On the recordSeptember 6, 2017
While I have great respect for my friend and colleague from Georgia, this misguided amendment would undermine FDA's work to enforce the critical patient safety protections that were passed in the Drug Quality and Security Act in response to a deadly fungal meningitis outbreak that killed 22 people in my home State of Michigan. Passing this amendment could ultimately lead to another crisis like what we saw. This amendment would prohibit the FDA from finalizing a draft memorandum of understanding that outlines when and in what quantity traditional compounding pharmacies can distribute compounded drugs across State lines. Hamstringing FDA's ability to ensure that interstate shipments are only made from pharmacies in States that are exercising oversight over that activity could create a gaping loophole and would turn back the clock to the days when bad actors like NECC were free to ship tainted products and murder people across the country without oversight. It is completely unacceptable. We should be standing up for the strong patient protections in DQSA rather than turning back the clock.
