What Dr. Califf Told Us During His Fireside Chat
On February 10, 2023, the Alliance for a Stronger FDA, hosted a wide-ranging and well-attended fireside chat with FDA Commissioner Robert Califf. He expressed appreciation for the Alliance’s work.
One of the first questions asked of Dr. Califf was to compare his earlier tenure as Commissioner (2017) and his first year back (2022). It was a theme that recurred in several subsequent answers.
Upon his return, Dr. Califf found an agency dealing with an unprecedented pandemic in addition to its usual tasks. He also noted that the environment in which the agency currently operates has evolved: the nation is more divided; FDA is obligated to respond to more misinformation; and matters outside the FDA are less collegial than they had been in 2017.
Among the positives: the 21st Century Cures Act has helped improve recruitment and strengthen the science base of the agency and there is growing recognition of the importance of data and technology modernization.
He made clear that the food side of FDA merits further attention and resources. Even though food personnel have been working hard, the need for additional support for food matters is a longstanding issue, not just a recent one. He announced that FDA has begun a search for a Deputy Commissioner for Human Foods and suggested that a new Director for the Center for Veterinary Medicine will be announced soon.
When asked about his plans for reorganizing food programs (including the Office of Regulatory Affairs (ORA)), Dr. Califf noted that he can only propose changes. The agency has lots of bosses – both in the executive branch and in Congress – and it has collaborators.
He also emphasized that the current conversation is not just about food safety, but nutrition as well. Califf suggested that FSMA (preventive controls) is a great template, but FDA is only part way down the road. Though FDA’s jurisdiction covers some 600,000 food entities, states are also deeply involved in the sector and provide more inspections than FDA. In light of those complexities, the nation needs an efficient infrastructure that delivers. FDA recognizes that there is a need to educate before regulating, with the states and FDA needing to come together.
Regarding data and technology modernization, it is critical for FDA to be prepared for the positives of what digitization can provide. His experience at Google showed him what can be done with data and technology, and he wants to move in this direction, although FDA cannot move as quickly as universities and private industry.
With respect to areas for improvement, Dr. Califf highlighted restoring and improving advisory committees, hiring personnel with new authorities on the food side, the need for sophistication on regulatory matters, and cross cutting initiatives that support the entire agency.
Dr. Califf said the cosmetics industry is enormous and growing. The agency has new authority in this space, but it will be an ongoing journey that begins with a better inventory of products that are out there. Though FDA has new authority, it has not so far been allocated additional specific fiscal resources for this work. He has not decided where cosmetics will reside within FDA, but said it is unlikely that it will be within foods.
Regarding accelerated drug approvals, he indicated support when there is an unmet need but said a follow up mechanism is needed.
Dr. Califf responded to several questions submitted by attendees, addressing a range of issues, including:
a strategic diagnostics plan on national scale for the next pandemic;
women’s health roadmap;
regulation of laboratory developed tests;
artificial intelligence;
EUA’s and moving them into regular approval; and
getting staff back into FDA facilities, while recognizing that FDA has been working in a hybrid mode since 2016.
Readers can find a full transcript of his remarks here.
Concluding his remarks, Dr. Califf said his proudest achievement over this past year has been taking on hard issues. In his words: he did not return as Commissioner to kick the can down the road.