FDA commissioner spells out agency's top priorities, with a focus on dispelling misinformation
It’s been a little more than six months since FDA commissioner Rob Califf won Senate confirmation, and while he highlighted some of his key goals early on, he offered the agency’s latest array of top priorities in a JAMA viewpoint yesterday afternoon.
At the top of the list, even as general fatigue has taken hold among the public’s perception toward the pandemic, is Covid-19, and the ongoing opioid addiction crisis, which took more than 100,000 lives in 2021.
Califf, who has generally avoided the spotlight since taking over FDA, notes that both the Covid-related and opioid-related death rates in the US are too high, and the US trails high-income countries on Covid-related vaccination and death rates, adding:
The clinical community must remain resilient and work toward more equitable delivery of evidence-based therapies. Substantial disparities in COVID-19 vaccination rates and use of therapeutics will be closed only with a proactive approach by clinicians. Furthermore, the US public has been exposed to highly variable recommendations on social media and in professional circles about COVID-19 treatment and prevention. Broad collaboration is needed across clinical communities to promote reliable information about lifesaving vaccinations and treatments and counter the spread of medical misinformation.
This focus on combating misinformation is on full display with the FDA’s recently launched webpage on “Rumor Control,” which raised a few eyebrows as any government webpage attempting to control a storyline would. Messaging like, “Don’t believe the rumors,” may even end up being counterintuitive and difficult for the general public to understand in context if the FDA isn’t disputing particular rumors beyond the four listed.”
Another major priority focus Califf points to is around “evidence generation,” a topic that’s been a part of his career from the beginning as one of the nation’s top clinical trial experts.
“When the FDA’s decisions generate controversy, it is often when the system fails to produce reliable evidence that clarifies an intervention’s risks and benefits during a relevant time frame,” he explains. “The gap between FDA clearance or approval of a medical product (particularly when the accelerated approval pathway is used) and use of the product to treat patients should be filled by an invigorated clinical research system that generates evidence that patients, clinicians, and health systems need to make well-informed decisions.”
Last month, Califf also made clear that his second stint as FDA commissioner will embrace new data, perhaps harkening back to his recent work with Google’s parent company Alphabet, where he led the firm’s policy work.
“Our delivery of evidence to support decision making is a fraction of what it ought to be given the technological expertise that we have globally and in the United States,” Califf said at an Alliance for a Stronger FDA event. “When the evidence is good, we still have our arguments about how to interpret it, but it’s entirely different when the FDA has to make a decision by a user-fee mandated day, and the evidence is not entirely clear, and a decision is still needed.”
Continuing Califf’s interest in pushing FDA decision-making further into the space of real-world evidence, he explains how “[i]nnovative uses of data can refine current approaches to identifying differences in health outcomes across the population and inform necessary interventions to improve outcomes for all. Inequities associated with race and ethnicity, age, sex, gender, and socioeconomic factors are readily apparent through the lens of geospatial data.”
And while the digital data ecosystem has helped to propel accurate diagnoses, it hasn’t done enough to close certain equity gaps, and it’s “been contaminated by misinformation and disinformation,” he adds, calling on FDA again to be “more proactive in preempting and countering misinformation.”
While FDA is focused on improving clinical trial diversity, Califf said that unless data sharing improves, “these solutions will fall short of their potential.”
On opioids, he also notes how the problem “has been worsened by easy access to potent, low-cost fentanyl and methamphetamine synthesized on large scales in illicit factories and distributed via refined systems. The FDA will redouble efforts to enhance access to naloxone, improve prescriber education, and encourage development of new therapies for pain and substance use disorders.”
