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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Suboxone.

Obstacles and Advances to Accessing Medication for Opioid Use Disorder

By Marissa Schwartz

Medication for Opioid Use Disorder (MOUD), sometimes referred to as Medication-Assisted Treatment (MAT), is a life-saving, evidence-based treatment method considered the gold standard for addressing opioid use disorders. Unfortunately, however, there are a number of barriers — both legal and cultural — that prevent some patients from accessing the treatment they need.

MOUD combines the use of prescription medications (like buprenorphine, methadone, and naltrexone) with counseling and behavioral therapies to provide comprehensive treatment in an inpatient or outpatient setting.

Due to stigma toward MOUD from patients and providers, as well as an overall lack of providers certified to dispense MOUD, there are currently more prescribing rules in the U.S. for the drugs used in MOUD, like buprenorphine, than for opioids. Major legal barriers include provider limits on the number of patients to whom they can offer MOUD, restrictions on which facilities can provide in-patient MOUD treatment, and insurance pre-authorization requirements.

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Large pile of amber prescription pill bottles

How Policy Surveillance Might Help to Counter the Opioid Epidemic

By Erin Napoleon

In 2017, more than 47,000 people had died of an opioid overdose, and 2 million people were dependent on opioids. This astonishing number is attributable in part to the lack of federal and state legislation to curb the over-prescription of opioids.

Opioids first entered the US market in the late 1990s. Pharmaceutical companies’ assured physicians that opioids were less addictive than morphine and posed less dangerous side effects, and doctors began prescribing the pills at unprecedented rates.

Understanding how the dearth of federal and state legislation, coupled with prescribing patterns based on race and socioeconomic status, influence the over-prescription of opioids can potentially lead to new and innovative ways of solving the opioid epidemic that continuously threatens the United States.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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books

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

By Ameet Sarpatwari, Charlie Lee, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Close up of the Lady of Justice statue

The Privatization of Opioid Litigation

By Dan Aaron

As the opioid litigation continues over the shadow of one of our nation’s most pressing public health crises, some criticism has been levied at private lawyers representing the cities, counties, states, and individuals harmed by the crisis. For example, see the following tweet:

Let’s work out tax and healthcare financing policy county by county, with private lawyers taking a 25% cut every time. Judge Polster seems to like this idea.

The critiques are many, but can be summarized: (1) private lawyers are being enriched; (2) private lawyers are setting opioid policy; (3) private lawyers have misaligned incentives; and (4) private lawyers will not support public health.

Arguably, all these arguments bear some truth. However, do they suggest that the opioid litigation is incorrigibly tainted and tort litigation the improper avenue to address mass torts such as the opioid crisis?

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