The Generic Drug Trilemma

More than 90% of prescriptions dispensed in the United States each year are for off-patent drugs. Yet the bulk of scholarship on prescription drug policy focuses on patented drugs. Discussions of prescription drugs are typically oriented around the “innovation-access dilemma”—the trade-off between stronger patent-based incentives for innovators and higher prices for purchasers of patented products. But for drugs in the “patent afterlife”—the period after patent protection and other forms of market exclusivity have expired—the innovation-access dilemma is not the fundamental policy trade-off. Higher prices do not necessarily redound to the benefit of innovators, and price is not the only significant impediment to access: drug shortages—often triggered by safety concerns—also prevent patients from obtaining the medicines they need.