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Interestingly, federal law and FDA guidance are not mentioned in Novo’s legal briefs filed with the courts. Neither is the word “compounding.” Instead, the suits are filed under state deceptive practices laws for “manufacturing and selling unapproved new drugs.” (Interesting, that word choice “selling” – since what pharmacies do is “dispense” pursuant to a prescription.)
Reading the briefs, it’s as if Novo’s attorneys have no clue the Food, Drug & Cosmetic Act even exists. And therein may be their strategy: Basing the lawsuits on state law and – I presume? – hoping the court shares the plaintiff’s same amnesia about the FD&C Act.
If so, it’s a gamble on Novo’s part, especially in light of a Ninth Circuit Federal Court of Appeals case, Hope Medical Enterprises, Inc. v. Fagron Compounding Services, decided just this week. That case, in which on appeal the court ruled definitively in Fagron’s favor that the FD&C preempts state law, may provide some clues (and maybe some hope, no pun intended?) in how courts might view Novo’s case against the compounding pharmacies in the semaglutide cases.
As Novo’s arguments go, maybe there’s no “there” there?
We’ll see. For now, though, you may enjoy watching the attorneys’ arguments before a three-judge appeals panel in that Hope case.
Read on for more news.
– Scott
Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.
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