“[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…”“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.”
— Sense Receptor (@SenseReceptor) December 6, 2023
In this clip from the same interview, Latypova describes how,… pic.twitter.com/kfdvDon6wL
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.”
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.”
