Circuit court accepts APC’s amicus brief

Good news from the 11th Circuit Court of Appeals. It accepted our amicus brief in Novo Nordisk’s lawsuit against three Florida pharmacies — Novo Nordisk v. Wellhealth/Wells/Live Well. 

If that case sounds vaguely familiar, it’s actually three cases that have been combined into one. And if two of those sound particularly familiar, that’s because Novo already lost those cases against Wells and against Live Well, but it’s now appealing. 

This combined case gets complicated quickly — and it’s why Mom always wanted you to be a lawyer. It’s not just about compounding; it touches on issues of states’ rights, and it hinges in part on the outcome of the Zyla case, which is currently before the Supreme Court. 

You see, Novo, a Danish company, wants US states to be able to enforce US federal laws as they see fit. Specifically, it wants states to be able to enforce the Food, Drug, and Cosmetic Act as it pertains to compounding. 

APC, on the other hand, believes it’s the FDA and only the FDA that should enforce the FDCA — not individual states. And courts have affirmed this again and again. 

A Fifth Circuit judge agreed with Novo in the Zyla case, apparently not because he cared about compounding, but because he wanted to set up a Supreme Court challenge rooted in ‘states rights:’ Think about Texas’s efforts to prohibit mifepristone … or to unilaterally enforce U.S. immigration law. Yeah, told you it gets complicated.

And if you’re wondering why Novo wants to get involved in an issue like states’ rights, we think the answer is simple: If states are allowed to enforce federal laws, drugmakers can (at least in theory) file the same anti-compounding lawsuits 50 separate times until they get the result they want.

“This court should not permit an end run around the ban on extraneous enforcement of the FDCA through state laws,” we wrote. Yes, states regulate pharmacies, but “[t]he extensive federal regulations governing compounding do not leave room for meddling by the states and private actors.” 

What’s next? The Eleventh Circuit Court has not set a date to hear oral arguments, but it may decide the case without one — especially considering Wells has asked SCOTUS to hear its Zyla appeal (no word from the court yet on whether it will, by the way). Bottom line: We don’t know what’s going to happen … but we’ll keep you informed.