FDA Inspection Council Holds 1st Meeting
FDA will hold its first FDA Inspectional Affairs Council meeting this week to discuss optimizing agency inspections on an enterprise- or cross-agency basis, according to associate commissioner for regulatory affairs Judy McMeekin. Speaking to an Alliance for a Stronger FDA update 7/14, she said the council comprises top leadership from each of the Centers and Office of Regulatory Affairs who are charged with providing insight on strategies and initiatives, such as the type of new technologies that can be used and how to optimize the agency’s inspection process. “It's really important that we have these discussions on policy issues surrounding inspections as a cross- agency and as an enterprise, so that we can ensure optimal agency resources across the agency, and really navigate the regulatory landscape for many years ahead.”
In May, McMeekin told the Food and Drug Law Institute that the council will look to provide “additional flexibility to enhance data-driven, risk-based oversight modeling across the agency.” It will also develop a multi-year strategic action plan to optimize the agency’s inspection program. “Looking to the future, ORA will continue to strengthen our inspection process through the council and, with innovative technology, enhance our response to outbreaks, streamline our recall process, and expand the use of artificial intelligence and machine learning to screen imported products,” she said.
The council was announced earlier this year by FDA acting commissioner Janet Woodcock in an update on how the agency will return to more traditional inspection activities. She also released a report, “Resiliency Roadmap for FDA Inspectional Oversight,” while acknowledging that the agency “experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted.”
Regarding long-term budget priorities, McMeekin told the Alliance that one priority is to increase the budget for medical product safety “to better meet the need for oversight due to the advancements in areas such as stem cells, vaccines and medical countermeasures... It's critical that our compliance and enforcement tools and authorities keep pace with the increases in our biologics and device inventory, as well as the medical product technology advances, such as stem cells, 3-D printers, and advanced manufacturing.” She said enhancing FDA’s IT platform is also important. “Data is at the heart of FDA work as a science-based agency, and we anticipate ongoing rapid increases in the amount and the complexity of the data that informs FDA regulatory decision making and its public health mission,” she said. “The amount and variety of data that the FDA generates and needs and uses is rapidly increasing at an exponential rate.”
Additionally, McMeekin said FDA is seeking new authorities around medical devices and clinical research or biomedical monitoring inspections. In those areas, she said, FDA currently has limited authority to request records and other information in advance, or in lieu of a physical facility inspection. Such authority exists for drugs and biologics facilities and proved very effective during the pandemic. The lack of this authority in other commodities has limited FDA's ability to make broader use of remote regulatory assessments during the pandemic. she added.