Woodcock Updates Senate on Budget Request
Acting FDA commissioner Janet Woodcock outlined agency budget priorities during a 6/10 Senate Appropriations subcommittee hearing, which included data modernization, supply chain improvements, and the inspection backlog. She told subcommittee members that the agency is requesting a $76 million increase to support data modernization efforts. “As witnessed firsthand during the Covid-19 pandemic, technology has and will continue to revolutionize human and animal health,” she said in her testimony. “Scientific breakthroughs have enabled the development of new, more personalized therapeutic treatments, advanced manufacturing, and state-of-the-art solutions such as blockchain, genomic information, and real-time analytics. As a byproduct, the amount and variety of data that FDA generates, needs, and uses is rapidly increasing at exponential rates. However, the Agency utilizes antiquated methods, including inspecting large volumes of PDFs, often ‘by hand,’ in order to identify critical safety signals, such as human and animal drug and device safety concerns or emerging foodborne outbreaks.”
Another budget priority, according to Woodcock, is easing the medical product supply chain’s dependence on foreign medical products. The budget request seeks a $21.6 million increase for a new Resilient Supply Chain and Shortages Program at CDRH. “This funding will provide resources to establish a permanent program for U.S. supply chain resilience for medical devices for the first time,” she said in her testimony. “The funding will help to stand up this program that will focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply short-falls, continuing surveillance, and rapid intervention.”
Regarding inspections, FDA is requesting an increase of $18.8 million to help with “Covid-19 recovery activities including inspectional modernization, preparing to adjust staffing and onboarding new staff to support onsite inspections,” according to Woodcock. “The resources requested as part of the FY 2022 budget will allow ORA to maintain the staff hired with supplemental funding and increase our foreign inspection teams. We are also actively working to expand upon the use of remote assessment tools where appropriate, such as remote livestreaming video of operations, teleconferences, or screen sharing. These remote assessments, used in combination with other tools, enable the FDA’s investigators to assess the level of compliance and process control at sites.”
Subcommittee chair Tammy Baldwin (D-WI) told Woodcock that the agency is taking too long to approve manufacturing facilities in the U.S. and wondered what could be done to speed up regulatory approvals to improve domestic supply chains. “FDA has been working for some time on improving manufacturing and getting to advanced manufacturing, which we think for pharmaceuticals is the way we are able to bring manufacturing back into this country,” Woodcock responded.
“Advanced manufacturing,” she continued, “doesn't use the methods that have been used for 100 years, but uses advanced continuous methods, both for synthesis of compounds and making the final dosage form. These methods, and the factories that relate to them are very innovative and actually can be brought up much more speedily because of the methods that they use. They use computer control, rather than paper records. They don't stop for testing and so forth. They're much smaller, they have better environmental footprints and so many of those obstacles as regulatory obstacles are diminished. However, we must make a new regulatory framework for this type of advanced manufacturing, and we are working... on a new center of excellence that will help bring these facilities along.”
Senator John Hoeven (R-ND) asked Woodcock about FDA’s drug inspection backlog, and the importance of resuming both domestic and foreign inspections. She said the agency was able during the pandemic to act on over 90% of premarket application submissions. To date, there are 68 product applications that are waiting for an inspection before the agency will make a review decision. The other backlog is surveillance inspections and until FDA gets caught up there will be more time between these routine inspections, she said.
Woodcock also told Sen. Hoeven that the budget request seeks resources to “overhaul how we operate our inspectional program. Our IT systems are completely antiquated, many of them are at the end of service or end of life. They don't talk to each other, and we can't get them on the cloud because they're too antiquated.” Additionally, she said FDA is going to use remote assessments “where people wear cameras and so forth and go around the plants. They wouldn't substitute for in-person inspections, but they will augment the information that we get. So, we are committed to getting our inspectional program back up and running fully by this summer, to the extent we can domestically.” Internationally, it's going to depend on the state of the country because in many parts of the world the pandemic is still raging, she said.