Gavel and stethoscope.

Eight Opportunities to Use the Law to Address Social Determinants of Health

By Jon Larsen and Sterling Johnson

Addressing the opioid crisis cannot stop at providing better access to treatment for opioid use disorder (OUD), expanding and enhancing harm reduction efforts, and reimagining the role of law enforcement, as explored previously in this blog series. The response must go further to make treatment and harm reduction more effective, by acknowledging the opioid epidemic as a reflection of the conditions of the whole society, identifying those conditions, and addressing them head-on. A whole-person response to OUD and other substance use disorders needs a well-coordinated whole-of-government response to address myriad societal issues that are critical to effective drug treatment, including, but not limited to, housing, education, economic development, and tax policy.   

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Disposable syringe isolated on black background.

Six Opportunities to Use the Law to Support Harm Reduction

By Jon Larsen and Sterling Johnson

Harm reduction in the context of the opioid crisis is focused on preventing overdose and infectious disease transmission by working with people who use drugs without moral judgment. Far too often, the public health imperative of harm reduction is blocked by federal policy, state laws, and other structural barriers anchored in the “war on drugs” that reduce the effectiveness of harm reduction efforts. To maximize the potential of harm reduction requires a whole-of-government approach, involving coordination across levels of government. 

As noted in this recent report, “Bringing the W-G approach to bear on a complex problem depends on several components, including agreement as to the problem, understanding the problem, and the causes of the problem. For many involved in government at all levels, the harm reduction challenge unfortunately falls at the first of those hurdles.”

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Judge's gavel, handcuffs and scales on grey background, flat lay with space for text. Criminal law concept.

Seven Opportunities to Use the Law to Address Drug Policing

By Jon Larsen and Sterling Johnson

There is a well-established whole of government response to drug policing centered around the “war on drugs.” However, the existing response is largely built on flawed policies that have resulted in mass incarceration, structural racism, and lagging improvements in treatment and harm reduction related to the opioid crisis. Policy changes must be considered to replace acknowledged failures and reimagine the whole of government response to drug policing. 

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of US drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). It ultimately provides a tool to address these misalignments directly. 

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Suboxone.

Five Opportunities to Use the Law to Address Persistent OUD Treatment Gaps 

By Jon Larsen and Sterling Johnson

People who need opioid use (OUD) treatment in the United States are often not receiving it — at least two million people with OUD are experiencing a treatment gap that prevents or hampers their ability to receive life-saving care and support. This reality reflects structural, policy, and legal misalignments common to the entire U.S. health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination.  

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of U.S. drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). It ultimately provides a tool to address these misalignments directly. 

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Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

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Hundred dollar bills rolled up in a pill bottle

To Address the Overdose Epidemic, Tackle Pharma Industry Influence

By Liza Vertinsky

A recently released government report estimates that 93,000 people died from drug overdose in 2020. This estimate reflects a jump in the death toll of almost 30% from 2019 to 2020, with opioids as a primary driver.

In response, President Biden has called for historic levels of funding for the treatment and prevention of addiction and drug overdose.

Transforming mental health and addiction services is a critical part of tackling the overdose crisis, but it is not enough, on its own, to address this epidemic, or to prevent a future one. We must also alter the conditions that fueled expanded use, and abuse, in the first place. As I argue in Pharmaceutical (Re)capture, a forthcoming article in the Yale Journal of Health Policy, Law and Ethics, this includes a change in how we regulate markets for prescription drugs.

To truly combat the epidemic, I suggest, we have to understand how pain became such a lucrative business and how regulators failed to protect the public health as the market for prescription opioids grew. Then, we need to put this understanding to work in the redesign of pharmaceutical regulation.

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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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two watercolor silhouettes.

Neurodiversity and Psychedelics Decriminalization

By Dustin Marlan

Following over fifty years of the racist and corrupt war on drugs, drug decriminalization is now a social justice issue. As I explore in Beyond Cannabis: Psychedelic Decriminalization and Social Justice, the decriminalization of psychedelic drugs, in particular, is a matter of diversity, equity, and inclusion.

Psychedelics have long been prohibited under Schedule I of the federal Controlled Substances Act. However, after successful efforts in Denver, Oakland, Santa Cruz, and Ann Arbor, there are now attempts underway to decriminalize psilocybin mushrooms and other natural psychedelics in over 100 cities across the country, including Washington, D.C., which will vote on Initiative 81 in November 2020.

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man lying on couch.

Psychedelics and America: A Digital Symposium

By Mason Marks

In 2020, the psychedelics research and policy reform renaissance is in full swing. Prohibited by federal law since the 1970s, psychedelic substances can alter how people see themselves, the world, and those around them. Clinical trials suggest they may help people overcome ingrained thought patterns associated with depression, anxiety, and addiction.

Acknowledging their spiritual and therapeutic potential, universities have established new psychedelics research programs. The Food and Drug Administration (FDA) has deemed them breakthrough therapies for depression and post-traumatic stress disorder. This designation means they could be significant improvements over traditional treatments such as selective serotonin reuptake inhibitors (SSRIs). Accordingly, the FDA has put some psychedelics on an accelerated course toward approval. Eventually, they could help millions who have not benefitted from existing therapies.

However, despite their breakthrough status, psychedelics will not become FDA approved for several years. Meanwhile, the COVID-19 pandemic is making the country’s mental health crisis worse. According to the Centers for Disease Control and Prevention, rates of depression, anxiety, substance use, and suicidal thoughts have risen in the past nine months.

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Large pile of amber prescription pill bottles

A Look at Florida’s Decade-Long Effort to Curb the Opioid Epidemic

By Jessica Lam and Megan Bershefsky

Over the years, Florida, an early hotspot in the opioid epidemic, has implemented a series of legal and regulatory responses that have been met with both success and continued challenges.

Since 2016 — about 25 years into an opioid crisis that began in the 1990s — more than half of the country has passed laws to limit either the number of days or the amount of opioids that can be prescribed. Florida is on the leading edge of both the epidemic and efforts to use law to combat its effects, passing its first laws before many other states.

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