Christa Altenstetter

The City University of New York (Graduate Center and Queens College)
Ph.D./MA Program in Political Science

365 Fifth Avenue
PhD/MA Program in Political Science
New York, NY
10016
caltenstetter@gc.cuny.edu

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To examine and compare the reforms of medical devices regulation at the US FDA and the European Union.

Citation:
Altenstetter, Christa. 2011. "Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking." Law and Policy, 33(2): 227-255.
Abstract: Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders - device makers and regulators - is a complex task. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluations and premarket checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients.
Citation:
Altenstetter, Christa. 2012. "Medical Device Regulation in the European Union, Japan and the United States. Commonalities, Differences and Challenges." Innovation - The European Journal of Social Science Research, 25(4).
Abstract: The evolution and diversity of institutions across the United States, the EU and Japan, and the timing of the medical device framework splitting off from the drug regulatory framework, are striking. Regulatory agencies face a new landscape: the combination of industry-paid user fees and appropriations, and a general pro-business climate coupled with dramatic advanced in medical technology, shortage in skilled experts trained in the latest state-0f-the-art science, and necessary legal and administrative changes. This paper seeks explanations for the complex structure of medical device regulation by focusing on the meaning of the "life cycle" concept, opportunities for patient voices, and the scope of and potential for conflicts of interest of, industry, physicians, scientific advisors and reguatory authorities. The paper concludes that the initial international differences between medical device frameworks tend to be mitigated by voluntary global harmonization, but the actual effective integration into the national regulatory framework significantly depends on each nation's and the EU's embedded norms, rules and procedures, and politics.
Citation:
Altenstetter, Christa and Govin Permanand. 2007. "EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective." Review of Policy Research. 24(5): 385-405.
Abstract: This paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as "competing" objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same constitutional rules and constraints at the EU level and both being central to the delivery of high-quality health-care in Europe, there are a surprising number of differences between the regulatory frameworks. This stems in part from their different "lauch" times, hence different institutional conditions of regulation and commensurate political climates, as well as reflecting different goals among member-state and EU-level policy makers, are among the paper's main conclusion.
Citation:
Altenstetter, Christa. 2013. "US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States." European Journal of Risk Regulation, 4: 443-464.
Abstract: By drawing on interdisciplinary studies, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.
Citation:
Altenstetter, Christa. 2014. Medical Technology in Japan. The Politics of Regulation. New Brunswick: Transaction Publishers.
Abstract: Japan is suffering from a "device gap." Compared to its American and European counterparts, Japan lags in adopting innovative medical devices and making new treatments and procedures available to its patients. Many blame the government and bureaucracy for Japan's delayed access to modern medicine and medical devices. Christa Altenstetter examines the contextual social, historical, and political conditions of Japan's medical field to make sense of the state of the country's medical profession and its regulatory framework. She explores the development of regulatory frameworks and considers possibilities for eventual reform and modernization. More specifically, Altenstetter looks into how physicians and device companies connect to the government and bureaucracy, the relationships connecting Japanese patients to their medical system and governmental bureaucracy, and how the relationships between policymakers and the medical profession are changing. The issues addressed here are becoming increasingly relevant as numerous countries in Asia, Latin America, and Central and Eastern Europe are only now beginning to regulate medical Technology, following the lead of the US and the European Union. Those interested in global medicine and Asian studies will find this book both informative and compelling.
Citation:
Altenstetter, Christa. 2008. Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France. Transaction Publishers.
Abstract: Excerpts from Dr. Nupur Chowdhury's recent review to be published in EJRR (2011):"...The book brings in a distinct and largely missing voice in the academic literature on medical products. The book primarily looks at the evolving institutional scene of French medical device regulation and links this up with the regulatory developments in Europe." The book would appeal to both generalists and specialists alike from political science, law and regulatory studies and sociology.
Citation:
Altenstetter, Christa, and James W. Bjorkman. 1997. Health Policy Reform, National Variations and Globalization. Palgrave Macmillan. Series: Advances in Political Science.
Abstract: The book is an edited volume of national case studies (Brazil, Germany, Israel and The Netherlands, France, Britain, Canada, Poland and Czech Republic).

Substantive Focus:
Governance
Health Policy SECONDARY
Comparative Public Policy PRIMARY

Theoretical Focus:
Policy History PRIMARY
Policy Process Theory SECONDARY
Agenda-Setting, Adoption, and Implementation

Keywords

MEDICAL DEVICES REGULATION AND GOVERNANCE CROSS-NATIONAL COMPARISON RISK REGULATION MEDICAL REGULATION MEDICAL GOVERNANCE MEDICAL GOVERNANCE GLOBAL HARMONY INSTITUTIONALIST APPROACH REGULATION GOVERNANCE