Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections.
Right now, the landscape is not pleasing to either FDA or the industry. High profile necessary products are likely one of the few exceptions when an inspection is needed. So, what is tomorrow going to bring? A lot depends on the tenor of the new administration relative to enforcement; however, the spigot is holding back a lot of enforcement activities as compliance staff cannot get to the sites for personal safety concerns for themselves ad the plant employees. When the spigot is turned back on, will the Agency drown in the firehose of a backlog?
While warning letters are still being issued, the question that I ask myself most often is how has the industry backslid without the watchful eye of the FDA on them? When the wolf gets back to the front door, what are they going to find? If history tells us anything, there will likely be a raft of enforcement actions boiling to the surface. It is suggested that firms begin checking the plumbing well before the inspections restart.
Another factor might be who is ultimately heading the FDA. Rumors are that Dr. Janet Woodcock may move from her acting role as FDA Commissioner into that position permanently. Dr. Woodcock has been fairly enforcement minded even in the more gentle and kinder FDA we see today. Her lead of the organization will certainly impact the direction enforcement activities will take. If she is not handed the reigns permanently, then who knows what side of the enforcement coin the FDA will be showing to industry. While it is “wait and see” right now, when the pandemic subsides, the direction the Agency will take will become all too obvious.
