As Prescribed


The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet Woodcock.

Dr. Califf—a cardiologist at Duke University School of Medicine—is not a newcomer to FDA. In February 2015, under President Obama’s second administration, he assumed the role of deputy commissioner for medical products and tobacco, and he was later appointed as commissioner, serving from February 2016 to January 2017.

While at FDA, Dr. Califf worked to improve diversity in clinical trials and to advance the use of real-world evidence in clinical trials to support regulatory decisions. He also spearheaded two important White House initiatives: the Precision Medicine Initiative and the Cancer Moonshot.

Regarding the former, Dr. Califf was pivotal in promoting FDA’s precisionFDA tool—a high-performance computing platform aimed at advancing precision medicine (i.e., the tailoring of FDA-approved treatments to specific characteristics of individuals). Dr. Califf further oversaw FDA’s development of its approach for the submission and review of data supporting the clinical and analytical validity of tests using next-generation sequencing (NGS).

For the realization of the Cancer Moonshot initiative, which was the then-Vice President Biden’s project, Califf worked closely with Biden to help solidify the initiative’s ambitious goals to accelerate scientific discovery in cancer, foster greater collaboration, and improve the sharing of data. As part of the initiative, Califf also helped to form FDA’s Oncology Center of Excellence, whose goals are to expedite the development of novel combination products and support an integrated approach to combat cancer.

Dr. Califf’s confirmation is welcome news, following more than a year without a permanent FDA commissioner. However, the Senate 50-46 vote was far from a clear mandate (six Republicans supported the confirmation and five Democrats opposed it).

As FDA commissioner, Dr. Califf will certainly have a number of areas to address in short order, including the ongoing COVID-19 pandemic and future pandemic preparedness. Topics that will likely be on Dr. Califf’s shortlist include FDA’s efforts toward regulations and policies concerning CBD-containing products, e-cigarettes, and Emergency Use Authorization (EUA)-approved COVID-19 medical devices and therapeutics. Dr. Califf is also likely to address the accelerated approval pathway, including what has been termed “dangling” approvals (products for which phase four studies did not confirm a clinical benefit), FDA’s opioid policy, and clinical trial reform and data transparency, as well as approval standards and the exercise of regulatory flexibility for products for rare and serious diseases. Finally, Dr. Califf is expected to be involved in the upcoming Prescription Drug User Fee Act (PDUFA) re-authorization, as the current version of PDUFA will be expiring at the end of fiscal year 2022.

However, if the Senate vote is indicative (not to mention the unprecedented public attention focused on FDA as a result of the COVID-19 pandemic), Dr. Califf and FDA may be subject to increased congressional scrutiny, potentially pulling regulatory attention to congressional priorities and making it more difficult for the new commissioner to address policy changes that have traditionally been an internal FDA matter.