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Putting Generic Drugs on an Equal Playing Field

Ennis & Ennis

06/21/2012 - New proposed legislation would allow generic prescription drug makers to update their labels. This would be a big change because it would open generic drug makers up to liability for inadequate warning and labeling. Currently only brand-name drug manufacturers can change drug labeling and the generic drug companies then have to mirror those changes.

Since generic drug manufacturers are banned from making label changes they are also immune to suits for failure to warn of adverse side effects. The bill proposed by Senators Leahy and Franken would give consumers the same legal rights that they would when suffering from negative side effects of a brand name drug.

If there is a negative effect that is not expressly noted in the labeling consumers of generic drugs currently have no rights to litigation. Since over 70% of prescriptions today are filled in generic form, according to the National Association of Attorneys General (NAAG), this puts many patients at risk.

Although there has been extensive research by the FDA before drugs are put on the market and the patent periods for brand name drugs do not allow generics to be manufactured until about seven to twelve years after the brand names drugs are introduced into the market many long term side effects are not discovered until later.

Consumers should not have to worry about the un-equal risk of taking a generic drug on top of worrying about how they are going to afford their prescriptions to begin with. The current process where generic drug makers can only recommend changes to the FDA is not conducive to promoting patient safety. Generic drug makers need to be liable for keeping safety information up to date to protect consumers as new concerns emerge.