Thanks to a Petition submitted by Public Citizen to the Food and Drug Administration (FDA), a change may be coming in generic drug labeling. At the present time, FDA regulations prohibit generic manufacturer’s from updating a product’s safety label too efficiently, creating a safety gap, as potential health risks may not be available to the public on a timely basis.
The new proposed rule would allow the safety information to be disclosed to the public while the FDA reviews the information. With the current rule, generic or prescription name brand drugs can be on the market for several years before serious safety hazards are discovered, leading to doubts about whether the amount of time a drug has been on the market has anything to do with the safety of the drug. Unfortunately, generic drugs, with lower prices, usually cause manufacturers to stop producing the name-brand drug, making the manufacturer less informed about the latest hazards of each drug.
In 2009, the Supreme Court issued a ruling which allowed people who are hurt by a brand-name drug to sue the manufacturer for damages. However, in June of 2013, the Supreme Court issued an opinion stating an injured person does not have the right to sue for damages caused by the design of a generic drug. Coupled with the 2011 Supreme Court decision that shielded generic manufacturers from lawsuits regarding improper labeling, an injured person has almost no recourse if the damages were caused by a generic drug. The one exception to the rule would be for a company that has a flaw in its manufacturing process. There is a small group of Senators who have proposed changing the FDA regulations so consumers are able to sue for damages caused by generic drugs. Unfortunately, due to the recent Supreme Court rulings, there is currently very little accountability for generic drug companies.
