Two companion bills in front of the New York State legislature would permit compounding pharmacists...
The song remains the same — and we know the tune by heart. Yet another court has reaffirmed the simple fact that you would think pharma companies would have comprehended by now: There’s no private right of action to enforce the Food, Drug, and Cosmetic Act. Only the FDA can do that.
In this case, it’s a victory for compounders (and patients) in Florida's Middle District. Danish pharma giant Novo Nordisk had sued tiny Brooksville Pharmaceuticals under the Florida Drug and Cosmetic Act, claiming — with little to no evidence — that Brookville’s compounded semaglutide presented a danger to patients.
The court dismissed the case because, with the shortage of Novo’s Ozempic and Wegovy now over, it’s the federal FD&C Act that’s applicable, thus only FDA can take enforcement action, not private companies. (There’s a case in Texas challenging that, for which APC has submitted an amicus brief, but it’s a long way from being resolved.)
Pharma companies have been tilting at this particular windmill for months now, and the result in court after court has been the same: They don’t have standing. Yet still they try … and still they strike out. Isn’t there a quote about what it means when you fail at the same thing over and over?
