Recommendations for the Use of Behavioral Economic Demand as an Abuse Liability Assessment for Drug Scheduling

Before being marketed in the United States, novel drugs must undergo evaluation for abuse liability. Drugs with higher abuse liability are assigned a schedule associated with stricter regulatory controls. Behavioral economic demand techniques hold great potential for use as an abuse liability assessment in the scheduling of novel drugs. Advantages of demand analyses include (1) quantitative abuse liability results that allow for relative comparisons and ranking among drugs by abuse liability, (2) the ability to collect analogous measures of abuse liability in both preclinical and human clinical models, and (3) minimal extra work to add demand analyses to those analyses that are already recommended in Food and Drug Administration (FDA) guidance. Challenges primarily arise with the standardization of experimental protocols for such assessments, but these challenges may be resolvable with directed work to compare different methodological techniques. If successful, incorporation of these methods could help avoid scheduling errors that are costly to society.