Generic Drug Policy and Suboxone to Treat Opioid Use Disorder

Published in: The Journal of Law, Medicine & Ethics, Volume 47, Issue 4 supplement, pages 43–53 (December 2019). doi: 10.1177/1073110519898042

Posted on RAND.org on April 28, 2020

by Rebecca Lee Haffajee, Richard G. Frank

Read More

Access further information on this document at The Journal of Law

This article was published outside of RAND. The full text of the article can be found at the link above.

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone—including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses—helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.

Research conducted by

This report is part of the RAND Corporation external publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.