United States Capitol Building - Washington, DC.

Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

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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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Gloved hand grabs beaker with rolled currency.

Rethinking Funding for Scientific Innovation

By Matthew Bauer

Academic science laboratories typically survive by applying for private- and government-funded grants. This model of funding scientific innovation is being flipped on its head with the creation of the Arc Institute in Palo Alto.

Research labs no longer need to apply for highly competitive processes for grants. Instead, the Arc Institute aims to put science first, by funding its scientific investigators’ salaries and research costs for 8 years.

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Doctors performing surgery.

The Need to Go Back to Basics in Patient Safety

By John Tingle and Amanda Cattini

In the hustle and bustle of our daily professional lives, it is sometimes all too easy to forget about the basics. In terms of health care practice and patient safety, these underpinning basic, foundational concepts include the need for proper patient communication strategies.

The consequences of failures in patient communication can be devastating. There is a need to go back to this basic issue at regular intervals.

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Female hand writing signature on the paper document.

How to Construct Better Organ Donation Policy and Achieve Health Equity

By James R. Jolin

The United States is facing an organ donation crisis, with massive gaps between supply and demand.

Per estimates from the Department of Health and Human Services (HHS), over 106,000 Americans are currently awaiting this life-saving medical treatment. Further, the burden of this shortage falls unequally:  in 2020, while approximately 48% of white patients in need of transplants received an organ, only 27% of Black patients secured one.

The stakes are too high to allow the organ donation crisis to proceed in the U.S. without bold intervention. But with many policy options on the table, unresolved ethical concerns, and a patchwork of organ donation laws across the country, the proper path forward is not immediately clear.

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Two women shaking hands.

An Empathetic Ear: Strategies for Employer Health and Wellness Negotiations

By Stacey Lee, Jacobo Guzman, and Gladys Johnson

Amid federal and state vaccine mandates, labor shortages, and increased requests for remote work flexibility, employers find themselves in an evolving landscape with less latitude over their organization’s workplace. As a result, employers and employees find themselves in conversations about crafting a “new normal” in which worker well-being is featured more prominently than before.

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Gavel and stethoscope.

Long COVID and Physical Reductionism

By Leslie Francis and Michael Ashley Stein

Like plaintiffs with other conditions lacking definitive physiological markers, long COVID plaintiffs seeking disability anti-discrimination law protections have confronted courts suspicious of their reports of symptoms and insistent on medical evidence in order for them to qualify as “disabled” and entitled to statutory protection.

We call this “physical reductionism” in disability determinations. Such physical reductionism is misguided for many reasons, including its failure to understand disability socially.

Ironically, these problems for plaintiffs may be traced to amendments to the Americans with Disabilities Act (ADA) that were intended to expand coverage for plaintiffs claiming disability discrimination. Three provisions of the Americans with Disabilities Act Amendments Act (ADAAA) are appearing especially problematic for long COVID patients in the courts.

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Person examining psilocybin mushrooms in lab.

Microdosing Under the Oregon Psilocybin Services Act: A Definite Maybe

By Dave Kopilak

In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.

The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.

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Group of athletic adult men and women performing sit up exercises to strengthen their core abdominal muscles at fitness training.

Exercise Equipment Advertisements and Consumer Distrust

By Jack Becker

Are you ready to learn about “the most innovative piece of exercise equipment ever”? To take advantage of “the momentum of gravity to target your entire midsection”? Doesn’t everybody want to “lose those love handles nobody loves”? To finally “have the flat washboard abs and the sexy v-shape [they’ve] always wanted”? Within “just weeks, not months,” anybody can “firm and flatten their stomach.” And “best of all, it’s fun and easy and takes just three minutes a day.”

Despite its endorsement from an expert fitness celebrity and customer testimonials, you might be skeptical of the Ab Circle Pro’s claims. After all, can you really cut out five minutes from the iconic 8-Minute Abs routine?

Massive and misleading promises are an unfortunate reality for many exercise equipment advertisements. Illegitimate advertising claims can harm consumers and impact overall consumer trust, which creates an uphill battle for honest companies. The Federal Trade Commission (FTC) already regulates exercise equipment, but supplementing its efforts with more consumer education and industry self-regulation could be a winning combination to restore trust in the fitness industry.

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Woman experiencing headache lying in bed in darkened room.

Small Doses of Psychedelics for Cluster Headaches

By Bob Wold

One understudied condition for which small doses of psychedelic substances such as psilocybin may be beneficial is cluster headache.

As founder and executive director of the advocacy group Clusterbusters, I have seen firsthand, as a patient and an activist, that, despite its modest name, cluster is far from “just” a headache. It is a chronic pain condition that lasts “on” and “off” for months or years, often with no hint as to its origin. Estimates suggest that one in 1,000 people – which equates to over 332,000 Americans – suffer from cluster headache.

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