Back to first principles: a new model for the regulation of drug promotion

The US Food and Drug Administration''s (‘FDA’ or the ‘Agency’) current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency''s public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers’ First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications—(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications—that would be regulated consistent with the First Amendment and according to the strength of the government''s interest in regulating the specific communications included within each category. The New Model should address the FDA''s concerns related to off-label speech while protecting drug manufacturers’ freedom to engage in truthful and non-misleading communications about their products.     

Die Bedeutung institutionalistischer Ansätze für das Verständnis von Organisations- und Managementprozessen in multinationalen Unternehmen

Es ist auffällig, dass sich die sozialwissenschaftlich orientierte Organisationsforschung nur sehr wenig und theoretisch recht einseitig mit Multinationalen Unternehmen (MNU) als Organisationen beschäftigt. Organisationstheoretische Erklärungsmodelle, die das Verhalten in und von Organisationen jenseits technischer und ökonomischer Unternehmensumwelten erklären, sind daher eher rar und erst seit kurzem in einschlägigen Forschungsarbeiten zu finden. Ziel dieses Beitrages ist, die jüngere und vorwiegend englischsprachige Diskussion über den Einfluss von Institutionen und unterschiedlichen lokalen Rationalitäten auf Organisations- und Managementprozesse in MNU aufzuarbeiten. Im Folgenden werden die Grundlagen, wesentlichen Ansätze, Kernaussagen und Konsequenzen des europäischen und amerikanischen Institutionalismus dargestellt. Insbesondere wird der Beitrag die Bedeutung, aber auch Grenzen dieser beiden Ansätze für die Analyse von Veränderungsprozessen in Multinationalen Unternehmen skizzieren und evaluieren. Im Vergleich zum noch dominanten ?evolutionären Paradigma“ in der internationalen Managementforschung wird hier das alternative Erklärungspotenzial von sozialwissenschaftlichen Institutionentheorien herausgestellt und anhand von vier verschiedenen Aspekten diskutiert: dem Einfluss des Heimatlandes, der Macht und der Autonomie von Tochtergesellschaften sowie der Entstehung transnationaler sozialer Räume.     

Rebuilding a failed state: Liberia

This article argues for a combination of long-term engagement in providing security, culminating in training and mentoring of new security forces; a comprehensive approach to reintegrating ex-combatants that also benefits civilian host communities and helps to ensure that agricultural livelihoods are made viable; and the opening of a space for discussion of governance issues and revenue distribution that is supported by a revenue-collection trusteeship that takes some of the key areas of economic pillage out of the purview of the state and deposits state revenues transparently into the state's coffers, leaving it to a new breed of Liberian politicians to emerge.     

Technology transfer in a global economy

The emergence of new technologies is acting both as a driving force and an enabling factor to globalization. At the same time, these technologies are changing rapidly, shortening the life cycles of products and the underlying processes, and raising technology costs. Technology transfer from academic and scientific institutions has thus transformed into a strategic variable for companies and nations to cope with these challenges in a global economy. This article introduces the rationale for the special issue on the role of technology transfer in a global economy. The paper summarizes the main topics and themes covered by a selection of papers and keynotes presented at the annual conference of the Technology Transfer Society in 2011, as well as providing some pointers towards a future research agenda.     

The Rule of Law and Automation of Government Decision‐Making

Governments around the world are deploying automation tools in making decisions that affect rights and entitlements. The interests affected are very broad, ranging from time spent in detention to the receipt of social security benefits. This article focusses on the impact on rule of law values of automation using: (1) pre‐programmed rules (for example, expert systems); and (2) predictive inferencing whereby rules are derived from historic data (such by applying supervised machine learning). The article examines the use of these systems across a range of nations. It explores the tension between the rule of law and rapid technological change and concludes with observations on how the automation of government decision‐making can both enhance and detract from rule of law values.