'Misinformation Still a Major Issue for Government': Califf

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

"I've argued that misinformation is actually the leading cause of death in the United States today," said Califf. "We have a lot of effective treatments ... for most of our health problems, but there's so much misinformation causing people to make decisions that are adverse to their health."

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

On another front, Califf's agency announced this month that foreign manufacturers would be allowed to sell baby formula in the U.S., in an attempt to combat a formula shortage that has been impacting the country since February as well as break up the near oligopoly that three companies hold over the formula market. The FDA intends to incorporate foreign plants into their network for regular inspection, despite staffing shortages, Califf said.

"We fully intend to inspect those plants just as frequently as the U.S. plants, because if there's one thing we've all learned from this ... it's that infant formula is the sole source of nutrition for a lot of infants," he told MedPage Today. "We do need more people, but we're just going to beg, steal, and borrow from parts of the FDA until we get this one right, including the foreign plants."

Califf's later claim that "I think the good news now is that people can find infant formula" comes just 9 days after Rep. Rosa DeLauro (D-Conn.) sent out a tweet encouraging parents to share their experiences of struggling to access formula, and to include photos of their out-of-stock grocery stores. "Across the country, parents and caregivers are still struggling to find infant formula on shelves," she wrote. "We need to know the communities that are in need."

Califf has also ordered an external review on the FDA's tobacco division, which comes less than 2 months following the FDA's ordered removal of Juul Labs's vaping products from the market. It has also been nearly a year since the court-appointed deadline for the FDA to finish reviews for e-cigarette marketing applications, and moving forward, under new leadership, will be a lengthy process into unfamiliar territory.

Califf listed three areas of tobacco regulation on which he plans to focus. "One is completing the regulatory activity and the enforcement," Califf said. "A second is the issue of menthol, where the decisions on menthol vaping have been deferred. A third is the area of going forward with the rules about cigars and menthol cigarettes. And then, of course, we have on the common agenda a reduction of nicotine -- in the product itself -- to a sub-addictive level as a goal."

Califf also addressed opioid concerns, noting that the FDA will offer further guidance for prescribers and even parents with concerns regarding addiction and overdose. "During the month of August, you'll see a very comprehensive framework that will come out," he said. "There is no magic bullet. There are dozens of things that need to be done. Each one is incremental, but if they're all done together, they could have a big impact."

Califf, who also served as FDA commissioner from February 2016 to January 2017, also explained why he came back 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 age 70, when I was looking at the situation, I knew there were going to be some very hard things to do, and that it was going to take someone with a strong ego and not much at stake in terms of future career." He added: "I consider this to ... most likely be my last job."

https://www.medpagetoday.com/washington-watch/fdageneral/99979