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.

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.

[Regulation of drug prices in nineteenth-century Bazilian pharmacy]. / O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista.

On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

O Regimento dos preços dos medicamentos... na farmácia brasileira oitocentista / Regulation of drug prices in nineteenth-century Bazilian pharmacy

Resumo Em 5 de novembro de 1808, dom João de Bragança promulgou um alvará sobre o exercício dos boticários e o preço das drogas e ordenou a criação de um regulamento para taxar o custo dos medicamentos comercializados no Brasil. Publicado pela primeira vez em 1809, o Regimento dos preços dos medicamentos... ganhou novas edições nos anos subsequentes e tornou-se um indispensável instrumento de trabalho para os envolvidos com a feitura e o comércio dos remédios. Este texto situa historicamente e destaca esse documento brevemente explorado pelos pesquisadores da história da farmácia brasileira, visto ter sido uma das primeiras iniciativas do governo luso-brasileiro condizentes com a atividade farmacêutica no Brasil no século XIX.

Abstract On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

Transvestism and transsexuality in Argentine medical journals, 1971-1982. / Travestismo y transexualidad en las revistas argentinas de medicina, 1971-1982.

This article deals with the discourses produced by the Argentine medical field relating to body transformation initiatives on the part of transvestites and transsexuals in Argentina from 1971-1982. Based on the compilation and analysis of a set of articles published in academic medical journals, it examines the meanings that health professionals assigned to these initiatives prior to the legal rulings and national legislation that recognized gender identity as a human right. This analysis helps identify the particular features of those body transformation initiatives during the period studied, as well as the ways in which the medical field in Argentina attached moral, technical and professional meanings to them.

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).

Travestismo y transexualidad en las revistas argentinas de medicina, 1971-1982 / Transvestism and transsexuality in Argentine medical journals, 1971-1982

Resumen El presente artículo aborda los discursos producidos por el campo médico argentino en torno a las iniciativas de corporización de travestis y transexuales en Argentina entre 1971 y 1982. A través del relevamiento y análisis de una selección de artículos publicados en revistas académicas de medicina, se analizan los sentidos que profesionales de la salud asignaron a las mismas antes de la producción de fallos judiciales y normativas nacionales que reconocen la identidad de género como un derecho humano. El análisis realizado permite identificar las particularidades que asumían dichas iniciativas de corporización en el período de estudio, así como las formas en las que el campo médico argentino les imprimió sentidos morales, técnicos y profesionales.

Abstract This article deals with the discourses produced by the Argentine medical field relating to body transformation initiatives on the part of transvestites and transsexuals in Argentina from 1971-1982. Based on the compilation and analysis of a set of articles published in academic medical journals, it examines the meanings that health professionals assigned to these initiatives prior to the legal rulings and national legislation that recognized gender identity as a human right. This analysis helps identify the particular features of those body transformation initiatives during the period studied, as well as the ways in which the medical field in Argentina attached moral, technical and professional meanings to them.

'There Are No Other Options?': Rwandan Gender Norms and Family Planning in Historical Perspective.

This article surveys the evolution of Rwandan family planning practices from the nation's mythico-historical origins to the present. Rwanda is typically regarded as a patriarchal society in which Rwandan women have, throughout history, endured limited rights and opportunities. However, oral traditions narrated by twentieth-century Rwandan historians, storytellers and related experts, and interpreted by the scholars and missionaries who lived in Rwanda during the nation's colonial period, suggest that gender norms in Rwanda were more complicated. Shifting practices related to family planning - particularly access to contraception, abortion, vasectomies and related strategies - are but one arena in which this becomes evident, suggesting that women's roles within their families and communities could be more diverse than the historiography's narrow focus on women as wives and mothers currently allows. Drawing upon a range of colonial-era oral traditions and interviews conducted with Rwandans since 2007, I argue that Rwandan women - while under significant social pressure to become wives and mothers throughout the nation's past - did find ways to exert agency within and beyond these roles. I further maintain that understanding historical approaches to family planning in Rwanda is essential for informing present-day policy debates in Rwanda aimed at promoting gender equality, and in particular for ensuring women's rights and access to adequate healthcare are being upheld.

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.

The regulation of competition and procurement in the National Health Service 2015-2018: enduring hierarchical control and the limits of juridification.

Since 1990, market mechanisms have occurred in the predominantly hierarchical National Health Service (NHS). The Health and Social Care Act 2012 led to concerns that market principles had been irrevocably embedded in the NHS and that the regulators would acquire unwarranted power compared with politicians (known as 'juridification'). To assess this concern, we analysed regulatory activity in the period from 2015 to 2018. We explored how economic regulation of the NHS had changed in light of the policy turn back to hierarchy in 2014 and the changes in the legislative framework under Public Contracts Regulations 2015. We found the continuing dominance of hierarchical modes of control was reflected in the relative dominance and behaviour of the sector economic regulator. But there had also been a limited degree of juridification involving the courts. Generally, the regulatory decisions were consistent with the 2014 policy shift away from market principles and with the enduring role of hierarchy in the NHS, but the existing legislative regime did allow the incursion of pro market regulatory decision making, and instances of such decisions were identified.

The sexual life of our time: Medical censorship in early-20th-century England.

This article challenges the widely held belief that early-20th-century England was one of the most sexually repressed countries in the Western world. Late Victorian physicians discussing sexual diseases and dysfunctions were granted immunity from prosecution if their publications were sold through a recognized medical publisher only to Members of the Medical, Legal and Clerical Professions. It was assumed that those same constraints applied to publications concerning the psychology of the sexual life (sexology). In 1908, Rebman Limited, a well-known medical publisher, advertised Eden Paul's (1908) translation of Iwan Bloch's The Sexual Life of Our Time (hereafter, "Sexual Life") without any restrictions. Although a magistrate ruled the book obscene, the U.K. Home Office allowed republication on condition that its sale was strictly limited. The Rebman case reveals how the U.K. Home Office tried to police the new science of sexology by limiting its circulation, not censoring its content. Despite these restrictions, Sexual Life circulated among lay readers, thereby inviting further research into how even "censored" material shaped debates on sexual, social, and political reform. (PsycINFO Database Record (c) 2020 APA, all rights reserved).