FDA Delays Ruling on Generic Labeling Save

The New York Times reports that the FDA has delayed its much anticipated ruling on generics until sometime in 2017. 

The anticipated ruling would require generic drug makers to be more responsible for the side effects and risks associated with generic products. Under the current law, the responsibility for safety and warnings rests with the manufacturer of the brand-labeled drug, creating a legal loophole that prevents patients harmed by generic drugs from suing generic manufacturers.

The delay has led to protests by citizen safety groups and lawyers, but is supported by the generic manufacturers and their lobbyists, who believe this gives the FDA more time to consider the proposed changes.

In 2011, the Supreme Court ruled generic drug makers could not be held liable for failing to warn patients about the risks of their products because the generic companies had no control over what the warning labels said. Thus, the public safety responsibility rested with the trade drug manufacturer, even after the patent expiration date. 

Changes in this rule have been under consideration at the FDA since 2013.  The FDA has proposed changing the rules to require both generic and brand-name drug makers to update their labels as the product safety profile changes over time. This could potentially lead to many different safety labels for the same drug - the brand name drug and all its generics. 

Other alternatives to this ruling have been proposed and are being considered by the FDA.