The Food and Drug Administration is requesting additional funding in its fiscal year 2022 budget to bolster data modernization, secure and strengthen supply chain, transition to cloud and develop new technology solutions.
In late May, FDA submitted a $6.5 billion budget request as part of the White House's FY 2022 budget — $477 million more than the agency’s fiscal year 2021 funding level, to better support critical public health infrastructure, core food safety and medical product safety programs.
Speaking to the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, Dr. Janet Woodcock, FDA’s acting commissioner, said that the additional funds will improve FDA’s performance and enable the agency to modernize operations.
“The budget I present to you today will directly support our efforts to evolve and modernize how we accomplish our mission, our workforce and operations,” Woodcock said. “We’re embarking on a multi-year effort to upgrade and modernize our physical and technological infrastructure.”
FDA has requested $185 million to improve the critical public health infrastructure. The agency plans to allocate $76 million of that funding to advance its data modernization efforts.
“Technological advances have and will continue to revolutionize human and animal health … As a byproduct of these exciting advances, the amount and variety of data that FDA generates, needs and uses is rapidly increasing, but we’re often hampered by antiquated methods,” Woodcock said.
These additional funds would enable FDA to modernize its data infrastructure, better gather information and identify, analyze and respond to potential challenges faster.
One area where FDA would direct its infrastructure modernization is in the supply chain. In addition to the $76 million directed to its data modernization efforts, FDA has requested an additional $22 million to build out a supply chain program.
“Medical products supply chain issues have been a constant challenge, especially in the height of the pandemic, with critical shortages. We want to continue to play a role in fixing this issue going forward,” Woodcock said.
By strengthening the domestic supply chain, FDA will promote advanced manufacturing to streamline and prioritize inspections and approvals for new domestic facilities.
“Advanced manufacturing doesn’t use the methods that have been used for 100 years, but uses advanced, continuous methods … These are very innovative and can be brought up much more speedily,” Woodcock said.
In order to make advanced manufacturing a standard, FDA must develop a new regulatory framework.
To do this, the agency is creating a new center of excellence that will help launch these facilities. Woodcock said that modernized manufacturing efforts would naturally have a better quality maturity because it’s a computer controlled process with small tolerances.
Another way FDA is modernizing its operations is by leveraging emerging technologies, like cloud, into its inspection program. Because of FDA’s antiquated IT systems, the agency is struggling to move systems to the cloud and improve system interoperability.
Moving forward, FDA will also evaluate how remote inspection tools could help reduce the backlog caused by COVID-19. While it’s not a substitute for in-person inspections, Woodcock noted that this method could help augment information.
“Much of the technology and data ask is going to be working on the food establishment inventory to get that correct, digitized and quality controlled,” Woodcock said. “[FDA] will also upgrade the field systems so that they all talk to each other and are integrated … so we have all the information at our fingertips.”