Regulating Methadone

• In Event: The Expansion of Health Policy and Public Health: Historical Perspectives

Abstract

Regulatory policies lay out a set of rules to be followed, typically creating binding restrictions on action with the goal of benefitting the public good. In this paper, we analyze the regulatory regime surrounding the use of Methadone as a medication-assisted treatment for opioid use disorder. We focus particularly on the politics surrounding the creation of federal regulations between 1970 and 1974, and the unusual regulatory scheme that emerged from this period. This regulatory scheme has significantly influenced responses to subsequent drug epidemics, including the contemporary opioid epidemic, and its history helps explain the contentious politics of medication assisted treatment, limitations to medication assisted treatment’s deployment, and the potential parameters for future policy changes.

From the 1920s through the mid-1960s, “maintenance” treatments for opioid users were viewed by federal officials as a form of narcotics trafficking, with criminal sanctions a potential consequence for physicians. During the mid-1960s, however, physicians identified Methadone as a potential treatment for opioid use disorder. A long-acting opioid agonist, Methadone can be used to stabilize patients. Early studies suggested that it may lead to reductions in crime, mortality, and other issues associated with opioid abuse. Federal officials embraced methadone maintenance as an approach to a new wave of heroin use during the late 1960s and early 1970s. Political pushback around the concept of “maintaining” users rather than seeking to “detoxify” them and concerns about diversion, however, helped to fuel the growth of a unique regulatory regime with important long-term consequences.

Methadone treatment, under rules grounded in the Controlled Substances Act and Narcotic Addict Treatment Act, falls under the auspices of the Food and Drug Administration and Drug Enforcement Administration. It is subject to a complex set of rules that limit availability and potentially stigmatize recipients. We analyze this regime relative to regulations for other pharmaceuticals categorized as controlled substances, relative to regulations surrounding newer approaches to medication assisted treatment like Buprenorphine and Naltrexone, and relative to the regulation of medication-assisted treatment in other nations. Lessons from this historical and comparative analysis about both drug politics and regulatory policy can inform understandings of contemporary efforts to address substance use disorders and also future policy reforms.

Authors

• Daniel Sledge, University of Texas, Arlington

• Herschel Nachlis, Dartmouth College