Since I am not a superhero and am unable to be in two places at once, I had to choose which of the afternoon sessions I would attend. With one of the hot topics being the inspectional issues raised by the COVID-19 pandemic, I chose to sit in on the Post-COVID Inspection World: New Tools, Lessons Learned and Future Challenges session.
There was a nice mix of FDAers and industry representatives providing their views on the nature of (and the challenges of) virtual inspections and alternate methods of inspectional evaluation. I will provide a brief review of the points that I consider to be the most salient issues discussed.
The toolbox for alternate methods including records reviews and virtual inspections has been filling up. Some things worked, some things did not. Folks from FDA indicated that it is critical for firms to understand the record review requests and to be able to provide appropriate records in a timely and well-organized manner. Failure to disclose all the relevant records, or to present deficient records can result in a delay which may also potentially delay action on an application.
The pandemic has created a backlog of inspections that must be dealt with. Virtual inspections may not be appropriate for most PAIs, or for Warning Letter follow up inspections, or where an import alert has been issued for a specific firm. FDA (along with industry) is learning what works and what does not. The potential for utilizing alternate inspectional tools after the pandemic also may decrease the FDA’s inspectional burden and, if the Agency decides it is appropriate to continue the use of an alternate inspectional tool, they will likely be applied on a risk-based basis and their use will depend on various elements specific to the firm (including previous inspectional history and the type of inspection required).
There is an obvious pressure from the industry and the FDA to meet application goal dates. Needing an inspection to take a final FDA action may impact meeting the User Fee goal. FDA acknowledges that the use of alternate methods may be useful; however, they also acknowledge there may be certain situations where that might not be appropriate. This, along with other issues, has a negative impact on the backlog of inspections that are required to be conducted. As the FDA looks at how to address the backlog, while keeping up with new assignments for inspections, the Agency may apply a hybrid approach. That is, a combination of various alternative means including use of other international regulatory body’s inspections, document review, and/or virtual inspections or there may be situation that just requires boots on the ground.
An additional issue that has increased the backlog concerns are the many products that may have been authorized through the EUA process where the facility or a contractor has not yet received an inspection, yet FDA exercised regulatory discretion due to the declared National Health Emergency.
There are continuing barriers for in-person inspection, including the status of COVID in certain countries, or what do you do when a firm reports before a scheduled inspection, that industry staff at the facility have recently tested positive. The question of how you protect both the FDA staff and industry personnel and further how does that potentially impact the quality of the drug product that individual may have been working on, or his fellow employees that have been exposed.
One of the questions in the Q&A session had to do with the Agency’s and industry’s views of how the future of inspections post-pandemic will be impacted based on the learnings and experience gained during the pandemic. Every one of the panel members agreed that it is likely that the alternate inspectional options and tools will become important in reducing the Agency inspectional load by permitting the FDA to perform more inspections and be able to better prioritize when inspections may need to have actual boots on the ground to support the Agency’s mission.