ACRA McMeekin Talks Up New Inspectional Affairs Council
FDA’s recently announced FDA Inspectional Affairs Council (FIAC), which will help plan and coordinate inspectional activities, is also intended to optimize the agency’s inspection program on an enterprise level, according to FDA associate commissioner for regulatory affairs Judy McMeekin. Delivering a keynote presentation at the Food and Drug Law Institute’s (FDLI) annual meeting 5/19, McMeekin provided additional information on FIAC’s role in shaping inspections as FDA transitions out of its pandemic response.
“I'm really excited about the FIAC because it is vital that we continue to take measures to ensure standards and the safety of food, drugs and the other products that we regulate are met,” McMeekin told the conference. “FDA is very large, it has multiple centers including ORA, and we're really trying to look at the inspection approach on an enterprise level including data infrastructure modernization. The FIAC will facilitate consistent use of tools and technologies and really provide additional flexibility to enhance data-driven, risk-based oversight modeling across the agency and the nation’s public health system.”
McMeekin also said that the council will 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 FIAC was announced earlier this month 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. FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the last year, as well as our plan moving forward.”
The report described the inspections that FDA was unable to complete during the past year due to Covid. From 3/2020 through 3/2021, FDA conducted 821 mission-critical inspections, including 29 in foreign countries, the report showed. It also conducted 777 prioritized domestic inspections since the resumption of that work in 7/2020. The agency says that of 13,500 applications for medical product approval or authorization received since 3/2020, an estimated 68 have been delayed due to the inability to conduct inspections, with most of them not mission-critical.
McMeekin told the conference that FDA has learned during the pandemic the inherent value in having multiple approaches available to assess quality compliance, and the need to develop tools which can provide additional regulatory information. Records requests in lieu of an FDA inspection became a much more mature program during the pandemic, leading to multiple Warning Letters and import alerts, according to McMeekin. “In programs where we do not have the explicit authority, including medical devices, tobacco, human and animal foods, we have established a process for conducting remote regulatory assessments or RRAs, and these are done to review information provided by a regulated establishment.
“In the spirit of learning from our experiences during the public health emergency,” she continued, “we’re evaluating how we can optimize our operations to ensure we are using our resources to the best effect possible. Remote interactive evaluations, a type of RRA, enable us to assess drug manufacturing and bio research monitoring establishments with interactive tools like pre-recorded or live stream video. We see remote interactive evaluations as part of a necessary strategy to evaluate medical product facilities by using all available approaches to ensure these products are safe, effective, and of high quality.” Last month, FDA released a guidance detailing the remote evaluations.
Asked to address cooperation and information sharing between international regulatory authorities, McMeekin said the pandemic has “definitely emphasized the need for collaboration and partnerships. It has been a vital part of our oversight to share established inspection reports from capable foreign regulatory authorities under the U.S.-EU mutual recognition agreements which really help inform decisions related to drug approvals and shortages, and I expect that this type of harmonization to continue and to strengthen.”