Study: Updated regulations needed for generic drug labels


The report found, however, that at least 434 generic drugs no longer have a brand name counterpart.

At least 53 drugs approved by the FDA have required new warnings for serious or life-threatening risks in the last five years, according to the study.

“Generic drug manufacturers’ inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients,” said Michael Carome, director of Public Citizen’s health research group, in a statement.

The group says that use of generics has increased dramatically while FDA regulation has gone unchanged.

Generic drugs accounted for 80 percent of all prescription filled in the U.S. last year.

Public Citizen urges the FDA to allow drug producers to report updated safety information, both to ensure warnings are up to date and to correct a disparity in legal rights.

Under terms of a 2011 Supreme Court decision, a patient harmed by a generic drug with poor labeling cannot sue the manufacturer.