The House Energy & Commerce’s subcommittee on health heard from the directors of the FDA’s device, biologics and drug centers on Wednesday for a “check up.” Representatives peppered the officials on topics ranging from generic drug manufacturing to the agency’s new rule on lab-developed tests.
Committee Chair Cathy McMorris Rodgers (R-WA) questioned FDA drug center director Patrizia Cavazzoni about on-shoring and near-shoring drug manufacturing. Rodgers said that the FDA is sometimes an “impediment” to incentivizing manufacturing in the US.
Patrizia Cavazzoni“We are also very concerned about the lack of redundancy, resilience and lack of geographic diversity in the supply chain, and we remain very interested in working with Congress to address those issues,” Cavazzoni said.
On improving diversity in clinical trials, Cavazzoni said it should be a “a matter of days” before the FDA publishes guidance outlining sponsors’ responsibilities to make clinical trials more diverse and inclusive. The guidance is tied to a requirement from the Food and Drug Omnibus Reform Act of 2022, which directs drug companies to submit diversity action plans to the FDA ahead of key trials.
Responding to a question on drug shortages, Cavazzoni reiterated the FDA’s request be granted for authority to require manufacturers to report increases in demand, which have led to several shortages of acetaminophen and antibiotics over the past year.
Rep. Brett Guthrie (R-KY) criticized the agency for its recent final rule outlining how it will regulate laboratory-developed tests as medical devices.
Lawmakers have for years been considering passing legislation that would overhaul how the FDA regulates in vitro diagnostics and establish a user fee program for LDTs, but have yet to pass any bill. Guthrie said that the new rule will create “onerous requirements” for LDT makers.
Rep. Larry Bucshon (R-IN) who sponsored a bill to establish an LDT framework, asked FDA device center director Jeff Shuren whether he supports Congress intervening.
“We’re certainly happy to work with Congress and understanding that VALID [Bucshon’s bill] would put in place a more modern framework for in vitro diagnostics, but in the absence of it, I’ve got to tell you today, we continue to see problematic LDTs,” Shuren said.