By Jessica Wasserman, Esq.
This past week, five new EUA authorizations for serology tests were posted. The pace of authorizations has picked up — as has enforcement of claims and validation of test performance.
FDA Chembio EUA Revocation
The revocation this past week of the Chembio EUA for an antibody test is more serious than the Warning Letters. Chembio is the first EUA authorization that has been revoked based on failure of a test to validate through NCI. The Chembio test can no longer be distributed. Keep in mind that FDA will continue to work with Chembio if they choose to redesign the test and resubmit with new validation data—but during this time, the test is off the market. The revocation will likely impact the valuation of Chembio, it’s share price etc.
An open question is whether the test can be marketed for export. Outside the US, the FDA authorization is not required, of course. The test would need to meet the regulatory requirements of the country of import. However, some countries rely on the US FDA authorizations and the revocation could impact foreign sales.
FDA Warning Letters
FDA this week posted 3 Warning Letters to distributors making “at home use” claims. Test manufacturers should be sure to review the websites and social media of their distributors and educate their distributors about the disclaimer that is required on EUA notified and authorized tests. The tests should not claim they are diagnostic and should be clear that the tests are not approved, but only temporarily authorized under EUA or notified. The FDA recommended disclaimer is:
This test has not been reviewed by the FDA. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. FDA Warning Letters are in some ways not a big deal. The companies that receive the Warning Letters have a short time (48 hours) to respond to FDA and tell FDA: 1) what they have immediately done; 2) what they will shortly do to come into compliance. In this case, the distributors receiving the Warning Letters would notify FDA that they had changed their website to remove the at home claims. They would also assure FDA that they were in the process of reviewing all inventory; social media, etc. to fix any at home claims. FDA will check the website in a few weeks for compliance. If there are no problems, that should be the resolution of the matter.
It is important to understand that a company’s website and social media are its most significant vulnerability when it comes to claims. FDA does not have a large enforcement staff and reviews websites and social media as their main method of claims enforcement. Unless brought to their attention by a consumer or competitor, FDA does not otherwise generally police the marketplace for low risk devices.
The risk of the Warning Letters is largely reputational and FDA knows that Warning Letters can cause a problem for the companies receiving them, and that the publicity deters other companies and serves to educate consumers. FDA uses its bully pulpit as a way of enforcement because it has little resources or legal authorities otherwise. In order to follow through on threats of injunction and seizure, FDA would have to bring in the Department of Justice and this is very rare- usually reserved for really egregious life threatening non compliance.
FDA Warning Letter Announcement
FDA Chembio Serology Test EUA Revocation
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