Picture by Paola RodriguezRobert Califf, M.D., M.A.C.C., talking with an attendee at Well being Journalism 2022.
Meals and Drug Administration (FDA) Commissioner Robert Califf, M.D., M.A.C.C., isn’t straightforward to rattle.
Throughout a Q&A on Friday, April 29, at Well being Journalism 2022 in Austin, he instructed journalists that after “surviving a harrowing affirmation course of” he’s feeling assured concerning the FDA’s capacity to sort out the entire challenges earlier than it, together with meals security, kids’s COVID vaccines, teen vaping, amongst others.
Although the company has been hit with criticism from lawmakers, trade and the general public, he’s taking it in stride.
“I’m 70 years previous. I’m comparatively impervious to critique. What are they going to do to me now?” he mentioned through the session moderated by AHCJ’s core subject chief on affected person security Kerry Dooley Younger.
However the difficulty that retains him up at night time, he mentioned, is the proliferation of false and deceptive well being data, notably on-line — and the mistrust in establishments, information and experience that it has wrought.
“I imagine that misinformation is now our main reason for loss of life,” he mentioned, naming ongoing COVID-19 vaccine hesitancy, the variety of folks taking Ivermectin and the prevalence of vaping as examples of the issue. “Traditionally, the FDA has been comparatively quiet and places out definitive data by way of steering or labels or regulatory actions … that might be transmitted to customers and sufferers by way of trusted intermediaries. However the world has modified at this level.”
All this, he argued, had fueled the drop in life expectancy within the U.S. in comparison with different rich nations, and he urged reporters to keep away from clickbait, lean into truth checking, be certain the headline matches the copy and take different steps to responsibly convey information about COVID-19 and different urgent well being issues.
“Persons are distracted and misled by the medical data Tower of Babel,” he mentioned. “However journalists like yourselves play an necessary function right here and your work has an incredible influence on public belief.”
Following his opening remarks, Califf took questions from a number of AHCJ members a few vary of newsy points on the FDA’s plate just like the controversial approval of an Alzheimer’s drug, the rise in opioid-related deaths and the continuing battle to authorize a COVID-19 vaccine for younger kids.
When requested concerning the obvious disconnect between FDA approving the drug Aduhelm to deal with Alzheimer’s — regardless of weak proof of its efficacy — and CMS refusing to cowl the expensive treatment — Califf disputed that the totally different companies had been at odds.
“It wasn’t a contest between FDA and CMS. We have now totally different jobs,” he mentioned. “CMS has an ordinary for what it would fund and it’s not the identical as an FDA approval.”
Whereas refusing to provide his personal opinion on the choice to approve the drug, he voiced some skepticism concerning the impartial FDA panels that mentioned Aduhelm mustn’t get a inexperienced mild.
“Bear in mind, advisory committees are advisory,” he mentioned. “And 25% of the time, the FDA has decided totally different than the vast majority of the advisory committee. The overwhelming majority of these instances, the FDA was extra restrictive than the advisory committee really useful. So, it’s in no way uncommon to get recommendation from an advisory committee — who usually have many mental conflicts and tutorial biases and all types of issues — and never do precisely what the advisory committee recommends.”
Drug importation
When requested whether or not the Biden administration will grant requests from Florida and different states to import cheaper medicine from Canada, Califf mentioned that whereas he thought it was a poor strategy to get on the root downside of excessive drug costs, his private view is “irrelevant.”
“FDA is sort of a referee and the referees go by the rulebook,” he mentioned. “If a state meets the standards which might be within the guidelines, we’ll act rapidly to approve them … and give you a system that goes by the standards laid out not by me however by my predecessors.”
Nonetheless, he burdened, a greater answer is to undertake the direct authorities negotiation system Democrats have been struggling to cross by way of Congress.
“The way in which to get a lower cost is to barter with the individual promoting them,” he mentioned.
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