Insanitary subjectivity
As you’ll read below, APC recently filed an amicus brief on the side of an APC member pharmacy that was unfairly cited and threatened by the FDA. (I can hear your collective gasp, because we all know the agency would never do that! 😂)
In short, FDA was demanding that the pharmacy recall all of its non-sterile products because of “insanitary conditions.” Trouble was, what the agency was calling insanitary was completely subjective.
Now let me be very clear: Maintaining sanitary conditions is extraordinarily important. But so is having a definitive standard rooted in science and law. FDA seems to be taking the position that insanitary conditions are sort of like pornography: They know it when they see it. But that’s no way to regulate compounders, who deserve to have bright line definitions for maintaining compliance.
Another issue here is the agency’s strong-arming of compounders through threats and intimidation and without the benefit of due process or even sharing the details behind the rational for the strong-arming. The FDA can basically destroy a pharmacy’s reputation by issuing a press release that alleges insanitary conditions—and pharmacies know this, so they usually capitulate. But that’s not what happened this time, and compounders nationwide are the beneficiaries.
Thanks to Karla Palmer of Hyman, Phelps & McNamara, whom we engaged to write our amicus brief in this matter. And thanks to those of you who have contributed to APC’s Legal Action Fund, because that’s how we funded that legal brief.
Read on for details. I think you’ll be impressed—and glad that you’re a member of APC!
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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.
