In welcome news for patient advocates, the FDA plans to propose rule changes that would require manufacturers of generic drugs to warn patients if they learn of side-effects that doctors may not be aware of.
Currently, manufacturers of brand name drugs are required to immediately modify their product warnings if they receive important new information about risks or side effects. The FDA will then review the label and determine if the modifications are appropriate. If they are, then the manufacturers of generic versions must make similar changes to their labels. According to the United States Supreme Court, current FDA regulations require a generic drug label to have the exact same warnings as the brand name counterpart.
In contrast, the Supreme Court recently decided that generic drug manufacturers cannot be held liable for injuries caused by inadequate warnings because they are not permitted to make independent changes to their labels without first obtaining FDA approval. This places users of generics at risk of side effects that the manufacturer knows about, but the public and doctors may not; many side effects do not even become known until a product has been on the market for years, after adverse events are reported. By that time a brand name manufacturer may have stopped making its version and there would be no one required to immediately announce new warnings.
On July 3, 2013, the FDA announced that it will seek to amend the rules to allow generic drug manufacturers to change product labels without first having to wait for a brand name manufacturer to make a similar change. Immediate changes to generic drug warnings are likely to save innumerable lives. This may also lead to allowing patients to pursue lawsuits against generic drug companies. Currently, users of generic drugs are not able to sue for injuries caused by defectively designed drugs or inadequate warnings, even though users of brand name drugs can sue for the exact same problems. Under the rule change, generic manufacturers might have to modify their labels if they become aware of safety concerns, in which case they could be liable for failing to warn patients about new dangers.
The FDA will attempt to draft a proposed amendment by September of this year, at which point it will ask for comments from the public before taking the next step in the process.
