I believe that the answer to this question will be based on how a declaration of emergency, Prep Act, Project Bioshield, and other emergency statutes interact with the FDA act and other non-emergency statutes governing clinical trials. I believe that once the emergency is revoked, then the answer is probably yes. As long as the state of emergency is in effect then “medical countermeasures” such as testing, therapeutics, vaccines are regulated completely different than in normal times. Remdez would not exists in hospital but for the fact it is defined as a medical countermeasure per the Prep Act declaration. So who really understands?
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