Misinformation remains a major problem for government, says FDA chief

As the COVID-19 pandemic drags on and monkeypox cases are on the rise, misinformation is still a major hurdle for healthcare professionals and government agencies to overcome, FDA Commissioner Robert Califf, MD, at a briefing sponsored by the Health Policy Alliance. .

“I argued that misinformation is actually the number one killer in the United States today,” Califf said. “We have a lot of effective treatments…for most of our health issues, but there’s so much misinformation that’s causing people to make decisions that are detrimental to their health.”

Califf also spoke about increasing the efficiency of the FDA’s evidence generation system, citing the University of Oxford’s Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial as an example of what the agency could aim for. He suggested increasing sample sizes and integrating clinical trials into clinical practice as ways to gather evidence and receive faster answers to scientific questions.

On another front, the Califf agency announced this month that foreign manufacturers would be allowed to sell infant formula in the United States, in an effort to tackle an infant formula shortage that has plagued the country since February and to break the quasi-oligopoly that three companies hold the formulas market. The FDA intends to incorporate foreign factories into its network for regular inspections, despite understaffing, Califf said.

“We fully intend to inspect these factories as frequently as American factories, because if there’s one thing we’ve all learned from this… it’s that infant formula is the only source of nutrition for many infants,” he said. MedPage today. “We need more people, but we’re just going to beg and steal and borrow from parts of the FDA until we get this one right, including foreign factories.”

Califf’s subsequent assertion that “I think the good news now is that people can find infant formula” comes just 9 days after Rep. Rosa DeLauro (D-Conn.) tweeted encourage parents to share their experiences of struggling to access formula and include photos of their out-of-stock groceries. “Across the country, parents and caregivers are still struggling to find infant formula on the shelves,” she wrote. “We need to know the communities that are in need.”

Califf also ordered an external review of the FDA’s Tobacco Division, which comes less than 2 months after the FDA-ordered removal of Juul Labs’ vaping products from the market. It’s also been nearly a year since the court-set deadline for the FDA to complete reviews of e-cigarette marketing applications, and moving forward under new leadership will be a long process in uncharted territory. .

Califf listed three areas of tobacco regulation he plans to focus on. “One is to complete regulatory activity and enforcement,” Califf said. “A second is the issue of menthol, where decisions on menthol vaping have been deferred. A third is the area of ​​advancing the rules on cigars and menthol cigarettes. And then, of course, we have to l common agenda a reduction of nicotine – in the product itself – to a sub-addictive level as the goal.”

Califf also addressed concerns about opioids, noting that the FDA will offer additional guidance to prescribers and even parents concerned about addiction and overdose. “During August you will see a very comprehensive framework coming out,” he said. “There is no silver bullet. There are dozens of things to do. Each is incremental, but if all done together could have a big impact.”

Califf, who also served as FDA commissioner from February 2016 to January 2017, also explained why he returned for a second time. “I’m not looking for sympathy,” he said. “My wife reminds me every day that I chose to come back, I had no reason to have to come back. But at 70, when I looked at the situation, I knew there would be very difficult things to do. , and that it was going to take someone with a strong ego and low stakes in terms of a future career.” He added: “I consider this to be…most likely my last job.”

About Margaret Shaw

Check Also

What is snuff? – CStore Decisions

Snuff, a variety of smokeless tobacco, remains a popular product in convenience stores and smokehouses. …