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Generic Drug Policy and Suboxone to Treat Opioid Use Disorder

Published online by Cambridge University Press:  01 January 2021

Rebecca L. Haffajee  and
Richard G. Frank
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Abstract

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.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue S4: Current Topics in Health Law: Papers from the 2019 ASLME Health Law Professors Conference , Winter 2019 , pp. 43 - 53
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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