The Food and Drug Administration gets a new commissioner Dr. Robert Califf, succeeding Dr. Janet Woodcock, who served a year-long tenure as acting commissioner following the change in administration.
“Dr. Califf’s previous service in this role, his career as one of the nation’s leading research scientists, gives him the experience to take on this challenge,” said Sen. Patty Murray, chairwoman of the Senate Committee on Health, Education, Labor and Pensions (HELP).
The Senate confirmed Califf Monday in a 50-to-46 vote. Califf will be responsible for managing FDA's full portfolio, including assuring the safety, effectiveness and security of drugs, vaccines, biological products and medical devices; the safety and security of the national food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.
“I urge my colleagues to support Dr. Califf’s nomination because he will provide the leadership needed to promote today’s biomedical advancements and help to pave the way for tomorrow’s innovation,” Sen. Richard Burr said during the confirmation hearing.
Senators and federal leadership have highlighted the importance of having a permanent commissioner to spearhead FDA’s growing list of priorities, including COVID-19 response. The agency plays a key role in the availability and regulation of vaccines, tests and treatments.
In addition to the ongoing COVID-19 pandemic, FDA is currently balancing multiple high-level priorities like e-cigarette marketing applications, battling the ongoing opioid crisis, bolstering and securing supply chains and advanced biologics manufacturing capabilities to prevent shortages, and communicating with the public about these issues.
Califf previously served as FDA commissioner from February 2016 to January 2017. Prior to this first FDA term, Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University.
FDA also filled its chief technology officer position last week. The agency appointed Sohail Chaudhry as permanent CTO, after serving in an acting capacity since 2015.
“I am personally delighted to see Sohail Chaudhry be appointed to the CTO role to help progress our TMAP and DMAP plans,” FDA CIO Vid Desai said in a LinkedIn post last week.
As permanent CTO, Chaudhry will be responsible for the implementation, operations and maintenance of IT, and leading the development of appropriate technology solutions to support federal policies and directives. He will also help merge the recommended technologies with the strategic business objectives of the organization.
“At the end of the day, we want to work with innovative partners to help us meet our mission effectively and securely, building upon the foundation that’s laid within our TMAP and DMAP. We plan on expanding our use of machine learning in regulatory inspections, reviews, discovery and responses to promote and protect public health across the agency,” Chaudry told GovCIO Media & Research.
The appointment follows FDA’s September 2021 launch of its Office of Digital Transformation, which was realigned to report directly to the FDA commissioner. With the new leadership appointments and realignment, FDA will be better positioned to tackle cross-agency priorities to support FDA’s overall mission.