A shift on "pay for delay"--reopening doors for pharmaceutical competition?

by approved drugs is funded by the manufacturers — a situation that can lead to problems with the collection, analysis, and reporting of safety data.4 Finally, this alternative approach would be in keeping with a stronger, better-managed role for the FDA in monitoring drug side effects. A similar approach could also be used to create a fund for compensating patients injured by adverse events that are recognized only after a brand-name drug has lost its market exclusivity. Such a system could be structured like the one for vaccine-related injuries: to ensure a continued vaccine supply in the face of the liability exposure of vaccine manufacturers, Congress in 1986 created a no-fault system in which injured parties received compensation from a fund created by levying a small fee on each dose of vaccine administered. In the case of generic drugs, patients could qualify for similar compensation by demonstrating that they had been harmed by a generic-drug side effect that was not properly addressed in the label. Generics manufacturers that joined the program would bear additional liability only if their labels did not match the consensus version.5 It is unfair to patients injured by unanticipated adverse drug effects for their right to reparations to depend on whether they received a brand-name or generic version of the same medication, a choice that may have been entirely out of their control. The existing Pliva decision also removes incentives for generic-drug companies to perform pharmacovigilance and monitor lateemerging safety risks related to the products they make. Consideration of how questions of liability for generic drugs came to shape the industry — and our ability to think of drugs as generically interchangeable at all — can help us better achieve a low-cost, high-quality generic drug supply without suspending responsibility for studying and documenting drug safety and protecting patients.