FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine?

From the introduction: Just as slight variations between different sources of stem cells are crucial to understanding the real policy debate over when life begins under the law, slight permutations in the federal regulations and guidelines for stem cell research can have serious ramifications for advancing the science of stem cell research and therapeutic applications. As human embryonic stem cell ( ESC ) research has garnered widespread press coverage and generated enormous public controversy for over a decade, scientists and physicians have been finding generous amounts of less controversial, adult stem cells ( ASCs ) in an increasingly wide array of human tissue. These discoveries promise new and urgently needed therapies for patients but also pose novel challenges for regulators. This is especially so here, where many ASC therapies are emerging from the offices of practicing physicians instead of the laboratories of university or commercial research scientists

A Cautiously Pessimistic Appraisal of Trends in Toxics Regulation

This Article will draw on the one-hundred year history of drug regulation, which represents the most stringent regulatory system for chemicals of any kind. An examination of this broader experience exposes several commonalities and tradeoffs inherent in chemical regulation. It also offers a comparative perspective on the strategies used in the regulation of chemicals that suggests an upper limit for the stringency of regulation that is politically and scientifically viable. Two important insights emerge from this comparative analysis: (1) the ex ante-ex post dichotomy that is often drawn between common law and statutory law is overstated—if not simply false—for chemical regulation, and (2) for most chemicals tiered precautionary systems like those embodied in the Registration, Evaluation, and Authorization of Chemicals program ( REACH ) represent more of a change in rhetoric than a fundamental shift in substance over the status quo. Complementing the comparative historical analysis, this Article will provide an overview of recent scientific developments and their implications for toxics regulation. I expect the direct impacts to be marginal, at least for the foreseeable future. More importantly, given the limited resources available to toxics programs and the steep opportunity costs that these financial constraints impose, I will advocate that the Environmental Protection Agency ( EPA ) and National Institute for Environmental Health Sciences ( NIEHS ) invest modestly in toxicogenomic research. The emerging complexity of human genetics suggests that it would be prudent to allow research to progress in the biomedical sciences before focusing more intensely on toxicogenomics. The final part of the Article examines promising opportunities to improve the regulation of toxic substances, which is the subject of renewed interest in Congress and rising support from a broad cross-section of stakeholders. It will evaluate three primary policies: the virtues of tiered regulatory regimes, the potential role of post-marketing testing, and the value of complementary innovation-oriented policies to promote development of green chemistry processes and compounds. Each will be discussed with an eye toward emerging legislative efforts to amend TSCA

The future of North American trade policy: lessons from NAFTA

This repository item contains a single issue of the Pardee Center Task Force Reports, a publication series that began publishing in 2009 by the Boston University Frederick S. Pardee Center for the Study of the Longer-Range Future.This Task Force Report written by an international group of trade policy experts calls for significant reforms to address adverse economic, environmental, labor and societal impacts created by the 1994 North American Free Trade Agreement (NAFTA). The report is intended to contribute to the discussion and decisions stemming from ongoing reviews of proposed reforms to NAFTA as well as to help shape future trade agreements. It offers detailed proposals on topics including services, manufacturing, agriculture, investment, intellectual property, labor, environment, and migration. Fifteen years after NAFTA was enacted, there is widespread agreement that the trade treaty among the United States, Canada and Mexico has fallen short of its stated goals. While proponents credit the agreement with stimulating the flow of goods, services, and investment among the North American countries, critics in all three countries argue that this has not brought improvements in the standards of living of most people. Rather than triggering a convergence across the three nations, NAFTA has accentuated the economic and regulatory asymmetries that had existed among the three countries. [TRUNCATED

License to Deal: Mandatory Approval of Complex Financial Products

This Article explores the possibility of creating a system of mandatory pre-approval of complex financial products as an ex ante solution to the problem of systemic risk containment. Building on the concept of regulatory precaution borrowed from environmental and health law, and elements of pre-CFMA regulation of commodity futures, the Article outlines the broad contours of a new licensing scheme that would place the burden of proving social and economic utility of complex financial instruments on the intermediaries that structure and market them. Fundamentally a thought experiment, this proposal seeks to enrich the current policy debate by expanding the range of potentially plausible reform options

License to Deal: Mandatory Approval of Complex Financial Products

This Article explores the possibility of creating a system of mandatory pre-approval of complex financial products as an ex ante solution to the problem of systemic risk containment. Building on the concept of regulatory precaution borrowed from environmental and health law, and elements of pre-CFMA regulation of commodity futures, the Article outlines the broad contours of a new licensing scheme that would place the burden of proving social and economic utility of complex financial instruments on the intermediaries that structure and market them. Fundamentally a thought experiment, this proposal seeks to enrich the current policy debate by expanding the range of potentially plausible reform options

Strategies to Expand the U.S. Automated External Defibrillator Market

Despite defibrillation as the only effective treatment for sudden cardiac arrest (SCA), less than 15% of homes and public facilities have access to an automated external defibrillator (AED). In the United States, ineffective response to SCA cases occurring each year classifies it as a business problem for medical device manufacturing leaders, emergency responders, and bystanders. The purpose of this multicase study was to explore the marketing strategies AED manufacturing leaders use to expand their consumer customer base. Data were collected via in-depth interviews with a purposive sample of participants from 2 U.S. AED manufacturers on the east coast, 2 AED distributors, and 2 healthcare corporations in Texas, as well as a review of company materials. The framework for this study was product life cycle theory. Initial findings for expanding the U.S. AED market indicated that the market was not led by its manufacturers but by its distributors. This finding became an important theme noted from AED manufacturers in considering the consumer segment, an aftermarket from commercial marketing strategies. A common concern for the security of strategic marketing was evident across the AED manufacturer participants with reluctance to discuss business models and marketing plans. A congruent theme was the curtailment of open discussions regarding AED marketing strategies because of security and confidentiality risk. Also, limited number of approved AED manufacturers by the Federal Drug Administration minimizes AED access. Residual outcomes include improving the quality of life for the aging population while reducing the loss of the lives and costs of healthcare. Social implications include preventing sudden cardiac death by providing more accessibility of AEDs to baby boomers

Evaluating progress for the implementation of European Union nanotechnology strategies for safe design and responsible innovation of nanomaterials

This study examines the twin themes of risk governance and anticipatory governance to establish whether European Union (EU) risk governance instruments and others such as Responsible Research and Innovation( RRI ) are delivering on their promises for the safe and responsible development of nanomaterials(NM). This is an empirical study that conducts semi-structured interviews with cross-sectoral experts working within nanotechnologies to examine these issues. The main findings identify critical flaws in the principal chemical safety regulations(REACH) due to the lack of specificity for NM safety testing, and the scientifically contested EU definition for NM. Both of which undermine legal authority for enforcing regulatory compliance. Secondly, critical scientific gaps are evident that prevent comprehensive nano-risk analysis of the Environmental, Health and Safety (EHS) implications of NM production. Thirdly, there are indications that the nano industry is seeking to avoid engaging with either product regulation (REACH) or the social-ethical appraisal of NM production. Finally, compounding these deficiencies, the EU does not provide a bespoke overarching EU risk governance framework to scrutinise either the EHS effects or the wider social implications of current and future nano-innovation pathways. In this study, I proposes a novel solution for such a framework centred on a ‘Safety by Social Design’ approach. Its purpose is to facilitate responsible innovation by the societal alignment of nano innovation within an adaptive and integrative risk governance framework. This will serve the purpose of progressing the EU towards a more anticipatory governance approach for nano innovation