U.S. Capitol Building at Night

Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?

This post is an adaptation of an article published in the Harvard Social Impact Review.

By Allison M. Whelan

On June 24, 2022, the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, overruling almost fifty years of precedent established by Roe v. Wade and reaffirmed by Planned Parenthood v. Casey. The tragic consequences of Dobbs are many, and all require urgent attention.

Post-Dobbs, states have complete control over the regulation of abortion, including medication abortion. Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. As a result, the question of whether states can restrict or ban pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public

The consequences that result from state bans and restrictions on medication abortion reverberate across the U.S. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care.

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Empty hospital bed.

Do No Harm: A Call for Decarceration in Hospitals

By Zainab Ahmed

In an era of mass suffering, some still suffer more than others. What’s worse, there is nothing natural about it. It is human made.

As an emergency medicine resident at a large academic hospital in Los Angeles, I see how incarcerated patients’ suffering is sanctioned by hospitals and medical professionals, despite their pledge to do no harm.

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An armed guard surveys the grounds from the railing of a prison watchtower.

Surveying US Correctional Facilities’ Pandemic Policies on Medication for Opioid Use Disorder

By Laura Hannon and Alex Willhouse 

An estimated 65 percent of the United States prison population has an active substance use disorder (SUD). Providing comprehensive substance use treatment to incarcerated individuals has been shown to reduce both drug use and crime upon release. Treatment is a critical intervention to prevent opioid overdose deaths, which the CDC estimates increased by 15.4 percent, from 70,029 in 2020 to approximately 80,816 in 2021. Medications like methadone, buprenorphine, and naltrexone are an important part of a comprehensive approach to addressing opioid use disorder (OUD).  

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Suboxone.

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

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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

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

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

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

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva 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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