In “Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency,” Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Obesity, excess adipose tissue accumulation that may impair health, is a major global healthcare challenge that increases the risk of several life-limiting diseases, reduces quality of life and leads to premature mortality. Weight loss improves or leads to the resolution of obesity-related diseases. Lifestyle interventions are the cornerstone for all weight management programmes and lead to health benefits. However, for the majority of people with severe obesity, lifestyle interventions and currently available anti-obesity medications lead to insufficient weight loss to improve their health. For these patients the only effective treatment option is bariatric surgery, which whilst highly effective, is difficult to access and not suitable for everyone, leaving a ‘treatment gap’ between lifestyle interventions and bariatric surgery. Unfortunately, the history of development of drugs to treat obesity has been marred by poor efficacy and safety issues. This is now set to change as a result of scientific advancements, which have increased the understanding of the role that gut hormones play in regulating energy and glucose homoeostasis. This has led to the development of effective, safe drugs based on gut hormones that target the body's own appetite regulating systems that herald a new era of treatments for people living with obesity.

Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.

This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.

Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.

Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.

This article looks at the implementation of food standards of identity by the U.S Food and Drug Administration from the 1930s to the 1960s, a period in the FDA’s history wedged between the “era of adulteration” of the early twentieth century and the agency’s turn to “informational regulation” starting in the 1970s. The article describes the origin of food standards in the early twentieth century and outlines the political economy of government-mandated food standards in the 1930s. While consumer advocates believed government standards would be important to consumer empowerment because they would simplify choices at the grocery store, many in the food industry believed government standards would clash with private brands. The FDA faced challenges in defining what were “customary” standards for foods in an increasingly industrial food economy, and new diet-food marketing campaigns in the 1950s and 1960s ultimately led to the food standards system's undoing. The article concludes by looking at how FDA food standards came to be framed cynically, even though voluntary food standardization continued and the system of informative labeling that replaced FDA standards led to precisely the problem government standards were intended to solve.

The gluten-free diet is based on the consumption of foods without gluten, which aims to manage celiac disease. The concern of celiac patients is that these foods should be safe. However, gluten contamination can affect these foods. The objectives of this review and meta-analysis were first, to identify articles that detected gluten contamination in gluten-free foods using validated methods. Second, to quantify the overall prevalence of gluten contamination of naturally gluten-free foods, labelled gluten-free products, and meals prepared in food services. Third, to highlight the influence of the country’s income and the period of study on this prevalence. The studies were identified in Scopus, Science Direct, Web of Science, PubMed, and Google Scholar. Forty articles were included according to PRISMA guidelines. The statistical meta-analysis was performed using MedCalc 19 software. The results show that in the gluten-free foods analysed, the overall prevalence of gluten contamination was estimated at 15.12% (95% CI: 9.56%–21.70%), with more than 20 mg/kg of gluten. Naturally gluten-free foods were significantly more contaminated than labelled gluten-free products and than meals in food services (28.32%; 9.52%; 4.66% respectively; p < 0.001). Moreover, it was noticed that oats were the most contaminated food. In addition, the prevalence of gluten contamination has significantly decreased over time. The majority of the studies were carried out in upper-middle-income and high-income countries, while only one study was conducted in lower-middle income countries. Therefore, it is necessary to implement preventive actions to reduce gluten contamination, ensuring safe gluten-free foods for celiac patients, including low-income countries.

Over-the-counter (OTC) drugs are ubiquitous in the US. Policymakers have long debated how to modernize the system for making determinations of safety and effectiveness and addressing safety issues with OTC drugs.

We read with interest the recent editorial, “The Hennepin Ketamine Study,” by Dr. Samuel Stratton commenting on the research ethics, methodology, and the current public controversy surrounding this study.1 As researchers and investigators of this study, we strongly agree that prospective clinical research in the prehospital environment is necessary to advance the science of Emergency Medical Services (EMS) and emergency medicine. We also agree that accomplishing this is challenging as the prehospital environment often encounters patient populations who cannot provide meaningful informed consent due to their emergent conditions. To ensure that fellow emergency medicine researchers understand the facts of our work so they may plan future studies, and to address some of the questions and concerns in Dr. Stratton’s editorial, the lay press, and in social media,2 we would like to call attention to some inaccuracies in Dr. Stratton’s editorial, and to the lay media stories on which it appears to be based.

Ho JD, Cole JB, Klein LR, Olives TD, Driver BE, Moore JC, Nystrom PC, Arens AM, Simpson NS, Hick JL, Chavez RA, Lynch WL, Miner JR. The Hennepin Ketamine Study investigators’ reply. Prehosp Disaster Med. 2019;34(2):111–113

The probability of a Black African finding a matched unrelated donor for a hematopoietic stem cell transplant is minimal due to the high degree of genetic diversity amongst individuals of African origin. This problem could be resolved in part by the establishment of a public cord blood (CB) stem cell bank. The high prevalence of human immunodeficiency virus (HIV) amongst women attending antenatal clinics in sub-Saharan Africa together with the risk of mother-to-child transmission increases the risk of transplant transmissible infection. In addition to screening the mother in a period inclusive of 7 days prior to the following delivery, we propose that all CB units considered for storage undergo rigorous and reliable screening for HIV. The Ultrio-plus® assay is a highly specific and sensitive test for detecting HIV, hepatitis-B and hepatitis-C viruses in peripheral blood. We validated the Ultrio-plus® assay for analytical sensitivity in detecting HIV in CB at the level of detection of the assay. Until more comprehensive and sensitive methods are developed, the sensitivity and reliability of the Ultrio-plus® assay suggest that it could be used for the routine screening of CB units in conjunction with currently recommended maternal screening to reduce the risk of transplant transmissible infection.

Nutrient profiling (NP) models rate the nutritional quality of individual foods, based on their nutrient composition. Their goal is to identify nutrient-rich foods, generally defined as those that contain more nutrients than calories and are low in fat, sugar and salt. NP models have provided the scientific basis for evaluating nutrition and health claims and regulating marketing and advertising to children. The food industry has used NP methods to reformulate product portfolios. To help define what we mean by healthy foods, NP models need to be based on published nutrition standards, mandated serving sizes and open-source nutrient composition databases. Specifically, the development and testing of NP models for public health should follow the seven decision steps outlined by the European Food Safety Authority. Consistent with this scheme, the nutrient-rich food (NRF) family of indices was based on a variable number of qualifying nutrients (from six to fifteen) and on three disqualifying nutrients (saturated fat, added sugar, sodium). The selection of nutrients and daily reference amounts followed nutrient standards for the USA. The base of calculation was 418·4 kJ (100 kcal), in preference to 100 g, or serving sizes. The NRF algorithms, based on unweighted sums of percent daily values, subtracted negative (LIM) from positive (NRn) subscores (NRn – LIM). NRF model performance was tested with respect to energy density and independent measures of a healthy diet. Whereas past uses of NP modelling have been regulatory or educational, voluntary product reformulation by the food industry may have most impact on public health.