FDA’s Califf shares priority list with agency staff

Regulatory NewsRegulatory News | 18 February 2022 |  By 

Robert Califf

Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for Robert Califf as he retakes the helm of the US Food and Drug Administration (FDA).
Califf’s priorities were outlined in a 17 February memo to FDA staff, as well as on his new official Twitter feed (@DrCaliff_FDA). Califf was as confirmed as commissioner for the second time on 15 February by a narrow win in a 50-46 vote and sworn in two days later. Califf, a cardiologist, previously headed FDA during the final year of the Obama administration and is a founding director of the Duke Clinical Research Institute (Related: Senate confirms Califf as FDA commissioner, Regulatory Focus, 15 February 2022).
Califf said that he looks forward to “strengthening the FDA’s science foundation” and that one of his priorities is to counter misinformation about science. While not elaborating or pointing to real world examples, he may have been referring to the public’s misperception about the safety and effectiveness of COVID-19 vaccines and therapeutics. More than 920,000 people in the US have died of COVID as of 16 February, according to the CDC.
“These kinds of distortions and half-truths that find their way into the public domain do enormous harm, both by leading people to behavior that is detrimental to their health and by causing them to eschew interventions that would improve their health,” Califf wrote. “We must become more proactive and strategic to meet the part of our mission that reads: helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. Misinformation and disinformation undercuts the amazing work that you do, and a purely reactive mode is not appropriate, particularly in this new era of social media.”
Califf said that another “primary focus” is responding to the pandemic. Moving forward, he said, the agency will continue to develop additional responses to the pandemic, “building on what we have learned both in terms of responding to and preparing for public health emergencies and in developing solutions to many other public health challenges.”

He lauded the agency’s work in this area. “The energy and commitment of this agency has been critical to speeding the successful development of therapeutics, diagnostics, PPE, and vaccines, and has saved many lives, as your work has provided the nation and the world with a solid foundation for life saving medical products.”
Also among Califf’s priorities: strengthening the responses to the opioid crisis and addressing tobacco harms.
“With over 100,000 deaths from overdoses in the past year alone, we must accept that all the hard work so far has not been enough,” Califf wrote. “It’s also clear that successfully addressing this issue requires that, in addition to new approaches and redoubled effort from FDA, working with our partners in HHS will be essential.”
During his confirmation hearings, Calif faced stiff opposition on both sides of the aisle, with his critics citing his record on opioids, as well as his close ties to industry, and the agency’s actions related to the abortion drug mifepristone during his last term as commissioner.
Califf also said that he plans to focus on developing prevention strategies for tobacco use, including strategies for e-cigarettes. “Tobacco will kill nearly 500,000 Americans this year and countless people will suffer strokes, health attacks, renal and heart failure, amputations and cancer. Importantly, this includes preventing young people from using harmful tobacco products, including e-cigarettes,” he wrote.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you