Cuellar and Moolenaar question Hahn on MOU
In a March 11 congressional hearing, FDA Commissioner Stephen Hahn, M.D., provided new insight into FDA's current thinking on the long-awaited MOU on out-of-state shipments of compounded medications. In response to questions from House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration members Rep. Henry Cuellar (TX) and Rep. John Moolenaar (MI), Hahn said FDA was working on balancing the safety of compounding but not making it overly burdensome on states. "We want as many states as possible to sign this, and we understand access to compounded drugs is critical to some patients - and we do not want to deny that access - so finding the right balance between safety and getting those drugs to those patients will be important," Hahn said.
Hahn emphasized that FDA was aiming for a "balanced approach" to the MOU:
"We recognize that some patients rely on compounding specialized approach to get the medicines they need, on the other hand we are aware of safety issues and outbreaks that have occurred in the past we want to ensure supply and make sure it's safe as well is really important .... We are trying to streamline the processes around this to make it easier for compounders."
We're grateful to Congressmen Cuellar and Moolenaar for their support for pharmacy compounding and the patients you serve.
|