Caleigh Propes

An article titled 'Politics, Science, and the Future of FDA Drug Regulation: FDA's Review of Mifepristone REMS as a Litmus Test' published online January 12, 2025, in JAMA. The article discusses the HHS's study on the safety of mifepristone.

💬 Editorial: FDA’s approach to regulating #mifepristone reflects a decade of cautious, science-led REMS decisions, with rare political input that has generally reinforced safety barriers.

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F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.

A study of FDA documents on mifepristone, an abortion pill, over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists, despite political pressure.

JAMA Health Forum presents a viewpoint article: "Gaps in US Psychedelic Policy and How to Close Them" by Caleigh Propes, Katherine Cheung, Matthew D. Eisenberg, et al., published online November 7, 2025.

Viewpoint: Rapid advances in psychedelic research and policy have created a patchwork of laws regulating access, marketing, and payment, leading to confusion, potential safety issues, and disparities in treatment. ja.ma/3Xqcsfu

New article published in
@jamahealthforum.com that examines and critiques 4 aspects of the current pathwork of regulations covering access to psychedelics––and then provides constructive, sensible, and actionable ways forward for each.

Work led by drug policy expert @caleighpropes.bsky.social

New today in JAMA Health Forum: Our team discusses how to fill policy gaps surrounding the use of psychedelics to treat mental health and substance use conditions, should they be approved by the US Food and Drug Administration.

Gaps in US Psychedelic Policy and How to Close Them This Viewpoint discusses how to fill policy gaps surrounding the use of psychedelics to treat mental health and substance use conditions, should they be approved by the US Food and Drug Administration...

Gaps in US Psychedelic Policy and How to Close Them | Health Policy - By @caleighpropes.bsky.social, @katherinecheung.bsky.social, Matthew Eisenberg, David Yaden | @jama.com Health Forum jamanetwork.com/journals/jam...

We'll be at PRIM&R later this week presenting a poster on this work. Stop by and chat if you'll be in Baltimore! (6/6)

We call on IRBs to revise their policies, recognizing the need for special ethical and regulatory protections when conducting research with pregnant people without resorting to language that casts aspersions on their capacity for decision making about research participation. (5/6)

We explored the extent to which IRBs have updated their policies to no longer characterize pregnant people as a "vulnerable" group, consistent with this change. We found that 72.9% of top research institutions in our sample (n=48) still described pregnant people as vulnerable. (4/6)

In the 2018 revisions to the Common Rule, pregnant people were removed from the list of "vulnerable" groups in response to longstanding scholarly critique about the need to recognize their capability to make informed decisions about their participation in research. (3/6)

Pregnant people have long been excluded from clinical trials — which has resulted in a critical evidence gap regarding the safe and effective delivery of their clinical care. This exclusion has also denied pregnant people potential benefits of research, and underrepresented their interests. (2/6)

Overdue: Delayed Revision of Institutional Review Board Policies Characterizing Pregnant Women After the Revised Common Rule | Annals of Internal Medicine

New paper thread 🧵 Out today in Annals of Internal Medicine, Stephanie Morain @bermaninstitute.bsky.social and I discuss the role of IRBs in facilitating appropriate inclusion of pregnant people in clinical research: www.acpjournals.org/doi/10.7326/... (1/6)

#ASBH25 - 3:45p PT | IRB Practices in Promoting Inclusion of Pregnant People in Research, Caleigh Propes | B119 asbh25.eventscribe.net/fsPopup.asp?...

Why We Know So Little About Medicines During Pregnancy Trump’s attacks on Tylenol come after decades in which many women were excluded from medical studies, which has created uncertainty about which drugs are safe.

"Too often, [Ruth] Faden told me, pregnant women are still viewed as fragile vessels who need to be sequestered from the world. 'We need to protect women through research, not from research,' she said."

Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been disc...

Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis - Katherine Cheung, Caleigh Propes, Marianna Graziosi, Kyle Patch, David Yaden | AJOB Empirical Bioethics www.tandfonline.com/doi/full/10....

The abrupt end of USAID-funded clinical trials is profoundly unethical USAID's stop-work order threatens to undo decades of progress in medical research ethics and cause harm to clinical trial participants.

Ruth Faden & Nancy Kass - The abrupt end of USAID-funded clinical trials is profoundly unethical: It’s also dangerous to the health of thousands of trial participants www.statnews.com/2025/02/16/u... via @statnews.com

"We have come a long way in preventing disease through vaccination, and we must not lose our progress."

This Viewpoint discusses the importance of early and continued vaccine use in the US.

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#MedSky

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Ethical considerations for sharing aggregate results from pragmatic clinical trials - Stephanie R Morain, Abigail Brickler, Joe Ali, Pearl O’Rourke, Kayte Spector-Bagdady, Benjamin Wilfond, Vasiliki Rahimzadeh, Caleigh Propes, Kayla Mehl, David Wendler journals.sagepub.com/doi/10.1177/...

Representativeness in Pragmatic Clinical Trials This JAMA Viewpoint explores the potential of pragmatic clinical trials to improve demographic representativeness and health equity in clinical research.

Untapped Potential? Representativeness in Pragmatic Clinical Trials | Research, Methods, Statistics - By Caleigh Propes, Kayla Mehl, & Stephanie R. Morain | JAMA jamanetwork.com/journals/jam...

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials by Caleigh Propes, Pearl O'Rourke, Stephanie Morain | Circulation: Cardiovascular Quality and Outcomes www.ahajournals.org/doi/full/10....