LATYPOVA: ‘We can now have a non-investigational substance and use it in [a] non-medical and non-investigational way… That makes it [an] illicit drug.”

“Now we have this evolution, from expanded access use… where they said, ‘We can now have a non-investigational substance and use it in [a] non-medical and non-investigational way… That makes it [an] illicit drug.”

In this clip from the same interview, Latypova describes how,… pic.twitter.com/kfdvDon6wL

— Sense Receptor (@SenseReceptor) December 6, 2023

LATYPOVA:

“[W]hen you switch the status [of a regulatory pathway for a drug with the FDA]… to the non-investigational one [the EUA countermeasure pathway], the clinical trial becomes not a clinical trial—it’s just a collection of people trying drugs. Just like a recreational party…”

LATYPOVA:

The “first time the emergency use authorized thing came in was November 2003 through the National Defense Authorization Act, not through a bill that had to do with the FDA, or NIH, or public health, or anything like that.”

LATYPOVA:

The FDA lawyers said, in effect, “We want to violate the law, and we can’t, unless we design this new, extrajudicial pathway for ourselves.”