The Negative Outcomes of Pre-EUA: Lessons from COVID Antibody Tests
[Thursday, April 30, 2020]

The Emergency Use Authorization (EUA) is a very important tool for fighting special circumstances but the COVID-19 emergency has exposed that these can be exploited financially by bad players. Since the declaration of the emergency, FDA has relaxed several rules governing personal protection equipment (PPEs) and, more importantly, the diagnostic tests. A unique policy announced by the FDA on 16th March allowed serological tests that detect antibodies to the coronavirus to be marketed with just a notification to FDA of the intent to file an EUA, the Pre-EUA. Which meant someone could sell antibody-based diagnostics to patients with just an email to the FDA. The intent of the emergency policy was to allow developers to offer their tests to patients while working on their EUA applications and giving FDA time to review and formally authorize such tests. This would allow patients immediate access to tests which presumably would be eventually authorized by the FDA. It opened a floodgate for antibody diagnostic tests of all kinds, mostly imported from China, into the US for use in patients. In less than 6 weeks after the release of the specific guidance document describing the policy, FDA has received more than 230 such notifications, but so far issued EUAs to only 6-8 of these tests. There is no public record of the status of the EUA review of the rest of the 220+ tests currently sold to patients. On top, there have been concerns raised by the seller of these tests. First, there were numerous complaints of sellers claiming that their tests were “authorized” or “approved” by the FDA for sale in the US, which though technically true, since these tests were “allowed” by the FDA, led FDA to make public announcements to clarify that although FDA “does not object” to the sale of these tests to patients, it has “not authorized” the same. Don’t be surprised if you are confused by this statement, so are the consumers. At the same time, there have been numerous reports of several of these tests being found to be highly unreliable with unacceptable false negative levels and issues with validation data. At the same time, the manufacturers have been rapidly launching their tests to millions of users reaping the financial rewards. It is time for FDA to start holding the notifiers to higher standards and enforcing formal EUAs based on robust data analysis. Perhaps the need for quality tests is as important as the need for speed. Unreliable tests do not help the consumers. The FDA’s pre-EUA needs a new look to control the exploitation of patients.