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ABSTRACT: Federal oversight of nanobiotechnology in the United States has been fragmented and incremental. The prevailing approach (at FDA, OSHA, and other key agencies) has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach is inadequate for this complex and convergent technology and may indeed undermine its promise. This technology demands a new, more dynamic approach to oversight. In proposing a new oversight approach to nanobiotechnology, this article breaks new ground. The authors go beyond passive to active nanomaterials; focus on the specific challenges of nanobiotechnology; anticipate scientific convergence (marrying nanotechnology, biotechnology, information technology, and cognitive sciences); address dynamic oversight and regulation, cognizant of “new governance” approaches; and develop U.S. oversight recommendations with an eye to transnational and international approaches. The article proposes a new oversight framework with three essential features: (a) oversight can move dynamically between “soft” and “hard” approaches over time as information and nano-products evolve; (b) oversight integrates inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) oversight features an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. This proposed framework derives from detailed case analysis of key oversight regimes relevant to nanobiotechnology using a methodology grounded in expert elicitation and multi-criteria assessment, as described here and elsewhere. The proposal is informed by inputs from experts in academia, industry, NGOs, and government.
Journal of Nanoparticle Research 01/2011; · 3.29 Impact Factor
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Jordan Paradise
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ABSTRACT: This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010. The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are "biosimilar" to an existing marketed product. The brief introduction will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA's development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained with this Book of the Seton Hall Law Review.
Seton Hall law review 01/2011; 41(2):501-10.
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Susan M. Wolf,
Frances P. Lawrenz,
Charles A. Nelson,
Jeffrey P. Kahn,
Mildred K. Cho,
Ellen Wright Clayton,
Joel G. Fletcher,
Michael K. Georgieff,
Dale Hammerschmidt,
Kathy Hudson, [......],
Vivek Kapur,
Moira Keane,
Barbara Koenig,
Bonnie LeRoy,
Elizabeth McFarland, Jordan Paradise,
Lisa Parker,
Sharon Terry,
Brian Van Ness,
Benjamin Wilfond
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ABSTRACT: Tremendous debate surrounds the question of whether researchers owe back to human subjects information about incidental findings of potential clinical and reproductive importance to the individual. Historically, law, ethics, and practice have drawn a bright line between the duties of clinicians and the duties of researchers, imposing on researchers no duty to return information of clinical importance. Indeed, bioethics and health law are built on a dichotomy between clinical care (the domain of the doctor-patient relationship) and research (the domain of the researcher-subject relationship). Yet the debate over whether researchers have any duty to return incidental findings (and the related debate over whether they have a duty to return individual research results) challenges that fundamental dichotomy. This article offers analysis and recommendations from a two-year project funded by the National Institutes of Health (NIH) and led by Susan M. Wolf (Principal Investigator) to determine how to manage incidental findings (IFs) in human subjects research, focusing on genetic and genomic research, with comparison to imaging research. This is the first national project funded by NIH on this issue. IFs are defined as findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. IFs are frequently discovered in conducting research and can hold life-and-death importance (as when researchers stumble upon a genetic variant predicting life-threatening response to a commonly used anesthetic). The article argues that researchers have an obligation to address the possibility of discovering IFs and articulate how IFs will be managed. This information should be reflected in the researcher’s protocol and communications with the IRB, as well as in consent forms and communications with research participants. The article recommends a pathway for researchers to follow in addressing IFs. It categorizes IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. This is the first comprehensive analysis and major set of recommendations on how to handle incidental findings in human subjects research including genomic research. It is the centerpiece of a symposium issue including sixteen articles from a multidisciplinary group of top scholars on this pressing issue.
Medical-Legal Studies eJournal. 12/2010;
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ABSTRACT: In 1980, the United States Supreme Court in Diamond v. Chakrabarty authorized the patenting of a genetically-engineered living organism. The Court indicated that this was an invention, not a product of nature and said that “[t]he laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Nevertheless, in an erroneous application of the case, the United States Patent and Trademark Office (USPTO) began allowing patents to be issued on genetic sequences when “isolated from their natural state and purified.” The proponents of gene patents claim that legal precedents allowing the patenting of isolated and purified products of nature justify the patenting of genetic sequences. They claim that the remaining genetic sequence is an “invention” since it has been “isolated” (taken out of the body) and “purified” (had non-coding regions removed). In this project, we tested that claim by analyzing U.S. court cases at all levels that either specifically or indirectly address the products of nature doctrine (including all cases that specifically claim that isolation and purification transforms an unpatentable product of nature into a patentable invention). In analyzing the patent cases, we assessed the application of the products of nature doctrine from the late-1800s until today and undertook research to identify the product or process claimed in each patent and the relationship of that product or process to something that occurred in nature.
Legal History eJournal. 06/2010;
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The Journal of Law Medicine & Ethics 12/2009; 37(4):543 - 545. · 1.22 Impact Factor
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The Journal of Law Medicine & Ethics 01/2009; 37(4):543-5. · 1.22 Impact Factor
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ABSTRACT: This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.
The Journal of Law Medicine & Ethics 01/2009; 37(4):598-624. · 1.22 Impact Factor
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ABSTRACT: The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH). All can learn from assessment of the successes and failures of past oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation (NSF) aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms (GEOs) in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight.
The Journal of Law Medicine & Ethics 01/2009; 37(4):688-705. · 1.22 Impact Factor
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ABSTRACT: Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty-six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty-eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach "integrated oversight assessment" and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence-supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.
Risk Analysis 10/2008; 28(5):1197-220. · 2.37 Impact Factor
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ABSTRACT: Oversight systems specific to nanotechnology have not yet been created; stakeholders, government, industry, academia, and the public are debating whether and how to craft such systems and address emerging safety, social, and ethical issues. The United States has no coordinated policy for oversight of the products and applications of nanotechnology and uncertainty prevails over how existing general regulatory regimes and industry standards apply to emerging nanotechnologies. Empirical assessment of health and environmental risks is still in process. At the same time, public understanding of nanotechnology is rudimentary and public concern exists. This article focuses on nanobiotechnology, which most directly raises questions of how oversight can address safety and efficacy, outlines the current debate on oversight in the United States, suggests why deliberate development of oversight strategies is important, and recommends how to develop them.
Public Health Law & Policy eJournal. 03/2008;
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Food and drug law journal 02/2008; 63(2):407-20. · 0.76 Impact Factor
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ABSTRACT: Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.
The Journal of Law Medicine & Ethics 02/2008; 36(2):361-83, 214. · 1.22 Impact Factor
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Susan M Wolf,
Frances P Lawrenz,
Charles A Nelson,
Jeffrey P Kahn,
Mildred K Cho,
Ellen Wright Clayton,
Joel G Fletcher,
Michael K Georgieff,
Dale Hammerschmidt,
Kathy Hudson, [......],
Vivek Kapur,
Moira A Keane,
Barbara A Koenig,
Bonnie S Leroy,
Elizabeth G McFarland, Jordan Paradise,
Lisa S Parker,
Sharon F Terry,
Brian Van Ness,
Benjamin S Wilfond
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ABSTRACT: No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.
The Journal of Law Medicine & Ethics 02/2008; 36(2):219-48, 211. · 1.22 Impact Factor
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ABSTRACT: Biohistorical analysis involves using historic specimens of human remains or human material extracted or derived from historical artifacts to gather evidence about specimens that are identifiable or at least attributed to a historic figure at the time of the research. Biohistorical studies are being undertaken for myriad reasons, such as identification and authentication of remains, investigation into alleged criminal behavior, investigation into medical or psychological conditions, and even for purposes of commercialization. This article analyzes federal statutes, case law, and codes and guidelines from twenty-six professional organizations and societies informative to the field of biohistory. We surveyed the field, identified deficiencies in oversight and guidance, investigated prior biohistorical studies, and concluded that greater consideration of a variety of scientific, ethical and legal issues is needed. The article uses legal and ethical precedents to propose ways to avert abuses in five key areas we identified as important: (1) promotion of research; (2) access to samples or artifact; (3) scientific integrity and dissemination of results; (4) informed consent and rights of participants; and (5) avoidance of conflicts of interest. Throughout, we identify critical questions, concerns, and considerations for biohistory. We conclude with suggestions for development of guidance in this area.
Legislation & Statutory Interpretation eJournal. 01/2008;
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Science 01/2007; 314(5804):1395-6. · 31.20 Impact Factor
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ABSTRACT: There is significant domestic and international opposition to gene patents based on the fact that gene patents deter medical research and health care, as well as the policy position that genes are an inherent product of nature. Yet, equally troubling is the fact that gene patents have been issued by the U.S. Patent & Trademark Office that are problematic with respect to existing federal patent law. The authors of this Policy Forum describe their study, which examined issued gene patents covering a variety of genetic diseases and described ways in which many claims fell short of USPTO patentability requirements.
Property, Citizenship, & Social Entrepreneurism eJournal. 04/2006;
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ABSTRACT: While debate continues as to whether genetic sequences, which many argue represent natural phenomena rather than inventions, should be subject to standard patent protections, issuance of patents that claim DNA sequences remains common practice. In an attempt to insulate researchers from patent claims that could hinder scientific progress, many countries have provided general exemptions for scientific research. However, there is no international consensus about the extent of required protections, and even existing exemptions vary widely in clarity and are limited in practical application. We believe that gene patents raise several unique issues that are inadequately handled by the current research exemptions.
Nature Reviews Genetics 03/2006; 7(2):148-54. · 38.08 Impact Factor
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Science 04/2005; 307(5715):1566-7. · 31.20 Impact Factor
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Yale journal of health policy, law, and ethics 02/2005; 5(1):403-12.
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Lori B Andrews,
Nancy Buenger,
Jennifer Bridge,
Laurie Rosenow,
David Stoney,
R E Gaensslen,
Theodore Karamanski,
Russell Lewis, Jordan Paradise,
Amy Inlander,
David Gonen
Science 05/2004; 304(5668):215-6. · 31.20 Impact Factor
