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Prescription drugs are expensive. If you don’t believe us, go to the pharmacy and buy some yourself. Recent experiences, for example with AIDS drugs, have shown that the same drug often can be made for less money, and therefore sold for less money, if another company begins to make it. So why not do this routinely?
It depends on what you mean by “same.” The US Food and Drug Administration (FDA) Office of Generic Drugs states that “a generic drug is identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.”1 The FDA believes there is no evidence that a generic product manufactured to meet its specifications could not be used interchangeably with the corresponding brand-name drug.2 There are studies that support this position.3-9⇓⇓⇓⇓⇓⇓ However, a recent study10 (in a journal supplement sponsored by the manufacturer) showed that blood concentrations varied significantly between branded and generic clozapine in 40% of patients. A second study showed that psychosis recurred in 5 of 24 patients after switching to the generic formulation.11 Analogously, several articles have shown that substitution of generics for brand-name formulations of anticonvulsants can cause toxicity and breakthrough seizures.12-17⇓⇓⇓⇓⇓ Although the significance of such results are disputed by the FDA,18 the occurrence of such events is troubling, and underlines the importance of carefully determining when generics are acceptable because they are truly equivalent. For this reason, expert panels have discouraged generic substitution in the case of anticonvulsants.19-21⇓⇓
Two studies in this issue of Neurology suggest that loss of efficacy or …
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