FDA Commissioner Robert Califf told lawmakers he’s ready to work with them to bring more drug manufacturing to the US and laid out the agency’s progress to ramp up overseas inspections at a congressional hearing Thursday.
Appearing before a House Appropriations panel to defend the agency’s budget request for fiscal year 2025, representatives peppered Califf with questions about how the FDA can play a role in reshoring overseas generic drug manufacturing to the US. He also told the panel that while challenging, the FDA has made some progress in conducting more unannounced inspections overseas.
“What we’ve learned so far is we can do it,” he said. “It costs more than two times as much for each inspection because of the logistics, the support that’s needed, the travel.”
Califf told lawmakers that the FDA has conducted 100 unannounced inspections in India and is up to the “double digits” in China. He said that the number of foreign inspections the FDA conducts isn’t back to pre-pandemic levels but pointed out that digital tools have allowed the agency to check in on facilities in between inspections.
Lawmakers also pressed Califf on efforts to bring foreign manufacturing to US soil, asking him what the FDA can do to help with reshoring.
“We have eight billion people in the world. They all need access to generic drugs that are high-quality and low-cost,” he told the panel. “We have a special need here. And if there’s an effort that’s policy-driven to do it, we want to play our role.”