FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by exabrial on Wednesday November 28, 2018 @03:41PM (#18555451)

The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular).

What you're referring to is the ability of a pharmacist to substitute one drug for another, if for instance it wasn't on your insurance's formulary (list of drugs they'll pay for). Drug A may be slightly different than Drug B, but the Drug B your insurance will pay for. Drug B might also _just happen to be_ a generic (because the pharmacist is trying to get your the best deal for your money). There's guidelines from the FDA, DEA, the state insurance commissioner, and state laws the pharmacists must be aware of so it varies greatly between states on what they're allowed to do. Made for a fun rules engine to implement in software.

Doctors can mark a prescription as DAW (Dispense As Written) which then the pharmacist can make 0 substitutions. Insurance companies aren't usually a fan of said doctors.

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Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by perl4ever on Wednesday November 28, 2018 @05:02PM (#18556101)

"The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular)."

Sometimes the FDA certifies a dosage of a generic based on a different dosage. This caused a problem not long ago when the dosage they assumed was fine didn't dissolve right, hence the absorbed dosage varied and was sometimes way too low. To add insult to injury, it was a psychotropic drug, so everyone assumed patients complaining were "just imagining things" for a long time.

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