Generics, Bioequivalence, and Justice

By Matthew L Baum

I have written previously on this blog about morally modifying technologies (here and here), which by definition work no better than existing technologies but enable the side-stepping of a moral tension associated with the first technology. Generic pharmaceuticals are a particularly well-known and widely endorsed form of morally modifying technology: they have no therapeutic advantage over name-brand drugs, but by costing less enable the sidestepping of some of the difficult moral issues involved in rationing healthcare.   With the current public focus on limiting the rising cost of healthcare, moreover, there is increasing emphasis on the development and use of generics as a cost-saving measure. Jonathan J. Darrow has already written on this blog questioning whether we should celebrate increasing public endorsement of the development of these drugs that bring with them no new therapeutic benefit. But I would like to highlight in this post a different challenge to the responsible pursuit of a golden age of generics: bioequivalence.

Helping the development costs of generics to stay low, the FDA has an abbreviated approvals process that hinges on the generic being shown ‘bioequivalent’ to the name-brand drug (on top of requiring the generic to contain the same active chemical and be taken by the same route and dosage form) [See here and here]. Bioequivalence may sound reasonable, but many would be surprised to learn that it does not mean therapeutic equivalence.

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