A Unified System for Ensuring Drug Safety

Abstract

There are currently two systems in the United States to ensure the safety of pharmaceutical products: tort and regulation. The shared goal of tort law and Food and Drug Administrative (“FDAâ€) regulation is to make beneficial drugs available to patients while keeping unsafe drugs off the market. This goal will be better served if the two are combined into a unified system, wherein each functions in the role best suited to its relative strengths and weaknesses. In the proposed unified system FDA would be the decision maker, setting the standard for drug safety, and tort would be the enforcer, safeguarding the process of FDA regulation. FDA is the better institution for making scientific decisions on a society-wide basis. Tort is the better institution for ensuring FDA has all available information about a drug’s safety and for restraining undue political influence over FDA decision-making. Tort should therefore hold pharmaceutical manufacturers liable if they withhold safety information from FDA or if they attempt to force a decision on any basis except safety. Absent interference with FDA regulation, there is no need for tort liability. In these distinct roles, regulation and tort can each complement the decision-making of the other instead of overruling it. This shared governance of drug safety promises greater efficiency, less confusion, and ultimately more protection for patients.