Voluntary remote regulatory assessments, plus a continued risk-based approach, are “efficiency” tools FDA is using as it clears through its inspection “backlog” resulting from the pandemic.
In July 2020, FDA resumed conducting select domestic facility inspections—inspections that the agency had entirely put on hold temporarily during the spring of 2020 as the COVID-19 pandemic took hold. This May, FDA released a report detailing how the pandemic impacted the agency’s inspectional work in 2020 and 2021, including an accounting of the number of facilities FDA has been able to inspect and its plan for prioritizing inspections as the pandemic continues.
During the American Herbal Product Association’s (AHPA; Silver Spring, MD) annual AHPA Botanical Congress, held virtually for the first time on May 24, Cara Welch, PhD, acting director of FDA’s Office of Dietary Supplement Programs (ODSP), explained what FDA's approach will be going forward for facility inspections for FDA-mandated products (such as foods and the subset of dietary supplements), including a continued reliance on remote and risk-based assessments when possible.
Remote Activities When Possible
Welch noted that many FDA staff, such as those not involved in lab research, are still teleworking, and that the agency’s existing online electronic submissions portals for new dietary ingredient notifications and structure-function claim notifications have worked well during the pandemic.
During the early days of the pandemic, the agency’s immediate priority was to ensure the safety and continuation of the U.S. food supply. Another priority was tracking and taking action against products—all types of products, not just dietary supplements—illegally claiming to treat or prevent illnesses like COVID-19. Welch said FDA “identified more than 1300 fraudulent and unproven medical products related to COVID-19” and “issued more than 170 warning letters, many involving our colleagues at the FTC, and thankfully seeing nearly 70% of the recipients taking steps to comply." This agency oversight continues. “We will continue to monitor the marketplace and take action when needed,” Welch said.
FDA has also been conducting what Welch called “voluntarily remote regulatory assessments (RRA).” These are not official inspections, and they are not mandatory. They are being conducted for domestic food establishments, including those for supplements.
As she explained: “An RRA is a voluntary program that allows FDA to request records that a firm is already obligated to maintain, and we review them electronically and provide our feedback. An RRA is initiated by FDA; you can’t request it. But a firm is not required to participate if we initiate one. It’s voluntary.”
Calling RRAs a “win-win” for both FDA and companies, she explained that a company has the benefit of having FDA review its records and compliance status, and has the opportunity to make any corrections before an actual inspection takes place. For FDA, RRAs allow the agency to better equip itself with information that will come in handy for future inspections. “We believe the RRA program offers an opportunity to use our resources more efficiently, particularly when a subsequent inspection is taking place,” Welch said. “For example, following an RRA, FDA should have a better idea of the type of operations being done at a particular facility, and then when a subsequent inspection is actually taking place, we will be better prepared, and it ultimately requires less time for the in-person inspection.”
In terms of Foreign Supplier Verification Programs (FSVP), inspections of foreign food suppliers to ensure they’re meeting FDA food safety standards, as mandated by the Food Safety Modernization Act (FSMA), have largely been conducted remotely.
The agency plans to continue performing remote inspections and assessments when possible, including for evaluating facility records. Said Welch: “I expect FDA will continue to utilize these remote assessments and inspections going forward even once the pandemic has ended, particularly as we are…looking for ways to be more efficient with our resources.”
The pandemic unsurprisingly limited the number of inspections, especially in-person inspections, that FDA was able to perform last year. In its aforementioned document, “Resiliency Roadmap for FDA Inspectional Oversight,” the agency reports that the bulk of FDA foreign and domestic inspections still uncompleted due to the pandemic are largely routine surveillance inspections, such as those assessing current good manufacturing practices (cGMPs).
The agency notes that it has planned to conduct 26,250 surveillance inspections in FY21, “reflecting those identified through our usual planning processes and criteria, and rolling over any remaining surveillance inspections postponed from FY20.”
The agency disclosed where it stands to date: “As of Mach 2021, FDA has inspected 2,953 of these firms by conducting some prioritized domestic inspections where and when it was safe to do so and leveraging our regulatory partnerships. With these completed surveillance inspections, FDA estimates 23,297 non-mission-critical surveillance inspections still to be conducted in FY21…Some of the remaining surveillance inspections will be conducted by our regulatory partners. However, if the agency’s partners are unable to conduct these inspections, FDA will be responsible for carrying them out.”
To handle the backlog, the agency said it will need to prioritize inspections. “The uncertainty created by the COVID-19 pandemic means that FDA will continue to conduct most mission-critical inspections and prioritized surveillance inspections; however, inspections that do not meet these criteria may be postponed due to the pandemic.”
Companies deemed lower-risk could also go a longer time between being inspected by FDA. In its document, FDA said that “mission-critical inspections will continue to be prioritized going forward. Routine surveillance inspections will continue to be conducted; however, the agency will prioritize higher-tiered needs. Thus, a longer interval between inspections will occur for lower-tiered inspection assignments as the agency adjusts to the impact of the COVID-19 pandemic. This means that postponed inspections will be prioritized on risk and conducted over a longer period of time, ultimately increasing the amount of time between inspections of certain lower-risk facilities.”
Efficiency Will Be the Name of the Game
In her presentation, Welch said that FDA will be looking for ways to increase efficiency as it not only deals with the “backlog” of inspections but also looks for ways to be more streamlined when possible moving forward. When asked whether practices like relying on remote inspections and focusing on risk-based areas will continue, she replied, “I think a lot of it will carry forward.”
She added: “Dietary supplements, of course, are foods, which fall under the FSMA mandate. The Food Safety Modernization Act has inspection mandates for food facilities. Every three to five years, you should be inspecting, [and] have a certain number of years to…inspect everyone. That’s going to be really hard, given 2020 and 2021. So, I think there’s a broader lens to look through as well: How can we be as efficient as possible? Which inspections do we need to prioritize? Which ones do we not need to prioritize? And there’s a whole lot that goes into that discussion. Thankfully, we have algorithms, we have the remote assessments, we have great people to look at that and figure out where is the best use of our inspectional resources as we are moving forward.”
When asked whether the agency has resumed unannounced inspections, Welch didn’t have a definitive answer. During the pandemic, she noted, “it was really in everyone’s best interest to preschedule them, which is outside of our process for domestic inspections. I believe that we are still in the posture of scheduling, unless for some reason we can’t do that—which I think we can all imagine a scenario or two when that happens.” But, she said, the issue of ramping up unannounced inspections is likely a topic of agency discussion.
In its document, FDA outlined two “best-case scenarios” for resuming inspections. The first would be an “immediate transition to standard operations” assuming “travel restrictions are lifted in all states and countries” and “no other emergency delays of prioritized work.” Under this scenario, FDA would have resumed standard operations this month, May 2021.
A more “gradual transition to standard operations” would see FDA “continuing progress toward resumption of standard operational levels by mid-summer 2021,” while still focusing on mission-critical and prioritized domestic inspections.
Of note, under either best-case scenario, FDA still estimates it would only be able to achieve a fraction of the domestic surveillance inspections it had planned for FY21.