Editorial: With Califf confirmed, FDA needs to return to priorities lost to the pandemic and improve its messaging
The pandemic is by no means over, and the FDA will surely continue to prioritize the necessary EUAs for additional therapies and targeted vaccines as well as other measures to bring down the ballooning death toll.
In fact, the first big item on newly Senate-confirmed FDA commish Rob Califf’s plate will be the ordeal around Pfizer’s vaccine for the youngest children.
The FDA last week rubbed egg on its own face by not only calling for Pfizer to submit data, but scheduling an adcomm to review the data on this lowest-dose vaccine, contemplating starting with two doses before waiting for data on a third.
But as the adcomm drew close, FDA pulled back and postponed it after receiving some “late-breaking” data from Pfizer. Instead, the agency decided to just wait for the third dose for these youngest children, confirming what Pfizer had said all along.
These are the kinds of own-goals the FDA needs to avoid under Califf.
He’s also going to have to come up with a plan to shepherd all of these Covid-related emergency use authorizations into full approvals as politicians seek to halt the public health emergency now that Omicron cases are waning, and as government funds may be scarce.
But beyond Covid, Califf will have to help usher in the latest negotiated deals for industry user fees, which fund the majority of the agency’s drug reviews. Congress has until the end of September to reauthorize the legislation and Califf will be the one who has to ensure the packages get passed.
Califf also can lay out some of his own agenda and target priorities that have fallen to the wayside over the past two-plus years, like reforming the accelerated approval pathway, which he’s promised Sen. Ron Wyden he would take on, and cementing how the agency uses real-world evidence (randomized or not) in its decision making.
Lucky for Califf, both Janet Woodcock, at least to start, will be there to support him with her 35+ years of agency experience, and Peter Marks at CBER will continue to explain vaccine decisions as only he can.
While Woodcock previously told me that FDA isn’t really in the business of policing misinformation about Covid-19 vaccines, Califf may turn over a new page here too.
“I’m going to be very aggressive in this area of medical misinformation,” he told senators on the health committee.
Indeed, the FDA under Califf should take a page out of Scott Gottlieb’s book and better explain each decision, not only to the public but to the media too (to avoid headlines like the one in NBC News last week that said, “Pfizer pulls FDA request for Covid vaccine for kids under 5”).
This is important also because so many Americans have lost faith in government-run scientific institutions and because Marks and others at the agency are very articulate in explaining what’s going on. At the very least, those experts should be speaking to the media more regularly.
While it’s understandable that an agency like FDA has to keep confidential industry data secret, the agency still needs to do more than just issue a PR, and then copy and paste bits and pieces of that PR in responses to media. Make senior officials available for discussions, find new ways to communicate with the public, and most of all, stick with the data. That shouldn’t be a problem for Rob Califf.
