It's time to talk
Is the FDA friend or foe? While it may never be the former, APC is working hard to ensure it is not the latter.
I admit I have long viewed the FDA as an adversarial agency trying to keep us from helping our patients and possibly trying to shut down my compounding pharmacy. This became much more pronounced after the NECC tragedy.
Whatever sentiment we each feel for the FDA, we need to face facts: It is a huge government agency that holds a lot of power over pharmacy compounding. We can stand on our soap boxes and shake our fists proclaiming that section 503A of the Food, Drug and Cosmetic Act leaves the practice of compounding pharmacy to the states and not the federal government (any of us who have experienced an FDA inspection know that line is blurry, at best).
It looks like we are on opposite sides of the fence, but we are actually walking down the same path: We—FDA and compounding pharmacies—all want our compounds to promote patient safety and to be efficacious. We work hard to ensure this, and the FDA does, too.
This shared focus is a mutual space for us to work together in the interest of our patients.
In recent years, APC has been working to establish a respectful relationship with the FDA. We have extensively engaged the agency’s Center for Veterinary Medicine, and our input is being heard. We are working with them to delay and revise the flawed GFI 256 for animal compounding. We are also engaged with the FDA CDER’s Office of Compounding Quality on several issues, including MOU implementation, clearer definitions of “insanitary conditions,” and urging the agency to slow down on restricting compounded hormones.
Because of the relationship we’ve built thus far, FDA's Office of Compounding Quality and Compliance Director Gail Bormel has agreed to join us for an interview with our CEO Scott Brunner at Compounders on Capitol Hill on September 14. This is a don’t-miss session and the perfect opportunity for us to communicate our positions with passion and credibility.
We can continue to argue, sue and counter-sue ad infinitum, but these aren’t always productive, and they require extraordinary resources that we don’t always have. I implore you to please put personal grievances aside and join us in a dialogue with the FDA with our patients’ health in mind. We may just make some progress.
I look forward to seeing all of you at CCH in Washington September 14-15. If you have not yet registered, here’s where to do that—for your business and your patients.
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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 drdave@keystonepharm.com.
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