• Rebecca L Haffajee and Richard G Frank.
• Rebecca L. Haffajee, J.D., Ph.D., M.P.H., is a Policy Researcher at RAND Corporation and an Adjunct Assistant Professor in the Department of Health Management and Policy at the University of Michigan. She received her J.D. from Harvard Law School, Cambridge, Massachusetts, and her M.P.H. from the Harvard T.H. Chan School of Public Health, Boston, Massachusetts, both in 2006. She received her Ph.D. in Health Policy (in evaluative sciences and statistics) from Harvard University, Cambridge, Massachusetts in 2016. Her research is focused in the behavioral health and pharmaceutical policy areas, evaluating policies such as mental health/substance use parity and laws intended to curb opioid addiction and misuse. Richard G. Frank, Ph.D., is the Margaret T. Morris Professor of Health Economics in the Department of Health Care Policy at Harvard Medical School. From 2009 to 2011, he served as the deputy assistant secretary for planning and evaluation at the U.S. Department of Health and Human Services (DHHS), directing the office of Disability, Aging and Long-Term Care Policy. From 2013 to 2014, he served as a Special Advisor to the Office of the Secretary at the DHHS, and from 2014 to 2016 he served as Assistant Secretary for Planning and Evaluation in the DHHS. His research is focused on the economics of mental health and substance abuse care, long-term care financing policy, health care competition, implementation of health reform and disability policy.
• J Law Med Ethics. 2019 Dec 1; 47 (4_suppl): 43-53.

AbstractDespite 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.

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