The DTC microbiome testing industry needs more regulation.

Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm.

Clinical Algorithms, Antidiscrimination Laws, and Medical Device Regulation.

This Viewpoint discusses recent legal directives by the DHHS and FDA that could increase health care entities' liability for possible discriminatory biases of clinical algorithms and the need for additional legal clarity to avoid adverse effects on algorithm development and use.

The Woman Who Cried Pain: Do Sex-Based Disparities Still Exist in the Experience and Treatment of Pain?

Over twenty years have passed since JLME published "The Girl Who Cried Pain: A Bias Against Women in the Treatment of Pain." This article revisits the conclusions drawn in that piece and explores what we have learned in the last two decades regarding the experience of men and women who have chronic pain and whether women continue to be treated less aggressively for their pain than men.

Reciprocity and Liability Protections during the Covid-19 Pandemic.

During the Covid-19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical research to demonstrate that liability protections actually influence physician behavior, we argue that limited liability protections for health care professionals who follow established CSC plans may instead be justified by reliance on the principle of reciprocity. Expecting physicians to do something they know will harm their patients causes moral distress and suffering that may leave lasting scars. Limited liability shields are both appropriate and proportionate to the risk physicians are being asked to take in such circumstances. Under certain narrow circumstances, it remains unclear that the standard of care is sufficiently flexible to protect physicians from liability. Given this uncertainty, the likelihood that physicians would be sued for such an act, and their desire for such immunity, this limited protection is morally legitimate.

Getting Real: The Maryland Healthcare Ethics Committee Network's COVID-19 Working Group Debriefs Lessons Learned.

Responding to a major pandemic and planning for allocation of scarce resources (ASR) under crisis standards of care requires coordination and cooperation across federal, state and local governments in tandem with the larger societal infrastructure. Maryland remains one of the few states with no state-endorsed ASR plan, despite having a plan published in 2017 that was informed by public forums across the state. In this article, we review strengths and weaknesses of Maryland's response to COVID-19 and the role of the Maryland Healthcare Ethics Committee Network (MHECN) in bridging gaps in the state's response to prepare health care facilities for potential implementation of ASR plans. Identified "lessons learned" include: Deliberative Democracy Provided a Strong Foundation for Maryland's ASR Framework; Community Consensus is Informative, Not Normative; Hearing Community Voices Has Inherent Value; Lack of Transparency & Political Leadership Gaps Generate a Fragmented Response; Pandemic Politics Requires Diplomacy & Persistence; Strong Leadership is Needed to Avoid Implementing ASR … And to Plan for ASR; An Effective Pandemic Response Requires Coordination and Information-Sharing Beyond the Acute Care Hospital; and The Ability to Correct Course is Crucial: Reconsidering No-visitor Policies.

Probiotics and the Microbiome-How Can We Help Patients Make Sense of Probiotics?

The notion of probiotics as microbes that confer health benefits has its origins in the speculative ideas that are more than a century old, yet remain largely unsubstantiated by scientific evidence. The recent advances in microbiome science have highlighted the importance of intestinal microbes in human physiology and disease pathogenesis. These developments have provided a boost to the probiotics industry, which continues to experience exponential growth driven mainly by creative marketing. Consumers, patients, and most health care providers are not able to discern the underlying science or differentiate the permitted claims that promise vague health benefits from disease-specific claims reserved for drugs. No probiotic product has been able to satisfy the regulatory requirements to be categorized as a drug, a substance intended to cure, mitigate, or prevent disease. However, patients take probiotic products in the belief that they will help to treat their intestinal or systemic diseases. Thus far, the regulators have failed to create policies that would assist to inform the public in this area. In fact, the existing regulatory regime actually creates formidable barriers to research that could provide evidence for clinical efficacy of probiotic products. We propose a potential solution to this vexing problem, where a committee created through a partnership of academia, professional organizations, and industry, but free of potential conflicts of interest, would be charged with rigorous evaluation of specific probiotic products and the evidence in support of their different claims. Companies that would submit to this process would earn the trust of consumers and healthcare providers, as well as a distinction in the marketplace.

Vaginal Microbiota Transplantation: The Next Frontier.

The success of fecal microbiota transplantation (FMT) as a treatment for Clostrioides difficile infection (CDI) has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation (VMT) as "the next frontier" in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the recurrence of a condition referred to as bacterial vaginosis (BV). We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions.

The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.

Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies.

Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.

A proposed definition of microbiota transplantation for regulatory purposes.

The advent of fecal microbiota transplantation (FMT) and the prospect of other types of microbiota transplants (MT), e.g. vaginal, skin, oral and nasal, are challenging regulatory agencies. Although FDA is regulating FMT (as a biologic), there is currently no widely accepted or agreed upon scientific or legal definition of FMT or MT. The authors report on discussions regarding a definition of MT that took place among a working group of stakeholders convened under a National Institutes for Allergies and Infectious Diseases grant to address the regulation of MT. In arriving at a definition, the group considered the 1) nature of the material being transplanted; 2) degree of manipulation of the transferred materials prior to implantation; 3) ability to characterize the transplanted product using external techniques; and 4) origin of the stool product (single vs multiple donors).

Probiotics: achieving a better regulatory fit.

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few years. This article examines how the Food and Drug Administration and Federal Trade Commission currently regulate probiotics and makes recommendations as to changes that might be made to ensure that probiotic products are made available to the general public in a way that is both safe and effective.

Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project.

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a "reference catalogue" of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

Building public health law capacity at the local level.

Local health officials are called upon every day to implement the programs, enforce the regulations, and take the actions that protect the health of the citizens in their districts. These responsibilities and duties are created and regulated by a complex interplay of federal, state, and local law. Not only is an understanding of these laws necessary to carry out public health activities on a daily basis, but many public health scholars and practitioners also believe that the law can be used as a tool to take proactive steps to improve public health. Unfortunately, many local public health officials do not have access to the legal assistance they need to address the various legal questions that confront them. This deficit makes it harder for them to meet their day-to-day responsibilities and makes it much more difficult for them to use the law proactively as a method to improve public health in their communities. In addition, many of the attorneys who provide legal support to public health departments do not have the time or resources to develop a thorough and up-to-date understanding of public health law. This paper examines the experience of a number of local health offices in obtaining legal advice and of attorneys who provide legal advice and assistance to local health departments and assesses different models for organizing and financing the provision of legal services to local public health officials.