Regulation and the Opioid Epidemic

This is the first of a new weekly feature for The Regulatory Review, the “Saturday Seminar.” Each week, members of The Regulatory Review staff will highlight important or recent papers, reports, or commentary surrounding a focused regulatory topic. Each week’s Saturday Seminar will focus on a different topic.

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Nearly one in five people in the United States aged 12 and older used an illicit drug last year. Substance use imposes major costs on the public, including addiction treatment and prevention costs, losses in productivity, incidents of drug-affected driving, and increased mortality. In terms of mortality, opioid use is of particular concern: In 2017, more than two thirds of overdose deaths in the United States—some 130 deaths per day according to the Centers for Disease Control and Prevention—involved a prescription or illicit opioid. Despite these risks, providers continue to rely heavily on prescription opioids for pain management.

In light of these issues, how does regulation already address opioid use and addiction? How might it do a better job? The authors of the pieces featured in this week’s Saturday Seminar offer a variety of information and perspectives on these questions.

How Regulation Affects the Opioid Crisis

• In a paper published in the Food and Drug Law Institute’s Food and Drug Law Journal, Patricia J. Zettler of the Ohio State University Moritz College of Law, Margaret Foster Riley of the University of Virginia School of Law, and Aaron S. Kesselheim of Harvard Medical School argue that, because the oversight process for approving high-risk drugs like opioids does not take into account public health data, prescription opioids may be entering the market without adequate information on safety and efficacy. A summary of their paper was previously featured in The Regulatory Review.
• Writing for the Brookings Institution, Jennifer L. Doleac of Texas A&M University, Anita Mukherjee of the Wisconsin School of Business, and Molly Schnell of Northwestern University summarize research on state regulatory strategies for reducing opioid over-prescription, including qualitative prescribing limits, restrictions on so-called “doctor shopping,” and prescription drug monitoring programs. Based on their review of the literature, Doleac and her colleagues conclude that requiring prescribers to use prescription drug monitoring programs helps limit opioid prescriptions. This strategy, however, also appears to correlate with increased use of illicit opioids.
• In a recent article, Nina Feldman of WHYY explores the role of regulation in access to medication-assisted treatment. To prescribe buprenorphine—the gold standard of opioid-addiction care when used with therapy—providers in the United States need a waiver from the Substance Abuse and Mental Health Services Administration. Because providers must complete additional training to obtain this waiver and are initially capped in the number of patients they may treat, Feldman asserts that “many doctors don’t bother.” Feldman argues that this regulatory hurdle has contributed to inadequate access to buprenorphine.
• After comparing state naloxone access laws, Rahi Abouk of William Paterson University, Rosalie Liccardo Pacula of USC Sol Price School of Public Policy, and David Powell of RAND Corporation argue that only those laws that give pharmacists direct authority to provide naloxone “appear to be useful” in reducing fatal opioid overdoses. In contrast, laws that encourage naloxone use but prohibit pharmacists from dispensing it without a prescription have failed to reduce fatal opioid overdoses significantly.

Regulating Pain Treatment

• In a recent blog post, Francis S. Collins, director of the National Institutes of Health, analyzes the success of state-level developments to improve access to naloxone—a medication used to treat opioid overdoses—and argues that the United States “cannot solve the opioid addiction and overdose crisis without finding innovative new ways to treat pain.”
• Relying on a 2017 report commissioned by the U.S. Food and Drug Administration (FDA), a group of doctors and scholars argue that the perception, assessment, and treatment of pain must be considered in regulatory decisions involving opioids and recommend that FDA adopt a “public health framework to guide opioid approval, monitoring, and review.”

Safe Injection Sites and the Controlled Substances Act

• Safe injection sites have emerged as a harm-reduction tool to reduce overdose deaths and disease transmission among people who inject drugs. After a systematic review of the literature, some scholars conclude that supervised injection services appear to reduce fatal and non-fatal overdoses while increasing access to health services. Moreover, the authors assert that safe injection sites did not appear to increase drug use or trafficking.
• In a recent article for the Harm Reduction Journal, scholars argue that there is a “pressing need to create a more enabling environment” for safe injection sites by amending federal legislation. They further assert that permitting providers to assist in the injection process itself in a regulated setting may mitigate risks of infection, overdose, and drug-related violence.
• Writing for the Boston College Law Review, Alex Kreit of the Thomas Jefferson School of Law argues that a Controlled Substances Act (CSA) provision may allow states and localities to establish government-run safe injection sites. The provision immunizes state and local officials who violate federal drug laws in the course of “the enforcement of any law or municipal ordinance relating to controlled substances.”
• Last week, The Regulatory Review featured an essay about recent litigation over the legality of safe injection sites in Philadelphia. In United States v. Safehouse, a non-profit organization seeking to open a safe injection site argued that, by combining legal harm reduction measures endorsed by the U.S. Department of Health and Human Services and Centers for Disease Control and Prevention, safe injection sites may provide “lifesaving services” that comply with the CSA. The court agreed, giving credence to the notion that safe injection sites would not facilitate illicit drug use for the purposes of the CSA.