CQ News
At FDA spending hearing, avian flu worries dominate
By Ariel Cohen, CQ
Food and Drug Administration Commissioner Robert Califf Wednesday urged lawmakers to back the agency's new spending on food safety, arguing it is more crucial than ever given the potential spread of the H5N1 avian flu.
During a Senate Agriculture Appropriations Subcommittee hearing on the FDA's fiscal 2025 budget request, Califf said the agency is revamping its food safety and inspections program in the wake of the 2022 baby formula crisis, and currently is doing daily inspections to ensure America's dairy products supply is free of the spreading bird flu.
The FDA is also preparing vaccines and antivirals in case the bird flu spreads to humans, he said.
The administration requested $7.2 billion for the FDA’s fiscal 2025 budget, Califf said, an increase of $341 million above 2024 enacted levels (PL 118-42). That includes nearly $3.7 billion in discretionary funding — a $168 million increase.
Subcommittee Chairman Martin Heinrich, D-N.M., said the requested increase is "relatively modest for this agency," but given Congress' tight purse strings, it's unlikely the agency will receive all the funds it needs.
"Last year we had to make some pretty difficult budget decisions under grim spending caps and I'm afraid that it's likely this year will not be much better,” Heinrich told Califf. “That's why it's important for us to hear your priorities.”
Califf told the committee that the FDA is planning the largest reorganization in its history this year, impacting roughly 8,000 of its 18,000 workers.
The center of this reorganization is the new Human Foods Program to improve oversight of food safety and to increase the focus on all food and drug inspections. The agency will shift tobacco products, cosmetics and specialty labs into the Office of the Chief Scientist.
Avian flu
Several lawmakers, including Heinrich and subcommittee ranking member John Hoeven, R-N.D., expressed concern about the spread of the H5N1 avian flu. There has been one human case of the virus this year. That person, a Texas dairy farm worker in contact with infected cows, got conjunctivitis by rubbing their eye, a relatively unconcerning outcome that was caught quickly before it could worsen.
The bigger issue, Califf said, is if the disease goes unchecked and spreads to the human lungs.
When that has happened in other parts of the world for brief outbreaks, one in four who contract the disease die — a much worse mortality rate than COVID-19.
The FDA and Department of Health and Human Services are preparing antivirals, vaccines and other preparedness measures in case the virus makes a major jump to humans, Califf told the lawmakers.
The FDA and National Institutes of Health are working in tandem to create an mRNA vaccine to prepare for a potential widespread virus jump to humans.
"We don't control how the virus mutates. Viruses are always mutating. It's a mathematical, probabilistic thing," Califf said. "So we have to be ready and we have to do everything we can to limit the spread of the virus."
Califf sought to reassure the public not to worry right now. Still, experts are worried about the possibility of mutation, as this virus has moved from birds to cows, which can be in contact with pigs or farm workers.
There is no single way to contain the virus and prevent spread, but having farm workers wear personal protective gear is a solid preventive measure, Califf said.
Abortion drug
Although Republican Sen. Cindy Hyde-Smith of Mississippi tried to get Califf to talk about the mifepristone prescriptions offered via telemedicine, Califf told her there's only so much he could say given the Supreme Court case that could potentially curb the abortion drug's use.
But he reiterated that mifepristone is safe and effective for its intended use and said the FDA does not encourage stockpiling of the drug.
Sen. Patty Murray, D-Wash., meanwhile told her colleagues that politicization of the FDA makes it more difficult for the agency to carry out its core functions: drug and food oversight and safety.
Drug shortages
Lawmakers also briefly questioned Califf about ongoing drug shortages. Califf partially blamed the shortages on a market failure.
Innovators who make patented drugs make good money, he said, but generic drug makers struggle more. He encouraged lawmakers to regulate pharmacy benefit managers and other drug middlemen to smooth the system.
"Unless we fix the market failure, we at FDA are just going to be plugging more and more holes in the system that we could have predicted in the first place," Califf said.
The page for the still undrafted fiscal 2025 Senate Agriculture spending bill is here.