POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

(Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.)

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!

Read More

Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Call for Submissions: Journal of Law and the Biosciences Special Issue on Abortion Law

American law on reproduction seems likely to change, perhaps radically, in 2022, as the U.S. Supreme Court considers challenges to state laws limiting abortion. In Dobbs v. Jackson Women’s Health Organization, the Court is considering a substantive Mississippi ban on almost all abortions after 15 weeks; in Whole Woman’s Health v. Jackson and United States v. Texas, the Court is considering the more procedural Texas “bounty hunter” statute for enforcing a ban on abortions after about five weeks.

In anticipation of the Court rulings on these cases, the Journal of Law and the Biosciences will publish a limited number of submissions as a two-part special issue on this general topic. The issue will focus on abortion law, but also include near-future issues for other human reproductive practices and technologies.

Read More

David Tolley headshot

Meet David Tolley, Petrie-Flom Center Advisory Board Member

The Petrie-Flom Center is excited to welcome David Tolley to our Advisory Board!

Tolley is a Partner at Latham & Watkins LLP and is the chair of the Litigation & Trial Department for the firm’s Boston office. He represents health care organizations in high stakes matters, including government investigations and litigation. Tolley has also worked on pro bono litigation with the Center for Health Law Policy Innovation at Harvard Law School to help secure access to life-saving therapies for people with hepatitis C.

To learn more about the depth of experience that Tolley will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The interview, which has been edited and condensed, follows.

Read More

Petrie-Flom Center student fellows 2021-2022.

Petrie-Flom Welcomes 2021-2022 Student Fellows

(Clockwise from top left: Matt Bauer, Jack Becker, Bailey Kennedy, Cathy Zhang, Leah Pierson, Kaitlynn Milvert)

We are so excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

Read More

Photograph of a stack of magazines on a chair

Impact of Journal of Law and the Biosciences Continues to Grow

The Journal of Law and Biosciences offers high-quality, open-access scholarship at the intersection of the biosciences and law. It is the first fully open-access, peer-reviewed legal journal to focus on these issues. The journal has international impact, with authors from across the globe vying for the opportunity to have their work published in the JLB.

Recently, the Journal of Law and the Biosciences received exciting news in the form of an updated impact factor score. The journal now has an impact factor of 3.583, a substantial increase from the year prior. It ranks #7 out of 151 law journals, an admirable position for the youngest journal included in the rankings. It is also second out of sixteen journals in the medical ethics category, as well as second out of seventeen journals in the legal medicine category.

In honor of this achievement, the Journal has compiled a list of the most impactful articles included in this calculation period.

The Journal continues to publish a wide variety of exciting new material. The most recent issue, which closed in June 2021, contains numerous articles from highly regarded scholars exploring hot-button issues in bioethics. The following excerpts offer a small preview of the wide breadth of analysis contained in the most recent edition.

Read More

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

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.

Read More

Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

Read More

Wade Ackerman.

Meet Wade Ackerman, Petrie-Flom Center Advisory Board Member

The Petrie-Flom Center is excited to welcome Wade Ackerman to our Advisory Board!

Ackerman is a partner in Covington’s FDA Regulatory group, where he advises companies and trade associations on complex Food and Drug Administration (FDA) issues. He also co-leads Covington’s multidisciplinary Digital Health Initiative, which advises clients who are using information technology and data to innovate and improve health.

To learn more about the expertise that Ackerman will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The conversation touches on a range of topics, from misconceptions about the FDA’s Emergency Use Authorization, to the promise that digital technologies hold in promoting health and wellness. The interview, which has been edited and condensed, follows.

Read More

Petrie-Flom Center logo.

Petrie-Flom Student Fellowship Now Accepting Applications

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship!

The Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics.

Read More

Petrie-Flom Center logo.

Call for Applications: Research Fellow for Diagnostic Digital Home Health

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time post-doctoral fellow to support its newly launched Diagnostic Digital Home Health initiative. This position will likely be a three year commitment.

This sponsored research project examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. This project will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship, with a focus on considerations of access and equity, social interconnectedness, and patient privacy.

Previous Petrie-Flom Center post-doctoral fellows have used their positions as successful launching pads for tenure-track legal, health policy, and bioethics academic careers. Our most recent post-doctoral fellow has published in leading journals such as JAMA, Science, and the Journal of Law and the Biosciences. She has been interviewed as an expert in biomedical regulation by media outlets such as Forbes and Lancet Digital Health and presented to regulators at the U.S. Department of Health and Human Services.
Read More