Debate: Building a U.S. Regulatory Empire in the Chip War with China.

Regulating the circulation of technology is a powerful weapon to exercise global power. In August 2022, U.S. president Joe Biden moved to strangle China's high-end semiconductor industry by imposing a swath of export controls aimed at restricting the country's access to global semiconductor supply chains. While this chip war is usually framed as a bilateral conflict between Washington and Beijing, the success of the U.S. strategy depends on the active cooperation of allied firms and governments. This article fills a critical gap in the standard narrative. It describes how the U.S. government has constructed an empire by regulation, leveraging its global political and economic power to impose extraterritorial export controls on allied trade. By seeking to regulate the flow of technology, knowledge, people, and foreign investment into China, the U.S. risks alienating traditional allies and has triggered China to seek self-sufficiency in the production of advanced semiconductors for civilian and military applications.

FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

Covid-19 in Historical Context: Creating a Practical Past.

Decades ago, in his foundational essay on the early days of the AIDS crisis, medical historian Charles Rosenberg wrote, "epidemics start at a moment in time, proceed on a stage limited in space and duration, following a plot line of increasing revelatory tension, move to a crisis of individual and collective character, then drift toward closure." In the course of epidemics, societies grappled with sudden and unexpected mortality and also returned to fundamental questions about core social values. "Epidemics," Rosenberg wrote, "have always provided occasion for retrospective moral judgment" (Rosenberg 1989, pp. 2, 9). Following Rosenberg's observations, this essay places COVID-19 in the context of epidemic history to examine common issues faced during health crises-moral, political, social, and individual. Each disease crisis unfolds in its own time and place. Yet, despite specific contexts, we can see patterns and recurring concerns in the history of pandemics: (1) pandemics and disease crises in the past, along with public health responses to them, have had implications for civil liberties and government authority; (2) disease crises have acted as a sort of stress test on society, revealing, amplifying or widening existing social fissures and health disparities; (3) pandemics have forced people to cope with uncertain knowledge about the origin and nature of disease, the best sources of therapies, and what the future will hold after the crisis. While historians are not prognosticators, understanding past experience offers new perspectives for the present. The essay concludes by identifying aspects of history relevant to the road ahead.

Mandatory Bicycle Helmet Laws in the United States: Origins, Context, and Controversies.

This article examines the origins and context of mandatory bicycle helmet laws in the United States. Localities began to enact such laws in the early 1990s, having experimented with helmet laws for motorcycles previously. As cycling became increasingly popular in the 1970s and 1980s because of a variety of historical trends, from improved cycle technology to growing environmental consciousness, cycling-related injuries also increased. Bicycle safety advocates and researchers alike were particularly troubled by head injuries. National injury surveillance systems and a growing body of medical literature on bicycle-related injuries motivated a number of physicians, cyclists, children, and other community members to advocate helmet laws, which they argued would save lives. Controversy over these laws, particularly over whether they should apply universally or only to children, raised public health ethics concerns that persist in contemporary debates over bicycle helmet policies. (Am J Public Health. 2020;110:1198-1204. doi: 10.2105/AJPH.2020.305718).

Tobacco control in Nepal during a time of government turmoil (1960-2006).

BACKGROUND: Nepal was a monarchy, then a dictatorship, then a democracy. This paper reviews how tobacco control progressed in Nepal in the context of these changes in government from 1950 through 2006. METHODS: We triangulated tobacco industry documents, newspaper articles and key informant interviews. RESULTS: Until 1983, the tobacco industry was mostly state owned. Transnational tobacco companies entered the Nepalese market through ventures with Surya Tobacco Company Private Limited (with Imperial Tobacco Company and British American Tobacco) in 1983 and Seti Cigarette Factory Limited (with Philip Morris International [PMI]) in 1985. Seminars and conferences on tobacco, celebrations of World No Tobacco Day (WNTD) and efforts by WHO helped promote tobacco control in Nepal beginning in the 1970s. Tobacco advocates in Nepal pushed the government to issue executive orders banning smoking in public places in 1992 and tobacco advertising in electronic media in 1998, and to introduce a tobacco health tax in 1993. The tobacco industry lobbied against these measures and succeeded in keeping the tobacco tax low by challenging it in court. Tobacco advocates sued the government in 2003 and 2005, resulting in a June 2006 Supreme Court decision upholding the smoking and advertising bans and requiring the government to enact a comprehensive tobacco control law. CONCLUSIONS: Political instability, conflict, weak governance and the dictatorship significantly affect tobacco control activities in low-income and middle-income countries. Nepal shows that tobacco control advocates can take advantage of global events, such as WNTD, and use domestic litigation to maintain support from civil societies and to advocate for stronger tobacco control policies.

Evolution of Federalism in Environmental Health: Federal, State, and Local Government Control.

Environmental health sits at the intersection of public health and environmental protection. Governments often confront environmental health concerns through environmental laws. Authority to take actions like passing these laws is determined by federalism, which divides the authority to make laws and policies on various issues between those levels of government. However, tensions often arise when these levels of government attempt to share regulatory authority over environmental issues. Issues of federalism are especially prevalent in environmental health issues, where incidents not only cross state and local borders and affect different levels of government but may also involve both environmental and health agencies. This article describes the history of environmental federalism in the United States through the lens of public health, including how the regulatory structure transitioned from primarily state control to a more centralized federal system of governance. It also describes modern federalism in environmental health, the levels of government involved in environmental health decisions, and the legal authorities that allow these governments to regulate environmental health in the United States. Finally, this article describes the implications of federalism in environmental health.

Regulating Homeopathic Products - A Century of Dilute Interest.

In 2015, U.S. government agencies began considering greater regulation of both homeopathic drugs and the advertising of such products. These actions came after more than a century of missed opportunities to regulate homeopathic medicines.

Pediatric drug regulation: International perspectives.

There was a time when the predominant approach to exposing children to new drugs was to protect children from research. This has evolved over the past several decades into protecting children through research. To encourage pediatric studies and approval of pediatric medicines, governments have provided financial incentives as well as obligations/requirements for pharmaceutical companies to carry out pediatric studies in certain circumstances. The unique considerations for children have been acknowledged by the various governments and drug regulatory agencies through international dialogue and cooperation among patient and patient care representatives, regulatory agencies, and academic, clinical and manufacturing stakeholders. We describe pediatric drug regulation in five of the largest international drug regulatory agencies and additionally discuss efforts at international cooperation and discussion in pediatric drug regulation.

Rothschild reversed: explaining the exceptionalism of biomedical research, 1971-1981.

The 'Rothschild reforms' of the early 1970s established a new framework for the management of government-funded science. The subsequent dismantling of the Rothschild system for biomedical research and the return of funds to the Medical Research Council (MRC) in 1981 were a notable departure from this framework and ran contrary to the direction of national science policy. The exceptionalism of these measures was justified at the time with reference to the 'particular circumstances' of biomedical research. Conventional explanations for the reversal in biomedical research include the alleged greater competence and higher authority of the MRC, together with its claimed practical difficulties. Although they contain some elements of truth, such explanations are not wholly convincing. Alternative explanations hinge on the behaviour of senior medical administrators, who closed ranks to ensure that de facto control was yielded to the MRC. This created an accountability deficit, which the two organizations jointly resolved by dismantling the system for commissioning biomedical research. The nature and working of medical elites were central to this outcome.

The Role of Health in Climate Litigation.

OBJECTIVES: To examine how the courts, which play a critical role in shaping public policy, consider public health in climate change and coal-fired power plant lawsuits. METHODS: We coded US local, state, and federal court decisions relating to climate change and coal-fired power plants from 1990 to 2016 (n = 873) and qualitatively investigated 139 cases in which litigants raised issues concerning the health impacts of climate change. We also conducted 78 interviews with key litigants, advocates, industry representatives, advising scientists, and legal experts. RESULTS: Health has been a critical consideration in key climate lawsuits, but in a minority of cases. Litigants have presented health arguments most frequently and effectively in terms of airborne exposures. Health impacts have typically been used to gain standing and argue that the evidence for government actions is insufficient. CONCLUSIONS: The courts represent a pivotal branch of government in shaping climate policy. Increasing inclusion of health concerns in emergent areas of litigation could help drive more effective climate policymaking.

"A kind of agonie in my thoughts": writing puritan and non-conformist women's pain in 17th-century England.

The relationship between pain as a physical and emotional experience and the concept of suffering as an essential aspect of sanctification for faithful believers was a paradoxical and pressing theological and phenomenological issue for puritan and non-conformist communities in 17th-century England. Pain allows the paradox of non-conformists' valorisation and suppression of corporeality to be explored due to its simultaneous impact on the mind and body and its tendency to leak across boundaries separating an individual believer from other members of their family or faith community. The material world and the human body were celebrated as theatres for the display of God's glory through the doctrines of creation and providence despite the fall. Pain as a concept and experience captures this tension as it was represented and communicated in a range of literary genres written by and about puritan and non-conformist women including manuscript letters, spiritual journals, biographies and commonplace books. For such women, targeted by state authorities for transgressing gender norms and the religion established by law, making sense of the pain they experienced was both a personal devotional duty and a political act. Three case studies comprise a microhistory of 17th-century English puritan and non-conformist women's lived experience, interpretation and representation of pain, inscribed in a series of manuscripts designed to nurture the spiritual and political activism of their communities. This microhistory contributes to a better understanding of pain in early modern England through its excavation of the connections that such writers drew between the imperative to be visibly godly, their marginalised subject position as a proscribed religious minority and their interpretation of the pain they experienced as a result.

Swann Song: Antibiotic Regulation in British Livestock Production (1953-2006).

Antibiotics have played a significant yet ambivalent role in Western livestock husbandry. Mass introduced to agriculture to boost animal production and reduce feed consumption in the early 1950s, agricultural antibiotics were soon accused of selecting for bacterial resistance, causing residues and enabling bad animal welfare. The dilemma posed by agricultural antibiotic regulation persists to this day. This essay traces the history of British antibiotic regulation from 1953 to the influential 1969 Swann report. It highlights the role that individual experts using bacteriophage typing played in warning about the mass selection for bacterial resistance on farms and the response of a corporatist system, whose traditional laissez-faire arrangements struggled to cope with the risk posed by bacterial resistance. In addition to contextualizing the Swann report's origins, the essay also discusses the report's fate and implications for current antibiotic regulation.

Non-stick science: Sixty years of research and (in)action on fluorinated compounds.

Understandings of environmental governance both assume and challenge the relationship between expert knowledge and corresponding action. We explore this interplay by examining the context of knowledge production pertaining to a contested class of chemicals. Per-and polyfluorinated alkyl substances (PFASs) are widely used industrial compounds containing chemical chains of carbon and fluorine that are persistent, bioaccumulative and toxic. Although industry and regulatory scientists have studied the exposure and toxicity concerns of these compounds for decades, and several contaminated communities have documented health concerns as a result of their high levels of exposure, PFAS use remains ubiquitous in a large range of consumer and industrial products. Despite this significant history of industry knowledge production documenting exposure and toxicity concerns, the regulatory approach to PFASs has been limited. This is largely due to a regulatory framework that privileges industry incentives for rapid market entry and trade secret protection over substantive public health protection, creating areas of unseen science, research that is conducted but never shared outside of institutional boundaries. In particular, the risks of PFASs have been both structurally hidden and unexamined by existing regulatory and industry practice. This reveals the uneven pathways that construct issues of social and scientific concern.

A Crispr Future for Gene-Editing Regulation: a Proposal for an Updated Biotechnology Regulatory System in an Era of Human Genomic Editing.

Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.