Let freedom—and dialogue— ring!
This weekend, America celebrates her birthday. We celebrate the shaking off bonds of despotism that bound us to a foreign government that treated our ancestors very unfairly. The cost of independence, of freedom, was—and continues to be—very high.
While we still all want absolute freedom and independence to do whatever we want to do—whenever we want to do it, of course—we also know that is not always realistic.
Sometimes we see the governmental agencies that oversee us as tyrannical despots who just want to crush our soul and rule over us like King George III ruled over the early American colonies.
The fact is, most government agencies have public health and well-being as their primary pledge. Do they over-reach sometimes? Of course they do! Do we need to push back sometimes? Yes, we do! Can we declare our independence from them? Well, no. We must work together to ensure we can continue to provide customized medications to our patients in a way that is consistent with public safety.
In the past, the FDA and compounding stakeholders have been so distrustful of one another that there has been very little dialogue. We have sat in our separate corners and have just prepared for battle with each another. Recently, through some hard work by APC, that has begun to change for the better.
The FDA’s Center for Veterinary Medicine and the Center for Drug Evaluation and Research have engaged APC in positive ways. We have made real progress communicating to and being understood by the agency on pain points that compounders face. I sense that FDA is actually listening and working to resolve some of those pain points. APC’s next meeting is on July 6 with CDER, and we are grateful for the opportunity to continue the dialogue on your behalf.
Have a happy Fourth of July! Remember what the holiday truly signifies. Take time to read the Declaration of Independence like I do every year. You can find it here.
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David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at [email protected].
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