Abuses of FDA Regulatory Procedures

The Case of Suboxone

Published in: New England Journal of Medicine, Volume 382, Number 6, pages 496–498 (February 2020). doi: 10.1056/NEJMp1906680

by Rebecca Lee Haffajee, Richard G. Frank

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Only about 20% of the more than 2 million Americans with an opioid use disorder (OUD) receive treatment in a given year, much of which is not evidence-based. Buprenorphine, one of several medications used to treat OUD, substantially reduces the risk of overdose and can be delivered in office-based settings. Various barriers impede widespread access to buprenorphine, however, including federal requirements that clinicians obtain a waiver to prescribe it. In addition, high prices for brand-name buprenorphine formulations strain the budgets of public programs, which cover a disproportionately large share of people with OUD. In 2017, Medicare and Medicaid were responsible for 32% of the $2.58 billion in prescription buprenorphine sales. The bulk of these sales was for Suboxone, a patent-protected buprenorphine–naloxone sublingual film made by Reckitt Benckiser Pharmaceuticals (now separated from its former parent company and known as Indivior).

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