Only 20% of people suffering from an opioid use disorder (OUD) receive treatment. The high cost and limited access prevent many from taking part in evidence-based treatment, and the prescription drug pricing contributes to the problem

In a perspective published in the New England Journal of Medicine, Rebecca L. Haffajee, JD, PhD, MPH, an assistant professor in the Department of Health Management and Policy at the University of Michigan and a researcher at the RAND Corporation and Richard Frank, PhD, the Margaret T. Morris Professor of Heath Economics, expose the behaviors of Reckitt Benckiser (now Indivior) that blocked generic competition that in turn limited access and affordability in the leading OUD treatment drug Suboxone.

Through “product hopping” –reformulating a brand name drug with additional or new benefits to insulate the brand from generic competition- Indivior managed to manipulate availability and prevent the widespread use of Suboxone generics. They continued by abusing the Food and Drug Administration Risk Evaluation and Mitigation System, filing questionable citizen petitions, and refusing to cooperate with generic manufacturers in safety strategies.

The high price of Suboxone that resulted limited the affordability of these drugs by state and local governments, budgeted providers of care and individuals households. By obscuring access to Suboxone, the manufacturer has earned at least $1 billion in extra profits.

Haffajee and Frank suggest that Congress reform the Orphan Drug Act and introduce more legislation to curb abuse in the prescription drug market. They also recommend modernizing the Hatch-Waxman Act to address the issue of product hopping, as well as modifying the filing procedures for citizen petitions.

This research was funded by Arnold Ventures.