A (sort of) OFA/FDA lawsuit update

What we know: The judge in the case of the Outsourcing Facilities Association against the FDA challenging the agency's resolution of the tirzepatide injection shortage has denied OFA’s motion for a preliminary injunction against the agency. And … that’s all we know; the ruling has been sealed, so until it’s unsealed, we can't know Judge Pittman's reasoning, nor the implications. The ruling doesn’t mean the case is settled, just that the FDA isn’t enjoined, i.e., it can take action as if the shortage is over while the case continues. 

So, does all compounding of tirzepatide copies by 503As stop immediately? (We’d say err on that side of things until you hear otherwise.) Will FDA announce an additional off-ramp? We’ve reached out to the agency with those question, so stay tuned.