The U.S. Science and Technology 'Triple Threat': A Regulatory Treatment Plan for the Nation’s Addiction to Prescription Opioids

Abstract

According to the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), millions of U.S. citizens are addicted to opioids, drug overdose is the leading cause of death for Americans under the age of fifty, and the rate of opioid addiction is increasing faster than ever. Opioid prescriptions written in the U.S. now roughly equals the number of adults in the U.S. population, and U.S. sales of prescription opioids almost quadrupled from 1999 to 2014, though there was no reported change in pain. Four out of every five new heroin users first use prescription opioids, and physicians have been prescribing opioids without a sound knowledge base about them and addiction for decades.

The challenge of containing and reversing the U.S. opioid epidemic is ominous and, under the present law and policy scheme, overwhelming — as the CDC’s numbers reflect. Federal government entities, state governments, professional organizations, patient advocacy groups, and industry have acknowledged the crisis, and they are responding. Many have recognized the need to coordinate their efforts and to collaborate amongst themselves, but this simply is not enough. This article proposes that, to contain and reverse this amassing epidemic, the U.S. federal government must intervene in a decisive manner with centralized leadership, defined, tangible, and measurable objectives, sufficient and secured (established over a block of time, rather than subject to annual renewals) funding to enable accomplishing those objectives, and with full appreciation that time is of the essence. While the appropriation of $6 billion over two years under the Bipartisan Budget Act of 2018 is a direly needed boost in funding for opioid abuse and mental health treatment, this article proposes a coordinated project, problem-solving approach and a substantially more defined, directed, and substantial commitment. The article draws from the U.S. legacy of overcoming previous ominous challenges, including a threat to the very existence of democratic society, by advancing science and technology in such a manner through a government-academia-industry triple threat to the status quo.

Keywords: Opioids, Prescription Drug, FDA, Medical Profession, Technology Transfer, Drug Development, Pharmaceuticals, Drug Development, Research and Development, Public Health