Revise Generic Drug Labeling, Petition Urges
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.
- Antibiotic Overuse a 'Huge Threat' to Patient Safety, Says CDC
- CFO Exchange: Smartphones Poised to Disrupt Healthcare, Says Topol
- Consumerism Drives Healthcare Branding, Rebranding Efforts
- 3 Traits Personality Assessments Can't Reveal
- PA Ranks See 'Phenomenal Growth,' Lack of Diversity
- CHS Hacked, 4.5M Patient Records Compromised
- CFO Exchange: Healthcare Leaders Share 5 Innovative Ideas
- Business Roundup: M&A Activity Down Slightly in First Half of 2014
- Large Employers Trimming Healthcare Spending
- Carondelet to Pay $35M to Settle Fraud Allegations