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Opportunities to address the failure of online food retailers to ensure access to required food labelling information in the USA
The rapid growth in web-based grocery food purchasing has outpaced federal regulatory attention to the online provision of nutrition and allergen information historically required on food product labels. We sought to characterise the extent and variability that online retailers disclose required and regulated information and identify the legal authorities for the federal government to require online food retailers to disclose such information.
We performed a limited scan of ten products across nine national online retailers and conducted legal research using LexisNexis to analyse federal regulatory agencies' authorities.
USA.
N/A.
The scan of products revealed that required information (Nutrition Facts Panels, ingredient lists, common food allergens and per cent juice for fruit drinks) was present, conspicuous and legible for an average of only 36·5 % of the products surveyed, ranging from 11·4 % for potential allergens to 54·2 % for ingredients lists. More commonly, voluntary nutrition-related claims were prominently and conspicuously displayed (63·5 % across retailers and products). Our legal examination found that the Food and Drug Administration, Federal Trade Commission and United States Department of Agriculture have existing regulatory authority over labelling, online sales and advertising, and Supplemental Nutrition Assistance Programme retailers that can be utilised to address deficiencies in the provision of required information in the online food retail environment.
Information regularly provided to consumers in conventional settings is not being uniformly provided online. Congress or the federal agencies can require online food retailers disclose required nutrition and allergen information to support health, nutrition, equity and informed consumer decision-making.
Journal Article
What drives trust in regulatory agencies? Probing the relevance of governmental level and performance through a cross-national elite experiment on EU regulation
Trust between constituent actors within the European Union (EU)’s multilevel regulatory regimes is decisive for regulatory success. Trust drives information flows, increases compliance, and improves cooperation within these regimes. Despite its importance, systematic knowledge regarding the drivers of trust within regulatory regimes is limited. This paper inquires whether trust in regulatory agencies is influenced by their affiliation with the national or EU governmental level, as well as by their performance. While existing literature predominantly focuses on why citizens place their trust in governments or regulatory agencies, this paper presents original insights regarding the formation of trust among elites within the regulatory regime, including politicians, ministerial officials, agency officials, interest groups, and regulated entities. We employ data obtained from a large-scale vignette experiment conducted in six countries involving 752 decision-makers from relevant organizations. The experimental results suggest that both public and private elite actors’ trust assessment of regulatory agencies does not hinge on cues associated with the governmental level, but rather depends on agency performance. Accordingly, belonging to the national or EU governmental level does not create a difference in trust assessment of regulatory agencies in itself. It, however, shows that particularly elite actors are rather sensitive in terms of the performance of a regulatory agency.
Journal Article
US FDA–accelerated approvals and subsequent withdrawals: influence on Japanese clinical oncology practice guidelines
Summary
The US (US) Food and Drug Administration (FDA)-accelerated approval pathway facilitates early access to oncology drugs based on surrogate endpoints, with required confirmatory post-marketing trials. However, regulatory decisions vary globally, with some drugs withdrawn in the US remaining approved in Japan. We conducted a cross-sectional analysis of Japanese professional society guidelines, evaluating recommendations for seven accelerated approval cancer drugs withdrawn from the US market but retained in Japan. We assessed for level of evidence and level of treatment preference ratings with consensus across guidelines issued by the corresponding Japanese professional societies. Four of the seven drugs (57%) were recommended as highly or moderately preferred treatment options in Japanese guidelines: gemtuzumab ozogamicin for acute myeloid leukemia, gefitinib for EGFR-positive non-small cell lung cancer, bevacizumab for HER2-negative metastatic breast cancer, and atezolizumab with nab-paclitaxel for PD-L1-positive triple-negative breast cancer. Detailed analysis of regulatory history and background of guideline recommendation revealed discrepancies in the assessment of clinical benefits: gemtuzumab ozogamicin failed to demonstrate benefits amid safety concerns, while gefitinib, bevacizumab, and atezolizumab were more controversial, although they did not demonstrate improved overall survival in post-marketing trials. Despite regulatory withdrawal in the US due to unproven clinical benefits, drugs retained in Japan received positive guideline recommendations. This finding highlights regional variations in regulatory decisions and different approaches to benefit-risk assessments, suggesting a need for improved transparency in Japan’s regulatory decisions and guideline recommendations, with clearer justifications for endorsing drugs that are considered to have unproven clinical benefits in the US.
Journal Article
Transgovernmental Networks as Regulatory Intermediaries: Horizontal Collaboration and the Realities of Soft Power
This article explores and elucidates the activities of transnational networks as regulatory intermediaries. Specifically, I examine their role in the regulation of banks, as far as they facilitate exchanges between global regulators (GRs)—such as the Basel Committee on Banking Supervision or the Financial Stability Board—and local regulators (LRs), such as national regulatory agencies or legislatures. I find that transgovernmental network intermediaries produce benefits both for GRs, which employ them to disseminate their rules; and for LRs, which use them to obtain influence, advice, and information. Networks promote collaborative intermediation horizontally, without compromising sovereignty, and require only soft organizational structures with low operational costs. Network intermediation is a key ingredient in facilitating local regulatory activities and in providing tools and cognitive resources to LRs. Network intermediaries blur the global-local boundary, however, as some of their members operate as LRs and simultaneously participate directly in GRs.
Journal Article
Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: a case study of public documents
To assess whether drug regulatory agencies decided on applications for extended-release methylphenidate for use in adult ADHD based on select samples of trials.
Case series of publicly available regulatory documents. We matched an index of extended-release methylphenidate trials for adult ADHD with trials appearing in regulatory documents of extended-release methylphenidate applications. Trials and regulatory documents were identified as part of this systematic review (https://doi.org/10.1002/14651858.CD012857). We sought to identify missing trials in the regulatory documents and to clarify regulatory submission requirements.
We indexed 18 trials and matched those with 13 drug applications (11 approved, 2 rejected) published by 7 agencies. There were trials missing in 7 (54%) of 13 applications, median 4 trials (range 1-6). The median proportion of missing trial participants was 45% (range 23% - 72%). Regulators seemingly require that all trials must be included in new drug applications, but wording is ambiguous.
In this sample of extended-release methylphenidate drug applications for adult ADHD, 7 of 13 regulatory decisions were missing entire trials according to public documents, even though regulatory requirements seem to stipulate that all available trials should be included in drug applications.
Journal Article
Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) countries with mature regulatory systems of Australia, Canada, Singapore and Switzerland. It is hoped that this benchmark study provides an opportunity for BRICS-TM agencies to identify the key areas for improvement in their regulatory processes. Materials and Methods: A semi-quantitative questionnaire was developed covering the different criteria used in biosimilar development and registration process. Eleven regulatory agencies from BRICS-TM and ACSS (Australia, Canada, Switzerland and Singapore) countries were invited to take part in this study. Data processing and analysis was carried out using descriptive statistics for quantitative data and content analysis to generate themes for qualitative data. Results and Discussions: Nine of the 11 regulatory agencies recruited for the study completed the questionnaire. China and Singapore did not meet the deadline due to lack of resources. The organisational structure of BRICS-TM agencies revealed support from external assessors by most of these agencies in comparison with ACSS agencies. There was absence of reliance approach and participation in harmonisation activities across most BRICS-TM agencies. Despite alignment over biosimilarity, the mandate for in vivo non-clinical studies and additional local clinical studies in some of the BRICS-TM countries illustrates a lack of effective implementation of a step-wise approach. Adopting flexible regulatory standards in the sourcing of a RBP (Reference Biologic Product) by BRICS-TM similar to ACSS, will facilitate cost-effective development of biosimilar products. Conclusions: Comparative assessment of the biosimilar regulatory framework of BRICS-TM with ACSS agencies reveals the scope for enhancing efficiency of the regulatory approval process. To achieve this, BRICS-TM agencies should consider relying on reference agencies for alternative review mechanisms such as abridged or verification models, streamlined processes for providing scientific advice to developers and for waiving local clinical studies in-lieu of advanced scientific data.
Journal Article
A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US
To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.
Journal Article
Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement
When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.
The Optimising Efficiencies in Regulatory Agencies questionnaire, was completed by each of the NMRAs, which facilitates the assessment of GRevPs, which in turn affect the regulatory review processes.
Except for Cote d'Ivoire and Nigeria which are autonomous, the other five NMRAs operate within the administrative structure of their respective Health Ministry, to regulate medical products for human use, medical devices and diagnostics. Apart from Togo, the agencies receive partial funding from their governments as well as from regulatory fees. Population in the seven countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures in place to achieve quality in their review processes, although there were some remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality decision-making practices Ghana had implemented nine into a framework, Togo eight, Cote d'Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra Leone has partially implemented all ten and Senegal had not implemented any of the quality decision-making practices.
The study compared the organisation, GRevPs and quality decision-making processes of the NMRAs that actively participate in the ECOWAS-MRH initiative. Though some differences were identified with regard to organisation, a significant number of good review practice initiatives and quality decision-making practices were identified yet to be implemented to promote continuous improvement in the regulatory processes of the NMRAs.
Journal Article
Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges
The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical Abstracts database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA ( n = 22) and regulatory agencies ( n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for “collaborating” with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.
Journal Article