Publications

This article reviews conventional approaches to environmental policy evaluation, outlines their presumed relevance to policy making and implementation, and points out the main reasons why they have been subject to challenge. It contrasts the conventional approach to environmental policy evaluation—which presumes the identity of the policy analyst is unimportant—with the “collaborative approach,” which emphasizes the need to engage relevant stakeholders (i.e., the users of policy analyses and those affected by them) in the process of environmental policy evaluation. The article also describes the emergence of “adaptive” approaches to resource management and sustainable development, and explains why they represent an important shift away from emphasizing “success” and “failure” in environmental policy making and toward ongoing public learning for purposes of improvement.

The articles selected for this volume draw on game theory, political science, psychology, sociology and anthropology to consider how the process of dispute resolution is altered, challenged and made more complex by the presence of multiple parties and/or multiple issues. The volume explores issues of coalition formation, defection, collaboration, commitments, voting practices, and joint decision making in settings of increasing human complexity. Also included are examples of concrete uses of deliberative democracy processes taken from new applications of complex dispute resolution theory and practice. The selected essays represent the latest theoretical advances and challenges in the field and demonstrate attempts to use dispute resolution theory in a wide variety of settings such as political decision making and policy formation; regulatory matters; environmental disputes; healthcare; community disputes; constitutional formation; and in many other controversial issues in the polity.

Sustainable development cannot be prescribed – rather, it results from conscious personal choices in government, business and NGOs. This thought-provoking book explores both the origins and future of the global sustainable development movement, and provides an original overview of the driving forces of sustainable development, including market forces and past and future trends.

Since passage of the first Prescription Drug User Fee Act almost 20 years ago, user fee negotiations and the legislative vehicles that authorize them have significantly changed the scope of FDA’s responsibilities. After PDUFA paved the way to the acceptance of user fees, programs were created for other FDA-regulated industries, such as medical devices, animal drugs, generic animal drugs and tobacco. Several additional user fee programs are on the horizon, such as those for generic human drugs and biosimilars. Are you and your organization ready to engage in a smart, educated manner?

There are many issues that reach across user fee programs. This book addresses: What approaches have been taken by FDA and the regulated industries to the various user fee programs? What can the history of prescription drug and medical device user fee negotiations tell us about future negotiations? What strategies worked in the past? What are the lessons learned that can be applied across all stakeholders?

Chapters explore the history leading to the first user fee program (PDUFA), the biopharmaceutical industry perspective on negotiating user fees, a first-of-its-kind view of negotiations from the FDA lens, a clear explanation of Congress’ role in enacting user fees, insight into how user fees expanded to medical devices, advice from professional negotiators on how to bring new tools to the negotiation table and overall lessons learned for all stakeholders.

This book serves as a guide to stakeholders preparing for any user fee negotiation, whether it’s for a new program, or reauthorization of an existing one. The book draws on the institutional knowledge of many of the most experienced user fee negotiators, affording a unique 360-degree view of the evolving nature of such negotiations; it offers practical insights not only for those at the negotiating table, but for anyone involved in helping to shape, analyze, monitor or understand user fee programs.