With the number of emergency use authorizations (EUAs) for drugs, devices, and biologics numbering in the hundreds and the relaxed enforcement policy on certain OTC products, the Agency will have a lot to do once the pandemic is over.
FDA will need to decide whether to grant final clearance or approval to a ton of products while removing the EUAs for products that have only temporary EUA status and for which the Agency will no longer permit deviations from normal procedures. That is a lot of work! Finalizing product approvals for vaccines, chasing down holders of temporary EUAs that will expire once the national Health Emergency (NHE) is declared over. This will require a boatload of manpower and may impact other enforcement actions or approval/clearance decisions the Agency is being swamped with.
It could also present a logistical problem as there are likely some players who never sought EUA for some products that are/were being marketed. These issues in combination with the backlog of inspections is likely to place an increased burden on FDA’s compliance staff. Winding down a national health emergency may be just about as difficult as the work that goes into declaring one and getting the necessary products onto the market as quickly as possible.
Another factor that could drag out the process is that once an NHE is declared, is that the Agency and the country are often fairly slow to rescind the emergency order. It is not like flipping a switch – now its over and everything goes back to normal. There are many tasks that need to be performed and as we all know, tasks take the FDA’s time. With the pandemic likely to be with us for at least another year or so, hopefully there will be products that are slowly removed from EUA status over time as the threat lessens. This next year may be just as crazy as the previous year. Hold onto your hats as we see which way the wind blows.
