The U.S. Food and Drug Administration should require manufacturers of generic drugs to promptly update warning labels when they learn of new side effects, the healthcare advocacy group Public Citizen said in a petition filed Monday.
At present, generic makers are prohibited by regulations from changing labels unless they have FDA approval, or unless the brand name maker has updated the label first.
But generic drug sales have skyrocketed, the group says, and their manufacturers have a wealth of information about issues related to effectiveness and safety. In fact, 90% of prescriptions for drugs with generic equivalents were filled with a generic rather than the brand-name drug, the group said.
"We think it's a really big regulatory gap that threatens the safety of drugs and therefore the safety of patients that generics can't update their warnings in the same way as brand name companies," argues Allison Zieve, director of Public Citizen's Litigation Group.
"Because of this, injured patients have no recourse and there's no one for them to hold accountable if, as happened in a case last spring, a patient was severely injured. The patients suffer in two ways."
According to the group's petition, rules say that responsibility falls on brand name manufacturers to re-label their products when they learn of potential harm, and generic makers to follow suit.