What Dr. Califf Told Us About His Plans for FDA
FDA Commissioner Robert Califf (bio here) joined the Alliance for a Stronger FDA for a fireside chat on Tuesday, July 12, 2022. The wide-ranging discussion is summarized below, as well as covered in the following news stories: Regulatory Focus; Endpoints News; Fierce Biotech; BioWorld (free registration required); Prevision Policy (pdf); and Pink Sheet (article available without subscription).
Califf On His Priorities and Vision. In a wide-ranging discussion Dr. Califf reaffirmed two key FDA funding priorities: data and technology modernization and hiring additional highly skilled personnel.
He also pointed to two meta issues that concern him:
dealing with misinformation provided to the public which involves all science and goes beyond just FDA, and
developing an evidence generation system to improve evidence supporting FDA decisions (referencing both food safety and medical products)
Califf on FY 22, FY 23, and User Fee Funding. When asked about the implications for FDA operating under a Continuing Resolution (CR), he said that a CR puts limitations on what can be done. He was particularly concerned that a CR would limit FDA’s ability to develop new tools to deal with what he called “predictable surprises” – events for which we should be prepared even though we do not know precisely what they might be.
There are enormous implications if user fees are not renewed. FDA will need to lay off people. Until that is resolved, he wondered, rhetorically, who would want to risk working at FDA with these uncertainties. He also emphasized the implications for the public if FDA cannot meet its commitments.
Califf on Pandemic Preparedness – Ebola and Zika showed what could be done. However, the stockpile is in disrepair. Supply chain problems existed before COVID, with a lack of resilience due to just-in-time approaches linked to single contracts. COVID taught us how public and private systems can work together and be ready for a national problem.
Califf on Food Safety Priorities. Dr. Califf said appropriations for food have not kept pace with other FDA activities. FDA has good plans for advancing food safety, but there is the need to bring the plan and funding together. While work on medical products has been robust, due in large part to the 21st Century Cures Act, there is work to do on the food side which in his view has faced “massive underfunding.”
The New Era for Food Safety has the right ideas. But there is a need for interaction across federal, state, and county systems. The right technology can facilitate these efforts.
Califf on Medical Misinformation. Dr. Califf has always believed that evidence-based medicine is the right way to do things. He saw efforts at Google to deal with misinformation, which travels further and faster than true information. No particular solution is evident at this point. The federal government alone cannot solve the problem. A network of people is needed, as is a strategy to deal with the avalanche of information on the internet beyond what is provided on a drug label.
The entire webinar with Dr. Califf can be accessed here and a written transcript will be available next week. It will appear first on the Alliance’s website (www.strengthenfda.org) and will also be distributed via next week’s Friday update.