Missteps To Avoid In Marketing COVID-19 Antibody Tests

Missteps To Avoid In Marketing COVID-19 Antibody Tests

May 11, 2020

Article

Co-author, Law360, May 11, 2020

As the United States looks to reopen its economy and get Americans back to work, many have called for widespread COVID-19 antibody testing to determine who may previously have been exposed to the virus. In an effort to speed up this process, the U.S. Food and Drug Administration had until recently allowed private industry test developers to bypass the traditional FDA development and approval process and offer antibody tests so long as the developers make certain representations to the FDA and the public.

The FDA's apparent disinclination to regulate the onslaught of unapproved yet available antibody tests enabled antibody test developers to engage in outright fraud. This culminated in state attorneys general — including Colorado's — stepping up to stop the test developers' fraudulent marketing practices and the FDA ultimately reversing course.

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