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Another loss for Novo

A federal judge has ruled against Novo Nordisk in a case the company made against a compounding pharmacy, concluding that the Danish drugmaker doesn’t have standing to make its claims — only the FDA can regulate and enforce the Food, Drug & Cosmetic Act.

Sound familiar? It should; it’s the second time in about a month that the company needed to be reminded of that fact. This time it was in its case against Wells Pharmacy Network.

Wells moved for summary judgement, pointing out a lesson Novo still hasn’t learned: Private parties can’t sue over the Food, Drug, and Cosmetic Act, and only the FDA has the right to enforce it.

Heck, we’ve been saying that for a while. Check out this slide from one of our presentations on the regulatory framework for compounding:

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