It is generally assumed that an FDA approval is conditioned on the demonstrated safety and effectiveness of a product. However, when the FDA authorizes the use of a product due to an emergency condition, does that mean that there is no requirement to demonstrate safety and effectiveness?

Presumably the FDA has some regulatory threshold between "not proven safe" and "proven safe" where it issues emergency use authorizations. So, to what degree are safety standards relaxed when an FDA Emergency Use Authorization is used in lieu of a standard FDA approval?

Second question: while it is obviously that the relaxation of standards is influenced by the severity of the emergency, but does that relaxation threshold also vary with political and or corporate pressures?

1 Answer 1


Looking on the FDA website, I found this:

Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19

In brief, it lays out that the Secretary of Health and Human Services is offering limited immunity from lawsuits and prosecution — at his considered discretion — for medicines and equipment to be used against the Covid-19 pandemic. It allows approved equipment and medicines to be used in 'off-label' or unapproved ways, and allows drugs that are being researched under 'investigative' exemptions, or even drugs or products that the Secretary decides could reasonably be on the market within 10 years (meaning drugs that are early in development, and not yet thoroughly tested). The FDA is still holding the reigns — it has the final say in determining that a drug or device is at least marginally safe — but it is setting aside the exhaustive testing and approval processes it normally requires before allowing general use.

Section IV to VI spell out what is and is not covered by this immunity during the Crisis, but it seems the standard being used is that the drug or device has a credible purpose in dealing with some aspect of Covid-19 and is not grossly or flagrantly irresponsible to use.

  • @ so the short answer is that the product is not known to be grossly or flagrantly irresponsible to use. As an added bonus, the govt is providing some immunity.
    – BobE
    Apr 1, 2020 at 4:28
  • 1
    @BobE: They are trying to open up options without compromising public safety excessively. It's a careful but problematic balance. Apr 1, 2020 at 4:49

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