EUAs, Emergency Use Authorizations - Is it time for a "TIME OUT"?

November 25, 2020

I filed a Citizen Petition on EUAs with FDA today; it requests that FDA establish LIMITS on EUAs. While they have been the lifeline of bringing us COVID-19 tests & a host of COVID-19 treatments from remdesivir to maybe monoclonal antibodies & convalescent plasma against the coronavirus, there is no TIME LIMIT to these EUAs.

This puts the regulated industry in the position of profiting or at least charging for their R&D investment for the healthcare product. There is little incentive [or a reduced incentive] to proceed to get a full & complete FDA APPROVAL>they and their product are already in the marketplace!

A full & complete FDA REVIEW & APPROVAL [after an EUA is granted] does not necessarily change the manufacturer's cashflow>FDA APPROVAL does benefit consumers. It let's you know that the FDA has thoroughly evaluated all the submitted data and found the product both SAFE and EFFECTIVE. As we roll up our sleeves for the coming vaccination or watch the IV line for one of our sick friends or hospitalized family members, I believe that we all want the same thing> a SAFE and EFFECTIVE product. With only an EUA, we're not quite there, yet!

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