amount of gratitude for her extraordinary leadership and for her vision and steadfast dedication during her impressive 30-plus year career at the FDA leading to improvements in the health of all Americans.”

References

1. AACR applauds nomination of Robert Califf, MD, as FDA commissioner. News release. American Association for Cancer Research. November 16, 2021. Accessed November 16, 2021. https://bit.ly/30ABhvx
2. The White House. Statement from President Joe Biden announcing his intention to nominate Dr Robert Califf for commissioner of food and drugs. News release. The White House. November 12, 2021. Accessed November 16, 2021. https://bit.ly/30qXZpt
3. Fact sheet: FDA at a glance. Food and Drug Administration. November 2020. Accessed November 16, 2021. https://bit.ly/3DuuGRK