The Pandemic is Coming to an End, and so are the EUAs.
(Thursday, March 11, 2021)
Emergency Use Authorizations (EUAs) became a household term last year due to the Covid pandemic. Every single product to prevent, diagnose or treat the infection was cleared via the EUA pathway. But as the pandemic comes to an end, the Emergency Declaration that allowed the EUAs to exist will be terminated, making all the EUA products, unapproved products. In their announcements for EUAs, both the FDA and the media, rarely mentioned that the EUAs are intended to “temporarily” allow unapproved products to patients while the developers work through their regular market approval applications. The law tacitly allows the developers up to one year from the issue of the EUA to get full approval, and if the product is still not approved at that time, the FDA is required to provide “an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the FDA and the sponsor to overcome such obstacles”. This is very similar to the Complete Response Letters released at the rejection of market approval applications. If the product with an EUA also meets the criteria for the full approval, FDA can grant the full approval, but it is not automatic. With increased vaccinations, falling infection rates and deaths, and greater control on disease spread, the time for the termination of the Covid Emergency Declaration will be here soon, meaning all EUA products will need to either seek formal approval or withdraw from the market. While for the vaccines, it seems that the developers should be able to seek full approval based on the available information, the same is may not be true for the hundreds of Covid diagnostic tests, the masks, and other products. Many of these products may need to simply go off-market in the US at the termination of the EUA. That said, compared to regulators in most of the world, FDA had set a higher bar for granting EUAs for diagnostic tests, so it is possible that many of these EUAs may be able to get full approval without additional work, but that is to be seen. Another reason for several EUA products leaving the US could be the reduced demand for the diagnostic tests and PPEs, making it less attractive for the developers who jumped in the fray primarily to take advantage of the pandemic opportunity. While there may still be demand for point-of-care and home-use tests for the coronavirus, the same is probably not true for tests authorized only for CLIA labs. Similarly, many masks and other PPEs that have been exempt from market approval requirement during the emergency may prefer to leave the market rather than pursue expensive FDA approval. For now, all the EUA holders must start planning for the inevitable, i.e., transition from the EUA to the full approval by FDA for their products because soon we may have approved products or unapproved products, but no EUAs.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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