[OA] Sarpatwari A, Sinha MS, Kesselheim AS. The Opioid Epidemic: Fixing a Broken Pharmaceutical Market. Harvard Law & Policy Review. 2017;11(2). http://harvardlpr.com/wp-content/uploads/2017/07/SarpatwariSinhaKesselheim.pdf
On September 16, 2016, President Obama issued a proclamation decrying the U.S. epidemic of opioid misuse and abuse. Describing opioid use disorders as “a disease that touches too many of our communities—big and small, urban and rural—and devastates families, all while straining the capacity of law enforcement and the health care system,” he called on Congress to provide $1.1 billion for improved access to treatment. The 21st Century Cures Act largely fulfilled that request. Passed by Congress and signed by President Obama in December 2016, the act issued one billion dollars to states for primary and secondary prevention measures over the next two years.
Such funding is sorely needed. The American Society of Addiction of Medicine estimates that over 2.5 million Americans now have an opioid use disorder. In 2015, 33,092 Americans died from an opioid-related overdose—a fourfold increase from 1999.
In addition to funding evidence-based measures to combat the worsening public health crisis, policymakers should probe the root causes of the overuse of opioids in the United States. Knowledge of these factors will help answer how the crisis could have been averted and, thus, how similar occurrences can be prevented.
In this article, we argue that non-rigorous patenting standards and ineffectual policing of both fraudulent marketing and anticompetitive actions played an important role in launching and prolonging the opioid epidemic.
We further show that these regulatory issues are not unique to prescription opioids but rather are reflective of the wider pharmaceutical market. We conclude by identifying practical ways in which the regulatory system can be reformed.
On September 16, 2016, President Obama issued a proclamation decrying the U.S. epidemic of opioid misuse and abuse. Describing opioid use disorders as “a disease that touches too many of our communities—big and small, urban and rural—and devastates families, all while straining the capacity of law enforcement and the health care system,” he called on Congress to provide $1.1 billion for improved access to treatment. The 21st Century Cures Act largely fulfilled that request. Passed by Congress and signed by President Obama in December 2016, the act issued one billion dollars to states for primary and secondary prevention measures over the next two years.
Such funding is sorely needed. The American Society of Addiction of Medicine estimates that over 2.5 million Americans now have an opioid use disorder. In 2015, 33,092 Americans died from an opioid-related overdose—a fourfold increase from 1999.
In addition to funding evidence-based measures to combat the worsening public health crisis, policymakers should probe the root causes of the overuse of opioids in the United States. Knowledge of these factors will help answer how the crisis could have been averted and, thus, how similar occurrences can be prevented.
In this article, we argue that non-rigorous patenting standards and ineffectual policing of both fraudulent marketing and anticompetitive actions played an important role in launching and prolonging the opioid epidemic.
We further show that these regulatory issues are not unique to prescription opioids but rather are reflective of the wider pharmaceutical market. We conclude by identifying practical ways in which the regulatory system can be reformed.
