Bioequivalence and narrow therapeutic index drugs

Every prescription written for a generic drug requires an act of faith by the prescriber that any one of the several available products will be therapeutically equivalent to the innovator (brand name) products. Concerns about this act of faith have been expressed for many years, particularly in the wake of the generic scandals that occurred in 1989-1990, and especially relative to the drugs with a narrow therapeutic range. We contend that these drugs are actually the least likely to pose problems in ensuring therapeutic equivalence, but that new criteria must be established for bioequivalence because the present system is wasteful and is stifling innovation in the industry. We propose four suggestions to the scientific and regulatory communities that we believe could assist in modifying the process such that innovation is encouraged and practitioners are reassured relative to the appropriateness of using generic drugs.