Generic drug makers may soon face tougher standards
Current legislation that protects generic drug manufacturers from liability lawsuits associated with the medications they sell, could soon be reversed. Though generic medications are supposed to be functionally equivalent to their brand-name counterparts, last year’s Supreme Court ruling stated that manufacturers of generic drugs would not be held liable for failing to warn about dangerous side effects, even when they are aware that patients have not been given adequate information about the risk.
Federal law requires only that generic drugs provide an exact duplicate of the label warnings of the name-brand mediation they are copying. However, Senator Patrick Leahy (D-VT) introduced a new bill to Congress on Wednesday that would hold generic drug manufacturers responsible for adding new warnings in order to make sure consumers receive proper information about the side effects of their drugs. The bill, supported by Democratic legislators in both houses of Congress, would authorize generic drug makers to revise their labels using the same processes currently used by brand-name drug manufacturers.
Opponents of the current law argue that it allows generic drug manufacturers to profit from the sale of dangerous medications that they know contain misleading warnings. In addition, hospitals and pharmacies are not required to warn patients that they are sacrificing their legal rights by taking the generic form. While consumers taking the name-brand version of a drug can pursue compensation through product liability lawsuits, those who are given generic brands have no case. As a result, an increasing amount of drug lawsuits throughout the country have been dismissed by trial courts, some of which include generic forms of Accutane, Reglan and Darvocet.
About the Author
Amy Sinclair is a Senior Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.