ANH members played a key role in thwarting efforts to eliminate access to personalized medicine. Two years ago, the FDA released a draft guidance saying that a compounding pharmacy (a pharmacy that makes customized medicines for individual patients) cannot register as both an “outsourcing” (503B) and a traditional (503A) facility. We issued an action alert to ANH members to speak out against this policy and submitted detailed legal comments drafted by our general counsel. The agency just released the final guidance, and the FDA listened to our criticisms. The bottom line is that this change will make it much easier for many compounding pharmacies to stay in business, meaning patients will be better able to get the medicines, such as nutrient IV infusions and bioidentical hormones like progesterone and estriol, that they need. This is an important victory.
FDA wants to act as your physician and regulate your access to customized medications. Action Alert! With its new guidance, the FDA is further tightening the screws on pharmacies that produce customized medications for individual patients. The agency is inserting itself into the role of “doctor” by deciding for patients whether there is a “clinical need” for certain medicines to be made at pharmacies. The reason? We believe they want to protect the monopoly of FDA-approved drugs. In its latest guidance, the FDA is signaling that it will further restrict the medicines that can be made at outsourcing pharmacies by adopting a stringent definition of “clinical need” if there is already an FDA-approved drug for a given condition.