Updated: June 19, 2020
The FDA has a new, easier-to-navigate web section dedicated to Emergency Use Authorizations (EUAs) for Medical Devices as part of COVID-19. This resource provides information on EUAs.
World Refugee Day 2020 is June 20, 2020. This year, the focus is on highlighting “the lives, the work and the societal contributions of refugees and migrants for a united response to a common public health threat: the COVID-19 pandemic”. Read more, here.
In today’s Recommendations for Industry, we further discuss how the ADA does not permit antibody tests.
With the number of warning letters issued to CBD companies for making health claims over the last few months, it seems that that “wild west attitude” is still prevalent, and even heightened by the COVID-19 pandemic. The FDA and FTC have issued 9 warning letters to CBD companies for selling fraudulent COVID-19 cures. Read more about what's happening!
In TAG’s May 2020 FSMA Fridays webinar, TAG President and CEO Dr. David Acheson MD and Senior Director, Regulatory and Scientific Affairs Dr. Ben Miller, Ph.D., MPH discussed Responsibly Reopening and Rebounding from COVID-19. Read more for an overview of the webinar where they cover COVID-19 testing, state-to-state return-to-work COVID-19 variations, and what it means to resume travel in this re-opening phase.
Recommendations for Industry
Antibody Testing Not ADA Permitted.
On June 17, the CDC updated its FAQs to state that employers cannot require COVID-19 antibody test results for employees to return to work. Because:
An antibody test constitutes a medical examination under the ADA; and
CDC’s Interim Guidelines state that a “should not be used to make decisions about returning persons to the workplace”;
Antibody tests do not meet the ADA’s “job-related and consistent with business necessity” standard for medical examinations or inquiries for current employees. Therefore, antibody tests cannot be required for employees to re-enter the workplace. Note: COVID-19 diagnostic viral tests to determine if someone has an active case of COVID-19 are permissible under the ADA.
Additionally, many questions remain as to the immunity conferred by a COVID-19 infection, particularly in those who are asymptomatic. A recent large-scale study out of China (currently under peer review) stated that out of a large number of healthcare providers participants believed to had been infected with COVID-19, very few had IgG antibodies, from which the authors concluded, “After SARS-CoV-2 infection, people are unlikely to produce long-lasting protective antibodies against this virus.”
Thus, in addition to the ADA restrictions, businesses should know what they will do with test results before implementing any testing. Give TAG a call for more information or assistance on testing recommendations and analyses.
As of June 19, 2020 (11:58 ET), there are over 8,527,000 cases (>454,000 deaths) worldwide.
Due to the increasing number of cases in the United States, TAG will move from reporting counts per country to focus on the United States, please see here for the data. For further information regarding worldwide numbers, please refer to John Hopkin University’s aggregate map.
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