Lack of Transparency in the Premarket Approval Process for Aquadvantage Salmon

After a lengthy premarket approval process, the Food and Drug Administration (FDA) has just deemed AquAdvantage Salmon, a fast-growing, genetically engineered salmon, safe for human consumption. AquAdvantage Salmon is the first genetically engineered animal designed for human consumption to go to market in the United States. Because there have been no significant changes to the statutory or regulatory framework governing agricultural biotechnology since it was established in the 1980s, the FDA reviews applications of genetically engineered animals under the New Animal Drug Application (NADA) provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA’s treatment of genetically engineered food as a new animal drug has been criticized due to potential environmental and human health risks, and because of a lack of transparency throughout the regulatory process. After providing an overview of the premarket approval process, this Issue Brief argues that even under the NADA provisions, the FDA’s premarket approval risk assessment should be more transparent. In particular, the justification for trade secret status of relevant biotechnology is undermined, if not extinguished, by the need for public consideration of the biotechnology’s safety and effectiveness after a certain time in the approval process. Furthermore, the comment period prior to advisory committee meetings should be lengthened to allow for greater scientific input on safety and effectiveness, and an independent body should be created to communicate with the public about food safety

ImageSieve: Exploratory search of museum archives with named entity-based faceted browsing

Over the last few years, faceted search emerged as an attractive alternative to the traditional "text box" search and has become one of the standard ways of interaction on many e-commerce sites. However, these applications of faceted search are limited to domains where the objects of interests have already been classified along several independent dimensions, such as price, year, or brand. While automatic approaches to generate faceted search interfaces were proposed, it is not yet clear to what extent the automatically-produced interfaces will be useful to real users, and whether their quality can match or surpass their manually-produced predecessors. The goal of this paper is to introduce an exploratory search interface called ImageSieve, which shares many features with traditional faceted browsing, but can function without the use of traditional faceted metadata. ImageSieve uses automatically extracted and classified named entities, which play important roles in many domains (such as news collections, image archives, etc.). We describe one specific application of ImageSieve for image search. Here, named entities extracted from the descriptions of the retrieved images are used to organize a faceted browsing interface, which then helps users to make sense of and further explore the retrieved images. The results of a user study of ImageSieve demonstrate that a faceted search system based on named entities can help users explore large collections and find relevant information more effectively

The New Politics of US Health Care Prices: Institutional Reconfiguration and the Emergence of All-Payer Claims Databases

Prices are a significant driver of health care cost in the United States. Existing research on the politics of health system reform has emphasized the limited nature of policy entrepreneurs’ efforts at solving the problem of rising prices through direct regulation at the state level. Yet this literature fails to account for how change agents in the states gradually reconfigured the politics of prices, forging new, transparency-based policy instruments called all-payer claims databases (APCDs), which are designed to empower consumers, purchasers, and states to make informed market and policy choices. Drawing on pragmatist institutional theory, this article shows how APCDs emerged as the dominant model for reforming health care prices. While APCD advocates faced significant institutional barriers to policy change, we show how they reconfigured existing ideas, tactical repertoires, and legal-technical infrastructures to develop a politically and technologically robust reform. Our analysis has important implications for theories of how change agents overcome structural barriers to health reform

Best practice in undertaking and reporting health technology assessments : Working Group 4 report

[Executive Summary] The aim of Working Group 4 has been to develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development. Health technology assessment (HTA) is a multidisciplinary activity that systematically examines the technical performance, safety, clinical efficacy, and effectiveness, cost, costeffectiveness, organizational implications, social consequences, legal, and ethical considerations of the application of a health technology (18). HTA activity has been continuously increasing over the last few years. Numerous HTA agencies and other institutions (termed in this report “HTA doers”) across Europe are producing an important and growing amount of HTA information. The objectives of HTA vary considerably between HTA agencies and other actors, from a strictly political decision making–oriented approach regarding advice on market licensure, coverage in benefits catalogue, or investment planning to information directed to providers or to the public. Although there seems to be broad agreement on the general elements that belong to the HTA process, and although HTA doers in Europe use similar principles (41), this is often difficult to see because of differences in language and terminology. In addition, the reporting of the findings from the assessments differs considerably. This reduces comparability and makes it difficult for those undertaking HTA assessments to integrate previous findings from other HTA doers in a subsequent evaluation of the same technology. Transparent and clear reporting is an important step toward disseminating the findings of a HTA; thus, standards that ensure high quality reporting may contribute to a wider dissemination of results. The EUR-ASSESS methodologic subgroup already proposed a framework for conducting and reporting HTA (18), which served as the basis for the current working group. New developments in the last 5 years necessitate revisiting that framework and providing a solid structure for future updates. Giving due attention to these methodologic developments, this report describes the current “best practice” in both undertaking and reporting HTA and identifies the needs for methodologic development. It concludes with specific recommendations and tools for implementing them, e.g., by providing the structure for English-language scientific summary reports and a checklist to assess the methodologic and reporting quality of HTA reports