In August, I wrote about the recent Supreme Court decisions shielding generic drug makers from accountability for injuries and deaths caused by their defective drugs. Because generic drug makers were required to use the same warning label as the brand name manufacturer, they were provided immunity for failing to warn of dangerous side effects. This meant that generic drug makers could sell their products without liability to consumers.
Justice requires that companies be held responsible for their dangerous and defective products. It is outrageous that a company could continue to market and sell a product for years with inadequate warnings, and yet, escape responsibility for the harm done. Yet, our courts have increasingly closed the courthouse doors to consumers.
It now appears that the FDA may act to remedy these bad legal decisions. On November 13, the FDA issued a proposed rule allowing generic drug makers to update their warning labels in light of new information.
Janet Woodcock, head of the FDA’s drug research and evaluation division, published an essay explaining the purpose of the new rule. Dr. Woodcock had this to say about the proposed new rule:
All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA
But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, …
The vast majority of prescription drugs dispensed in this country are generics. Yet, consumers who are injured by defective generic drugs are left with no justice. The proposed new rule may fix this injustice by placing responsibility on generic drug makers to warn of safety issues with their products.