Take Two: Just How Good Are Generic Meds Anyway?


A few days ago I wrote a post about generic painkillers and the fact that doctors themselves—who should know better—often don’t use them. “If physicians aren’t really sold on generics in their own personal lives,” I asked, “does this mean they’re not really sold on them in their professional lives too?”

Well, perhaps I got it backwards. A friend sent me a link to a Forbes article from last year about the FDA retracting its approval of a generic version of Wellbutrin:

The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no.

If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging; generics companies can sell such medications for a fraction of the cost of the originals because they don’t have to spend huge sums on drug development and marketing….But generic drugs diverge from the originals far more than most of us believe.

….The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.

In other words, physicians are becoming increasingly concerned about the reliability of prescription generics, so maybe they’re a little bit skeptical about over-the-counter generics too.

Now, I doubt that anyone seriously thinks this applies to aspirin or ibuprofen. There’s nothing proprietary about the formulas for these medications, and everyone knows how to make them just as well as the big guys. Still, I suppose it’s possible that a generalized uncertainty about generic prescription meds could translate into a bit of uncertainty about OTC meds too. And that little bit might be enough to make lots of doctors shrug their shoulders and plunk down an extra dollar or two for a name brand.

I’m just guessing here, of course. Mostly I just thought it was an interesting article and wanted to pass it along.

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