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Much of the analysis of the public health legal and regulatory mechanisms that potentially apply to biomedical citizen science activities in the United States has focused on the federal government, including US Food & Drug Administration (FDA) and human subjects research requirements. But US state governments have authorities that intersect with, and sometimes extend beyond, federal regulators’ powers—such as through state medical practice statutes—and these state authorities might reach certain biomedical citizen science activities. For example, in 2019, California both enacted a “CRISPR law” requiring sellers of gene therapy kits to inform consumers that such kits “are not for self-administration,” and through its Department of Consumer Affairs, launched an investigation of a well-known biohacker for “unlicensed practice of medicine” under existing law.Building on legal analyses of state efforts to regulate establishment science, this essay explores ways that state governments might regulate biomedical citizen science activities and associated bodily autonomy—something that states may become increasingly interested in as biomedical citizen science efforts proliferate and intersect with state efforts to regulate bodily autonomy (for example, in the context of abortion). It also explores implications for those engaged in biomedical citizen science, including the fact that even when state regulatory efforts are not enforced or are successfully challenged, they are important because they can still influence federal policy.

A Divisive Ruling on Devices The FDA has long taken the legal position that regulated devices could also be categorized as drugs. But according to a recent case, products meeting the definition of ...

Hospital exemption (HE) is a regulated pathway that allows the use of advanced therapy medicinal products (ATMPs) within the European Union (EU) under restrictive conditions overseen by national medicine agencies. In some EU countries, HE is granted for ATMPs with no demonstrated safety and efficacy; therefore, they are equivalent to investigational drugs. In other countries, HE is granted for ATMPs with demonstrated quality, safety and efficacy and for which centralized marketing authorization has not been requested. The Committee on the Ethics of Cell and Gene Therapy of the International Society for Cell & Gene Therapy reflects here on the ethical issues concerning HE application from the perspective of the patient, including risk-benefit balance, accessibility and transparency, while providing evidence that HE must not be regarded as a conduit for unproven and unethical ATMP-based interventions. Indeed, HE represents a legal instrument under which a patient's need for access to novel ATMPs is reconciled with ethics. Moreover, for some unmet medical needs, HE is the only pathway for accessing innovative ATMPs. Nonetheless, HE harmonization across EU Member States and limitations of ATMP use under the HE rule when similar products have already been granted centralized marketing authorization to avoid a parallel regulatory pathway are controversial issues whose political and economic consequences are beyond the scope of this review. Finally, the institution of an EU registry of HE applications and outcomes represents a priority to improve transparency, reduce patient risks, increase efficiency of health systems, facilitate company awareness of business opportunities and boost progressive entry of ATMPs into the therapeutic repertoire of health systems.

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child’s pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children

FDA generally regulates products containing nicotine under its tobacco authorities, unless those products are intended for smoking cessation—in which case, they are regulated as drugs that must be FDA-approved as safe and effective. Accordingly, for e-cigarettes, questions arise about where the line is between a tobacco product intended merely for recreational use and a drug product intended for smoking cessation. Against this background, this Research Letter describes a content analysis of certain claims made by 28 online e-cigarette retailers and argues that our findings suggest a need for additional regulatory clarity about when e-cigarettes are appropriately regulated as smoking cessation drug-delivery devices rather than tobacco products.

Summary The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here., The updated Guidelines for Stem Cell Research and Clinical Translation describe the ethical principles and best practices for basic, translational, and clinical research involving stem cells and human embryos. The updated Guidelines include new recommendations to address the recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.

The speed and scale of the COVID-19 pandemic has highlighted the limits of current health systems and the potential promise of non-establishment research such as "DIY" research. We consider one example of how DIY research is responding to the pandemic, discuss the challenges faced by DIY research more generally, and suggest that a "trust architecture" should be developed now to contribute to successful future DIY efforts.

BackgroundIn January 2019, electronic nicotine delivery systems (ENDS) market leader Juul Labs (JUUL) launched an advertising campaign encouraging adult smokers to ‘make the switch’ from combustible cigarettes to JUUL. Our primary aim was to describe consumer perceptions of JUUL as communicated by members of JUUL’s online social community via testimonials promoted on JUUL’s website.MethodsUser testimonials that were displayed on the JUUL website in December 2019 and January 2020 were collected and coded by three reviewers. A total of 220 testimonials were coded for primary and secondary themes (eight codes within four broader themes).ResultsTestimonial writers were, on average, 43.0 years old (range 28 to 74) and reported using JUUL for an average of 21.8 months (range 9 to 59 months). The most prominent theme, present in nearly half of the testimonials, was a description of how to use JUUL, with a mention of JUUL’s benefits and tips on how to use the product. Nearly four in 10 statements encouraged smokers to give JUUL a try or noted that JUUL is a better product compared with cigarettes. About one in 10 statements focused on switching from smoking cigarettes to using JUUL.ConclusionThis study presents a foundation for understanding how adult users describe JUUL, including their experiences using JUUL to ‘switch’ or stop smoking. Currently, the effectiveness of ENDS for smoking cessation is not supported by substantial evidence; however, if cessation is defined as ‘quitting combustible tobacco products’, then regulators should be aware that switch and cessation messages may not be distinct.

This chapter provides an overview of medical products law. Policymakers around the world have long recognized the need to regulate medical products, meaning interventions intended to prevent, diagnose, treat, or cure diseases and other health-related conditions. Generally speaking, these interventions can be subdivided into medicinal products and medical devices, although the distinctions between these categories can be blurred and some commercialized products comprise both. In most of the world, the rules for these two broad categories differ somewhat, although many of the basic principles are the same. Over the past century, regulators in the United States and in the European Union have developed complex frameworks for the regulation of medicines and medical devices marketed within their borders. These frameworks have evolved in response to public health crises. Both jurisdictions seek assurance that medicines and medical devices are safe and effective for their intended purposes. Policymakers in both jurisdictions, as elsewhere in the world, must also strike a balance between encouraging innovation and ensuring a steady supply of newer medical treatments while also ensuring that available medical treatments are in fact affordable for payers and patients.

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

This chapter examines the regulation of medicines in the United States. The US scheme for achieving the primary goals of medical product regulation is largely federal, governed by the Food, Drug, and Cosmetic Act and two provisions of the Public Health Service Act and administered by the US Food and Drug Administration (FDA), a federal executive branch agency within the US Department of Health and Human Services. Federal law generally requires research before a medical product enters the market, FDA authorization before market launch affirming that there is sufficient evidence of the product's safety and effectiveness, and continued monitoring and regulation after launch. These requirements and how they are implemented, however, reflect values and goals that, in some circumstances, can be in tension. The chapter then considers how the regulatory scheme for medicines seeks to reconcile these sometimes competing values and goals. It starts by describing what constitutes a medicine subject to FDA regulation and then explains how medicines reach the market, how the FDA and manufacturers assess and manage risks, and the incentives for innovation and rules for competition. The chapter also looks at innovative medical technologies that challenge the traditional US regulatory scheme, using those examples to explore the future of medicines regulation.

Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits—such as expanding access to testing and reducing the risk of exposure for consumers and medical personnel—it also raises significant ethical and regulatory concerns. This article reviews these challenges and shows how they parallel and also diverge from prior concerns raised in the DTC health testing arena. The first part of this paper provides an overview of the landscape of diagnostic and serological tests for COVID-19, anticipating how provision models are likely to evolve in the future. The second part discusses five primary issues for DTC COVID-19 tests: test accuracy; potential misinterpretation of results; misleading claims and other misinformation; privacy concerns; and fair allocation of scarce resources. We conclude with recommendations for regulators and companies that aim to ensure ethically marketed DTC COVID-19 tests.

Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.

This Chapter explains how drugs and vaccines for COVID-19 can reach the market in the United States. As is always true, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional approval mechanisms and drug manufacturers may offer pre-approval access under the expanded access or right to try pathways. In a public health emergency like COVID-19, an additional mechanism is also available: the Emergency Use Authorization (EUA) pathway. This Chapter (1) assesses how FDA has used its EUA authorities for COVID-19 drugs thus far, (2) considers how FDA has balanced the need for robust evidence of safety and effectiveness for COVID-19 pharmaceuticals against the urgent need to speed patients’ access amid the clinical and political realities of the pandemic, and (3) highlights considerations specific to vaccines should FDA be faced with a request to issue an EUA for a COVID-19 vaccine. The Chapter concludes with recommendations for policymakers and regulators at the federal and state levels. The recommendations aim to improve public understanding of the regulatory process for COVID-19 drugs and vaccines, protect scientific decision making from undue political pressure, and ensure that manufacturers develop robust evidence of safety and effectiveness—and ultimately safe and effective COVID-19 countermeasures. This paper was prepared as part of Assessing Legal Responses to COVID-19, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

The field of regenerative medicine is widely viewed as having the potential to improve treatment options for a broad range of conditions. Stem cell research in particular has been celebrated for its considerable clinical promise. Although measured enthusiasm surrounding this area of research is warranted, it must be balanced by patience and set in the context of a long-term perspective that is cognizant of the many steps required to bring safe and efficacious therapies to market. Creating therapeutic applications of stem cell technologies is an intricate process involving complex biology. It will require careful scientific investigation and evaluation under responsible ethical frameworks and regulatory standards in order to safely maximize their potential. Alongside the many promising avenues of responsible research currently underway in countries throughout the world, a global market has emerged where a wide range of putative stem cell-based interventions are sold on a direct-to-consumer basis and marketed over the internet.1,2,3,4 In this paper, we discuss a number of concerns associated with this market that stem from a lack of clarity in several key areas, and propose approaches for how they might be remedied. Although we are not the first to identify many of these concerns, their persistence demonstrates the need for clear and concise actions. The market for unproven stem cell-based interventions engages varied interests and crosses different regulatory, research, and clinical domains. We draw on the considerable body of work in this area to highlight the contributing factors to this problem and to facilitate actions to ameliorate some of the most concerning issues. Engaging the different groups and entities that are involved in this space, and clarifying and coordinating their actions, will be critical to the success of policy efforts aimed at mitigating the risks of this market while promoting responsible progress in stem cell research.5 Numerous issues and concerns with the market for unproven stem cell-based interventions have been identified. Many for-profit clinics selling unproven stem cell-based interventions directly to patients take advantage of the hyperbole surrounding stem cell research6,7,8 to advertise their products and services. In many cases, interventions are sold that have no established biomedical or scientific basis (eg stem cell-based treatments for autism). In other instances, the interventions offered may be rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use (eg adipose derived stem cells for treatment of orthopedic injuries). At times, it appears that uncontrolled and non-standardized products are being administered, without credible evidence that the products contain active stem cells or have demonstrated any regenerative effects. In addition to other concerns (eg potential fraud and financial loss), when these unproven interventions are advertised and administered without an adequate evidence base, they risk causing serious injury to patients and violating professional and legal standards.9,10,11 For example, recent reports of adverse results include lesions of the spinal cord12 and retinal detachments following intraocular injection of adipose-derived stem cells.13 A comprehensive analysis of reported adverse events from patients who received unproven stem cell-based interventions published in 2018 details 35 cases of acute or chronic complications or death, emphasizing the potentially serious consequences of these unproven interventions.14 Early research investigating this global online direct-to-consumer marketplace for purported stem cell interventions revealed a preponderance of clinics in China, India, and Mexico.15,16 More recent research documents a growth of the market in such countries as the United States, Canada, Australia, and Japan.17,18,19,20 For example, one empirical study of the US direct-to-consumer marketplace for unproven stem cell interventions found over 350 businesses marketing putative ‘stem cell treatments’ for a wide range of diseases and injuries, and a recent update describes 716 clinics operating in 45 of the 50 US states.21 The risks associated with different supposed stem cell-based interventions available on the private market vary tremendously and depend on numerous factors including the source and type of cells used; the quality of harvesting and processing procedures and facilities; levels of procedural reproducibility and quality control; the manner and site of cell administration; the training and expertise of the health care team and the degree and quality of post-procedure care and follow-up. Leading scientific bodies such as the International Society for Stem Cell Research (ISSCR) have made important strides in developing voluntary guidelines for stem cell research and clinical translation pathways.22 However, as the global market for stem cell interventions continues to expand and diversify, it is increasingly difficult to draw sharp lines between what may constitute responsible and ethical instances of medical innovation,23,24 and activities that are clearly unethical because of the inappropriate personal financial burden they may create for the patient, the risks they pose, the uncertainties about their risks, or the lack of any potential benefits. This murkiness and the growing difficulties associated with identifying clear ‘red flags’ of problematic commercial activity creates challenges for prospective patients, health care providers, and regulators alike. We suggest that there is a need for policy makers and stakeholders to focus on achieving informational clarity about stem cell interventions in three key and interconnected areas, each of which carries different responsibilities for those involved: (i) with regulation that is clear and comprehensive, as well as consistently and robustly enforced; (ii) with scientific and clinical transparency, and (iii) with patient communication and engagement strategies that prioritize informed decision-making, accurate representations, and realistic expectations. Improvements in each of these domains depends on progress in the others. Effective regulation requires scientific and clinical precision. Similarly, truly informed decision-making by patients demands a clear understanding of scientific and clinical realities, while responsible scientific and clinical progress is facilitated by clear and consistent regulation that oversees the production of a high-quality product, thus improving reliability, patient confidence, and decision-making. We situate our analysis and recommendations largely in the Canadian and US contexts. In both countries, we see opportunity for timely, strategic interventions to restrict proliferation of the most egregious and concerning forms of this market. We also note however that the global nature of this market demands an important role for international cooperation and coordination.

The US Food and Drug Administration has announced that it is considering lowering nicotine levels in cigarettes to “minimally addictive or nonaddictive levels.” This could be a transformative public health measure, but the tobacco industry is likely to challenge such an action in court. This article reviews some of the key legal arguments that industry is likely to advance and considers possible responses. As we demonstrate, there are strong arguments that the US Food and Drug Administration has the authority to implement a policy to reduce nicotine in cigarettes to nonaddictive levels.

In their article “The Rise of Citizen Science in Health and Biomedical Research,” Wiggins and Wilbanks (2019) present a new typology for understanding the complex landscape of health and biomedical...

No abstract available.

Emphasize community engagement, not perfect compliance

What, exactly, is "gene therapy"? Crystallizing a modern definition of "gene therapy" has now become critically important on several fronts. Following the recent of passage the 21st Century Cures Act, FDA now relies on the term to give regulatory incentives to sponsors of certain ‘regenerative medicines’, including ‘gene therapies’. NIH Director Francis S. Collins and FDA Commissioner Scott Gottlieb recently announced that Recombinant DNA Advisory Committee ("RAC") approval would no longer be required for "gene therapy" because "there is no longer sufficient evidence to claim that the risks of gene therapy are entirely unique and unpredictable." And in July 2018 FDA issued six draft guidance documents on "gene therapy" but none with a substantially new definition. We review the contours ofthe term here, and propose that "gene therapy"— in the lay, scientific, and legal sense — should be defined as an intentional and expected permanent alteration of a specific DNA sequence of the cellular genome — that is, the sum of DNA that exists within a cell — for a clinical purpose. We also propose that gene therapy, as we define it, can be further categorized into at least three types: direct,compensatory, and augmenting. Defining gene therapy in this fashion would provide clarity to scientists and regulators alike.

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new "comprehensive plan for tobacco and nicotine regulation." This plan is focused on making cigarettes less addictive while facilitating the development of alternative, and less-harmful, nicotine-containing products. This approach holds promise, and the public health stakes could not be higher-smoking is the leading cause of preventable death in the United States, resulting in roughly 480,000 deaths per year. But a new consumer product is emerging that could upset the FDA's plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act's (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA's plan for tobacco and nicotine regulation. This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA's past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine products satisfy the FDCA's definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine products as drugs.

“Biohacking” has emerged as a cultural and scientific phenomenon. Although there is no consensus on the precise definition of “biohacking,” the term generally describes biological investigations and interventions that are conducted outside of typical scientific settings by individuals who may not have traditional scientific training. Easier access to biological information and resources has enabled biohacking to flourish. Its participants often describe their activities as motivated by a belief in a right to “do science,” a high value placed on bodily autonomy, and a view that traditional scientific institutions and regulations have systematically failed to benefit society. At the same time, the November 2018 announcement that a scientist in China used CRISPR to genetically modify viable human embryos — allegedly resulting in the birth of the first “CRISPR babies” — has reinvigorated concerns about the distribution of genetic technologies. For genetic biohacking, these concerns may be heightened by a belief that mechanisms to regulate the activity are absent or inadequate to address its risks. But, as this chapter details, genetic biohacking is likely subject to numerous oversight mechanisms, both public and private. Before calling for additional regulations, these extant mechanisms should be evaluated.

The Food and Drug Administration's expanded access program allows patients with serious or immediately life-threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act of 2016 sought to increase the transparency of manufacturers' approaches to expanded access by requiring public listing of five key pieces of information about their expanded access programs: 1) relevant contact information, 2) procedures for making requests, 3) general criteria used to evaluate requests, 4) length of time anticipated to acknowledge receipt of requests, and 5) a reference to pertinent information on ClinicalTrials.gov. Manufacturers were given 60 days from the Act's enactment, or until February 11, 2017, to post this information. We reviewed a sample of pharmaceutical manufacturers' expanded access policies to determine what information is readily available to patients online, including assessing whether the information described in the Act is available.

In this article, we consider the problem of financing highly effective and cost-effective prescription drugs within a value-based pricing system. Precisely because these drugs are highly effective, their value-based prices may be quite expensive; and moreover, the value-based price of a cure ought to be set high enough to create incentives for innovation, otherwise these beneficial therapies may be underdeveloped. However, in our fragmented health insurance system, where patients move frequently between payers, these payers generally lack the incentives to pay value-based prices for cures because they cannot ensure that they will reap the long-term economic benefits. Therefore, we argue that there is a need for mechanisms to spread the burden of financing of cures across payers to maximize patient access and the public good. We suggest that risk adjustment, reinsurance, and risk corridors are familiar policy options that merit consideration to address the problem and create incentives for value-based pricing.

Academic health centers (AHCs), which are at the forefront of stem cell research, need to establish institutional stem cell research oversight committees (SCROs) to comply with 2005 National Academy of Sciences (NAS) recommendations and to establish public trust in this sensitive research. Institutional review boards (IRBs) typically lack the expertise and time to adequately review the specific ethical issues raised by stem cell research. To assure careful, timely, and coordinated review of the science and ethics of stem cell protocols, AHCs need to address many practical procedural issues, such as SCRO membership, quorum, conflicts of interest, and procedures for protocol review. The SCRO committee at the University of California San Francisco (UCSF), established in 2003, has developed detailed policies and procedures on these issues. The UCSF SCRO has broad scientific expertise and uses ad hoc reviewers to strengthen the review process. Studies receiving full SCRO review have three lead reviewers: a scientist, a reviewer with ethics expertise, and a public representative. Studies introducing human stem cells into nonhuman blastocysts receive full review, even if the stem cells are anonymized. Some protocols are eligible for expedited review. The SCRO neither replaces nor duplicates review by the IRB and institutional animal care and use committees. Other AHCs can draw on the UCSF experience when developing their own policies and procedures for stem cell research oversight.

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for phase I clinical trials of hESC transplantation also raises ethical concerns. In previous phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus, researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress toward stem cell therapies.

State right-to-try laws revive a decades-long debate about balancing early access to unapproved medications for terminally ill patients with requirements for demonstrated safety and effectiveness. Although the legal approach is novel, there are many reasons to believe that the laws are likely to be futile. The laws also raise questions about the roles of the state and federal governments in overseeing drugs and medical devices.

By the end of the first year, infants are able to recognize both goal-directed and perceptually guided behavior in the actions of non-human agents, even faceless ones. How infants derive the relevant orientation of an unfamiliar agent in the absence of familiar markers such as eyes, ears, or face is unknown. The current studies tested the hypothesis that infants’ calculate an agent's “front” from the geometry of its behavior in the spatial environment. In the first study, 14–15-month-old infants observed a symmetrical, faceless agent either interact contingently with a confederate or act randomly. It then turn toward one of two target objects. Infants were more likely to look in the direction the agent turned than the opposite direction, but only in the contingent condition. In the second study, the location of the confederate and target objects was varied, which in turn influenced which end of the agent infants interpreted as the front. Finally, implications for infants’ early gaze-following behaviors with humans are tested and implications for theory of mind development more broadly are discussed.

In Back to First Principles: A New Model for the Regulation of Drug Promotion, Alan Bennett and co-authors rightly argue that it is time for the U.S. Food and Drug Administration (FDA) to reconsider its scheme for regulating prescription drug promotion.1 Bennett and his co-authors assert that the FDA’s framework for overseeing prescriptiondrug promotion is outdated because itwas developedover 50 years ago when communication techniques and technologies, and First Amendment jurisprudence regarding protections for commercial speech, were appreciably different.2 Indeed, as Bennett and colleagues note, the FDA itself appears to agree that change, or at least clarification, may be warranted. For example, in recent years, the FDA has held or announced public meetings to solicit stakeholder input, announced a number of studies of drug promotion, and has issued several draft guidance documents intended to clarify certain aspects of its regulation of prescription drug promotion.3 Bennett and colleagues propose a ‘New Model’ to modernize the FDA’s regulatory scheme. The New Model would create three categories of drug manufacturer

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.