FDA proposes rule changes to hold generic drug manufacturers accountable for injuries
The FDA has proposed new rules that would improve generic drug manufacturer accountability. More than 80 percent of prescriptions are for generic drugs. However, a gap in the law prevents those injured by a generic prescription drug from holding the manufacturers accountable in court. The proposed change would close this loophole.
Under the current rules, generic drug safety warnings must mirror their name brand counterparts. Last year, the Supreme Court ruled that generic drug makers cannot be held liable for injuries caused by their drugs because they have no control over their labels.
The Today Show investigated drug makers’ accountability in a special report last Friday. Reporter Jeff Rossen tells the story of Viola Purcell who contracted a neurological illness from taking a generic drug. The current FDA rules prevented her from holding the generic manufacturer accountable.
Watch her story below or read it here.
The new rules are open for comment for the next 60 days. You can help people like Viola by signing the Take Justice Back petition that urges the FDA to act quickly to restore justice for everyone who takes generic medication.
The petition is online here: https://www.change.org/petitions/keep-our-medicine-cabinets-safe