A woman walks into a pharmacy to fill a prescription. She is offered either premium-priced drug Brand Name-X or Generic Drug Y, which offers the same treatment at a significantly lower price. She understandably chooses Generic Drug Y. She is not alone, as more than 75 percent of all prescriptions are filled by generic versions of drugs, largely because states require generic substitution which lower health care costs. But many patients are unaware of the lack of accountability that generic drug manufacturers have to warn of safety risks associated with their products.
The manufacturers are not entirely to blame. The federal oversight agency, the Food and Drug Administration (FDA), has created regulatory obstacles preventing manufacturers from adequately warning patients when the manufacturers become aware of potential hazards associated with their products that are not currently addressed on the generic drugs’ labeling. Second, and compounding this safety problem, patients harmed by generic drugs are barred from suing manufacturers of generic drugs. The result is a significant gap in generic drug safety and manufacturer accountability.
In August 2011, Public Citizen submitted a citizen petition (PDF) to the FDA urging it to address the problem. The petition asked the agency to amend its regulations so that manufacturers of generic drugs could revise their products’ labeling to add new information about risks and contraindications, through a revision process currently permitted only for brand-name drug manufacturers.
As experts have noted, all the risks associated with a particular medication are not identifiable until after the product has been on the market for several years. In addition, the majority of approved drugs with distinct ingredients, delivery routes, and strengths are available in generic form. In fact, many drugs are available solely in generic form. Because of their expanding market share, generic drug manufacturers likely receive substantial reports of safety incidents, and have the tools to be fully aware of information suggesting previously unknown risks or other inadequacies in the current labeling.
Unfortunately, the FDA’s failure to keep regulations in pace with the growth of the generic drug market creates a gap in drug safety.
Financial Protection Bureau be gutted. That’s the hallmark of the Dodd-Frank law approved by Congress to prevent predatory lending, liar loans and the other abuses behind the housing bubble—and our subsequent Great Recession.
