I’m not sure Bate is arguing against generics in general. He seems to mainly arguing against importation of non-FDA-approved generics (and perhaps against drug re-importation in general). For example:

“Bate himself is agnostic: While he fears Obama will ‘open the market up to drugs approved somewhere but not by the FDA, I don’t know how realistic that concern will be.’”

I agree we shouldn’t open the US market to drugs that haven’t passed FDA scrutiny. I also agree it’s highly unlikely that Obama or anyone else would attempt such a thing. That Bate professes such concerns does seem to suggest unstated motives, but I’m not convinced he’s trying to denigrate generic drugs in general.

If that is his goal, he should probably avoid statements like this:

“Therefore it doesn’t surprise me when I hear some generic drugs aren’t up to standard. They’ll pass the basic tests, but are they bioequivalent? Will they release in the body at the right time at the right proportions? That’s a test you can only do in vivo, and [generic drug makers] may not be required to do those tests.”

Because the simple fact is that FDA-approved generics are required to do those tests, and they are bioequivalent. Perhaps you’re right that Bate doesn’t care about the accuracy of what he says, merely that he creates a cloud of doubt around generics. But if he’s really such a magician at all this, I’d expect him to raise concerns that are less easily dismissed.

Without some kind of proof that the FDA is intentionally acting more lax with respect to the guidelines of the generic drugs, I’d say it’s more likely the generics are cheaper mostly because they didn’t have to spend on the R&D and advertising that the original did. Making pills, by my understanding, is cheap and safe and efficient and accurate, regardless of who’s doing it, and I’d have to see extraordinary evidence to prove that the tolerances are not met as often with generics. Granted, generics may well HAVE a higher incidence of missing tolerance guidelines, but if they’re FDA-approved to begin with, that’ll get smacked down in a hurry, wouldn’t it?

That’s odd, since FDA is already the arbiter of safety and efficacy for all US drugs, branded and generic. They are the ones who set that ‘25% variation’ rule that your neurologist was concerned about. FDA is also quite aware of claims that drugs with narrow therapeutic ranges might require tighter standards. Yet even in those cases, FDA doesn’t typically require tighter limits (see Section VI.F at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf).

FDA clearly disagrees with Bate’s claim that many current generics are not “true copies of the well-produced drugs.” I don’t understand why Bate would think FDA is “friendly” to his position.