Category: Opioid Crisis

Suboxone.

Prior Authorization Insurance Requirements: A Barrier to Accessing Lifesaving Treatment for Opioid Use Disorder?

Temple University Center for Public Health Law Research Leave a comment

By Juan M. Hincapie-Castillo and Amie J. Goodin

Policies to mitigate the drug overdose crisis continue to fall short, as evidenced by increasing rates of opioid-involved overdoses and deaths in the United States. The COVID-19 pandemic has exacerbated this overdose crisis, and efforts are urgently needed to mitigate harm.

Individuals who have problematic opioid use are most frequently involved in opioid-involved overdoses, meaning that the use of a prescription opioid, or much more commonly a non-prescription opioid (such as non-medically sourced fentanyl or heroin), is used in a way that adversely affects the person’s life. Problematic opioid use may lead to a diagnosis of opioid use disorder (OUD). The medication buprenorphine has been proven to reduce opioid-involved overdose and harms and is one of few OUD treatments available as a prescription that can be dispensed by community pharmacies rather than from specialized facilities or specialty providers.

The federal government and several states have implemented strategies to improve and promote OUD treatment access, especially for the relatively inexpensive and effective medication buprenorphine. However, there are significant barriers that remain that preclude adequate and timely access to buprenorphine.

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Pill pack.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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Suboxone.

Eliminating Barriers to Opioid Use Disorder Treatment

Jennifer Oliva Leave a comment

By Jennifer D. Oliva, Taleed El-Sabawi, and Shelly Weizman

The tragedy of the ever-worsening drug poisoning and overdose crisis in the United States is compounded by a simple fact: We know how to prevent overdose deaths, and yet, the overwhelming majority of individuals with opioid use disorder (OUD) lack access to the lifesaving, standard of care treatment.

Research demonstrates that the opioid agonist medications methadone and buprenorphine are the safest and most effective treatments for OUD. As the National Academy of Sciences explained in a 2019 report, these two medications reduce risk of death by up to 50 percent and are associated with numerous other benefits, including improved quality of life, reduced rates of use of other opioids, and reduced risk of contracting illnesses including HIV and hepatitis C.

However, during the worst drug poisoning crisis in U.S. history, which is now killing more than 100,000 people a year, the country’s outdated and restrictive federal regulatory schemes that pertain to methadone and buprenorphine present a pernicious and persistent barrier to accessing OUD medications.

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Police car.

New Data Highlights Complexity of Good Samaritan Overdose Law Landscape

Temple University Center for Public Health Law Research Leave a comment

By David Momjian

Since 1999, over 800,000 people have died from a drug overdose in the United States, with more than half of those deaths (500,000) resulting from opioid overdose.

Additionally, all 50 states have experienced a spike in overdose deaths in the wake of the COVID-19 pandemic. In the 12-month period ending in May 2020, 81,000 drug overdose deaths occurred in the United States; the highest number of overdose deaths ever recorded in a 12-month period.

To combat the rising death toll from drug overdoses, 47 state legislatures and the District of Columbia have passed Good Samaritan laws (GSLs) to protect bystanders from criminal prosecution if they call for medical assistance during a drug overdose. Bystanders to a drug overdose are often worried that by calling for help, they could be arrested for drug possession or evicted by the police, who often arrive first at the scene of a 911 call, even if it is a medical emergency.

A new dataset built by the Center for Public Health Law Research at Temple University’s Beasley School of Law and funded by Vital Strategies, covers the evolution of GSLs in the United States from January 1, 2007, to June 1, 2021.

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Concept: An ounce of prevention is worth a pound of cure.

The Paradoxical Legal Treatment of Preventive Medicine

The Petrie-Flom Center Staff Leave a comment

By Doron Dorfman

Preventive medicine is a tool used by individual patients, primary care physicians, and governmental agencies to preempt illnesses rather than to treat them after they have arisen. Despite this salubrious aim, stigma, shame, and fear often are attached to the use of preventative care.

The stigma around preventive medicine can arise from the tendency to view such measures as a proxy for risky or otherwise socially marginalized behavior or lifestyle. Why would someone use a preventative measure if they are not at high risk as a consequence of their own choices?

Consider, for example, what I call “sexually charged” preventative health measures like the human papillomavirus vaccine or Pre-Exposure Prophylaxis (PrEP). PrEP is a highly effective daily drug regimen that prevents HIV infection, which has become specifically popular with gay and bisexual men.

As I discuss in a forthcoming paper, PrEP has been viewed by policymakers and health care professionals as a “license for promiscuity” due to the fear of risk compensation, meaning the adjustment of risky behavior by those who take PrEP to potentially have sex with more partners and with no condoms. Such views are reflected in Kelley v. Becerra, a case pending before the U.S. District Court of the Northern District of Texas, where plaintiffs wish to purchase insurance that excludes coverage for PrEP and contraception, to which they object to on religious and moral grounds.

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books

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Alexander Egilman, Aviva Wang, 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 August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.

A full posting of abstracts/summaries of these articles may be found on our website.

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police cars lined up.

Policing Public Health: Carceral-Logic Lessons from a Mid-Size City

The Petrie-Flom Center Staff Leave a comment

By Zain Lakhani, Alice Miller, Kayla Thomas, with Anna Wherry

When it comes to public health intervention in a contagion, policing remains a primary enforcement tool. And where a health state is intertwined with carceral logics, enforcement becomes coercive; emphasis is placed on the control of movement and behavior, rather than on support and care.

Our experience in New Haven during the first few months of the COVID-19 pandemic well illuminates this, while also revealing a logic of exceptional force lying dormant in municipal health practices.

Attending to the local is all the more important, albeit difficult, for fast moving and intensely quotidian practices, as COVID in the U.S. seems to be settling in as a pandemic of the local.

Our experience as activist-scholars working with a New Haven-based sex worker-led harm-reduction service and advocacy group, SWAN, suggests that by focusing on municipal practices, we can better understand what public health police power actually is. By orienting our scholarship toward the way social movements engage with local politics, we can then address how these police powers complicate the ability of those most at risk of both disease exposure and police abuse to engage with local authorities. Absent this engagement and critique, progressive policies for constructive state public health powers may be more vulnerable to attack from the right.

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Hundred dollar bills rolled up in a pill bottle

To Address the Overdose Epidemic, Tackle Pharma Industry Influence

The Petrie-Flom Center Staff Leave a comment

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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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

Chloe Reichel Leave a comment

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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a pill in place of a model globe

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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