Generic Liability Battle Shifts With FDA’s Labeling Rule Even As Some Court Issues Remain Unresolved
Teva attorney says forthcoming proposed rule to allow ANDA holders to change their labels raises host of questions; generic manufacturers have lost some cases alleging failure to update their label, which may lead to another Supreme Court review.
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Solicitor General notes that FDA is considering changing its regulations in an amicus brief in Mutual Pharmaceutical v. Bartlett; government says design defect claims against generic manufacturers are preempted by federal law in the case at hand but may be brought in other situations.
Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.
Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.