FDA Commissioner Rob Califf told the Senate Appropriations Committee on Wednesday that milk products are safe from the H5N1 bird flu virus that’s circulating, and the FDA is working with mRNA vaccine manufacturers to try to scale up production in case the virus “jumps into humans on a larger level.”
The FDA has been coordinating closely with the CDC, NIH and USDA to tackle the spread of H5N1, which Califf noted was found in about 20% of a national sample of raw milk. But pasteurization continues to keep the milk safe, and Califf said both the NIH and university agricultural researchers found the same to be true. Califf testified before the committee on Wednesday as part of the FDA’s 2025 budget request.
“The countermeasures in case this does jump to humans: You have to have testing, antivirals and a vaccine ready to go. So we’ve been busy in case it jumps into humans on a larger level,” Califf said.
In response to questions from Sen. John Hoeven (R-ND) about the virus already jumping to humans, Califf noted the one case was conjunctivitis, and not a serious illness. But if it “jumps to human lungs,” the mortality rate could be worse than Covid-19, Califf said. The mortality rate for cattle is less than 1%, he noted, but workers need to be protected with personal protective gear.
“We don’t control how the virus mutates,” Califf said.
He later explained that the FDA is confident in the mRNA templates and platforms that can be quickly deployed. NIH “is doing a lot of the background work to characterize the virus” so we can be ready to “work with industry to make the vaccines,” he said.
“We’re in an enviable position compared to any time in the history of the world,” Califf added. “Viruses are relatively simple, so coming up with a matching vaccine is entirely possible in a short period of time.”
On the topic of advisory committee reforms, Sen. Joe Manchin (D-WV) questioned why the number of votes might be reduced, but Califf said votes are not going “completely away.” Two top leaders from the FDA previously said the reforms will not eliminate votes from adcomms.
“What the FDA is most interested in is what the advisory committee is thinking. That’s much more important than the excitement of the vote,” Califf added.
Manchin also raised concerns with opioids that must be approved by the FDA even if they aren’t any better than any currently-marketed opioids, and Califf said Congress needs to provide the agency with a new statute that allows it to address whether new opioids are better than existing ones.
“You need language basically saying if it’s an approved drug that will perform better than the existing drug, we will remove the existing drug?” Manchin asked, and Califf agreed.
In response to questions from Sen. Cindy Hyde-Smith (R-MS) over obtaining the abortion drug mifepristone without meeting with a doctor, and the “stockpiling” of the pills, Califf explained that people still need a prescription for mifepristone and that the FDA doesn’t regulate the practice of medicine.