OFA calls out FDA’s POV

In the ongoing legal case between the Outsourcing Facilities Association and the FDA, the agency submitted a brief that explains how it came to the conclusion that tirzepatide was out of shortage. The folks at the OFA realized that part of FDA’s logic was that the higher cost of FDA-approved tirzepatide would mean fewer patients could afford it so demand would drop.

As one of OFA’s attorneys wrote to us, “[T]hey knew the product was more expensive and knew patient access would be limited because of it and acted accordingly because they knew the demand would be less. So, much for wanting to lower drug prices and inflation costs [...] They knew this action would increase costs and did it anyway.”