Comment by refurb

ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest.

And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.

Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.

I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez