Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to issue new regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drug, including biologics, and devices. The proposal, which would implement the dissemination provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), would describe the content of and establish procedures for a manufacturer's submissions to FDA before it may begin disseminating information on the new use. The proposal also would describe how manufacturers seeking to disseminate new use information must agree to submit a supplement for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The proposal also would provide for requests to extend the time period for submitting a supplement for a new use, and it would describe how a manufacturer can seek an exemption from the requirement to submit a supplement. Additionally, the proposal would discuss FDA actions in response to manufacturer's submissions, corrective actions that FDA may take, and recordkeeping and reporting requirements.     

Automatic implantable cardioverter defibrillator rhythm strip data as used in interpretation of a motor vehicle accident

The automatic implantable cardioverter defibrillator (AICD) is an electronic device that monitors the rhythm of the heart and, upon detecting a life-threatening arrhythmia, shocks the heart in an attempt to restore a normal rhythm. The AICD will electronically store the information of the event. Later, the AICD can be "interrogated" and the information electronically retrieved, with a printout of the rhythm strip obtained. The interrogation is fairly simple and involves a magnetic device placed over the AICD, which in turn is connected to a portable computer, which, with specialized software, can deliver the information in a usable form. Not only can information about the most recent shock be obtained, but also information about previous shocks can be retrieved. This case presentation highlights how such preterminal information retrieved from an AICD helped to interpret the circumstances leading to a death--in this case, a fatal motor vehicle accident. Additionally, driving restrictions that may be placed on individuals with AICDs are discussed.     

Invocation of coercion context in compliance communication -- power dynamics in psychiatric care

This article draws on observations from ethnographic fieldwork to develop a theoretical understanding of the power dynamics in psychiatric care. The aim is to analyze how psychiatric clinicians solve compliance problems by invoking "coercion context". It is suggested that clinicians take a rather instrumental approach to laws regulating coercive intervention. Clinicians may invoke a coercion context even with voluntary patients. For example, they may use wordings that connote coercion, or they may make use of how treatment wards are set up to accommodate involuntary patients, thus stalling voluntary patients who cannot exit through locked doors. A coercion context can also be invoked to solve mundane practical problems, e.g. when clinicians talk about "coerced showers". The management of information and maintaining a suitable "awareness context" with regards to coercion is an essential feature in clinical attempts to achieve compliance from patients. In conclusion, the notion of coercion context helps explain the confusing findings from previous research about patients' apparent misconceptions of their formal legal status. Furthermore, it is argued that research that rely on decontextualised, objectifications of "coercion" risk to miss the meaning coercion is assigned in everyday clinical practice.     

辨认笔录证据能力问题研究——以新《刑事诉讼法》为视角

辨认笔录作为新型的证据种类为新《刑事诉讼法》所确认,在辨认程序缺乏立法规制的情况下,如何对其可靠性和合法性进行审查判断成为实践中的难题。"两院三部"联合制定的《死刑案件证据规定》初步确立了辨认结果的审查判断规则,为法庭审查和采信辨认证据提供了一定的根据。但是,在辨认录像制度、见证人在场制度以及警察出庭作证制度尚未有效确立的情况下,对具有"传闻证据"性质的辨认笔录采用书面审查的方法仍具有相当大的局限性,不但难以发现辨认过程中存在的程序瑕疵和程序违法问题,而且无法完成对辨认结果可靠性的实质审查任务。本文针对我国侦查实践中常用的列队辨认和照片辨认程序,提出了具体的审查内容和方法,对"暗示性辨认"提出了具有可操作性的判断规则。对于辨认结果证据能力的认定,可以借鉴美国的"总体情况规则",采用"可靠性"判断标准,对于违反辨认规则获得的辨认结果,并不当然否定其证据能力,当该结果获得了"真实性的情况保障"时,可以作为定案根据。     

反思与重构:我国商业秘密立法之完善

商业信息只有符合商业秘密的构成要件时,才能受到法律的保护。如何认定权利人主张的商业秘密是否存在容易产生争议。我国《反不正当竞争法》中关于商业秘密构成要件的规定应当删除"实用性"要件,以采取合理措施的程度作为评价"合理性"的标准,同时商业秘密的保护范围不应仅仅限定为"技术信息或商业信息"。     

关于公安“大情报”体系建设的实践与思考

公安"大情报"体系,是实现情报信息主导警务工作模式的重要载体。由于我国公安"大情报"体系建设正处于起步探索阶段,在机构设置、信息采集、情报共享、分析研判等方面还存在着一些不足,应从思想意识、机构设置、平台建设、工作机制等方面加以改进完善,以保障公安"大情报"体系建设的顺利进行。     

Mandatory Full-Cost Pricing in Public Services: The Case of the ‘Fantask’ Sentence

The sentence issued by the Court of Justice in the Fantask Case defined what sort of policies can be adopted by the Member States in connection with the fees for company registration without contravening the stipulations of Community legislation on raising capital. This article analyses how to set prices that comply with the sentence and at the same time generate efficient incentives. It first reviews to what extent the sentence meets the aims on which it is based. Second, it provides a guide for subsequent development of related jurisprudence. Third, it throws some light on how public authorities can set pricing policies.     

Distributive and procedural justice in the workplace

The interrelatedness of procedural and distributive justice has implications for organizational practice, especially in the area of performance appraisal. I explore these implications by first describing how procedures can influence perceptions of distributive justice: Procedural improprieties can bring to mind the possibility that a more just outcome might have been obtained if only more acceptable practices had been followed. Next I discuss a second form of interrelatedness — how distributive consequences can influence perceptions of procedural justice — by suggesting that the fairness of a procedure can be assessed in terms of its expected-value (typical or most probable) outcome. These points are illustrated by a discussion of howvoice, or the opportunity for employees to contribute information during the performance appraisal process, can affect both appraisal accuracy and perception of fairness.     

Review of the significance of various low force fractures in the elderly

The elderly are more prone to sustain fractures with low force injury because they have an increased incidence of falls, and because their bones are often more fragile secondary to osteoporosis and other conditions. Cases with fracture are routinely reported to medical examiner and coroner offices because fracture reflects traumatic injury. If a fracture is judged to be a significant factor in a person's death, then the manner of death must reflect how the injury was sustained, which is "accidental" in most of these cases. Often times the best information on the significance of a fracture is obtained from the deceased's physician, nurse, family, or close acquaintance. However, this valuable clinical information is not always available. When this is the situation, it would be helpful to know generally what fractures are likely to be associated with increased mortality, and for how long any excess mortality might be expected to persist. With this in mind, a search of the literature was performed to clarify clinically which fractures in the elderly population were associated with excess mortality and the duration that any excess mortality tended to persist.     

Digital provenance – interpretation,verification and corroboration

This paper defines the attributes that are required to provide ‘good’ provenance. The various sources that may be used to verify the provenance of digital information during the investigation of a Microsoft^® Windows^® based computer system are presented. This paper shows how provenance can be corroborated by artefacts which indicate how a computer system was connected to the outside world and the capabilities that it provided to a user. Finally consideration is given to a number of commonly used forensic tools and shows how they represent the provenance of information to an investigator.     

Understanding incidental findings in the context of genetics and genomics.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, "incidental" or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power afforded by new genomic analyses may lead to findings of statistical, but not necessarily clinical, significance. This paper addresses the issues to be considered in deciding whether and how to disclose "incidental" findings or other findings of clinical significance that arise in the course of human genomic and genetic research. What research results should be offered, and what should not be offered? For which research should individual results be offered to research participants, when should they be offered, how, and to whom?     

中国个人信息保护法草案若干问题

在个人信息保护法草案中,个人信息的定义应修改为"个人信息是能够单独或者与其他信息结合识别有生命的自然人的各种信息,不包括匿名化处理后的信息."并加一款体现"识别"+"关联"的立法思路的文字.个人信息处理的列名操作应该由七个变更为十一个,即收集、存储、加工、使用、交易、提供、公开、查阅、复制、更正、删除等.第六十九条匿名...     

Hart,Legal rules and palm tree justice

In this paper I defend a liberal theory about how legal rules can and ought to be interpreted. The theory emerges from a critical examination of H. L. A. Hart's influential views on the limited but unavoidable indeterminacy of legal rules. I begin with a brief sketch of Hart's early theory (as it is traditionally understood) offering various suggestions as to how it might usefully be modified. Next, several possible objections to my modifications are sketched and criticized. Finally, reasons are provided for supposing that the modified theory may well represent Hart's current position.     

Evaluating a Police Report

An evaluation system was developed for a police department using the MAUT-Baysian (Multiple Attribute Utility-Baysian Statistics) system of strategy evaluation. This system requires the elected officials, police department, and community to jointly establish the goals for the police department. These goals are then rank ordered from most important to least important. A weighting system is then established using the least important goal as the unit of measure to ensure goal consistency.

Both objective and subjective measures were developed to help assess the success of the Department meeting these goals. Measurements included comparisons between the Department and other similar departments on areas of concern, survey results of citizen and police attitudes, and observational information. After completing the data collection for the evaluation it is placed on a matrix to aid the decision maker get a complete overview of the Department. The array allows the manager to see quickly how the Department is doing on each goal and how the Department is doing as a whole.

The management implications for the system are extensive and powerful, since the manager can see how resource allocation or change can affect overall success. By shifting small resources from lower ranked to higher ranked goals major changes in police effectiveness can be accomplished.     

政府数据开放中个人信息保护的范式转变

政府数据开放并非静态的单一行为,而是动态的系统过程。借助数据生命周期理论,可以将政府数据开放解构为数据收集、转换、存储、公开和使用五个阶段。根据《个人信息保护法》和《数据安全法》确立的最新规则,个人信息保护风险可能同时存在于政府数据开放生命周期的各个阶段。然而,政府数据开放中现有的个人信息保护范式主要采取“基于结果的方法”,重点关注政府数据在公开时的状态,依靠技术性匿名化手段,难以有效应对政府数据开放中的个人信息保护风险。与此相对应,“基于过程的方法”与政府数据生命周期、个人信息保护的程序化和数据安全全流程管理相契合,可以弥补“基于结果的方法”的不足。通过将风险预防原则和程序、技术、经济、教育和法律等手段分散放置在政府数据开放生命周期的每个阶段,能够最大限度减少个人信息保护风险,在个人信息保护与政府数据开放之间实现动态平衡。     

Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks. A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.     

Social License and Environmental Protection: Why Businesses Go Beyond Compliance

This article examines the concept of the corporate "social license," which governs the extent to which a corporation is constrained to meet societal expectations and avoid activities that societies (or influential elements within them) deem unacceptable, whether or not those expectations are embodied in law. It examines the social license empirically, as it relates to one social problem–environmental protection–and as it relates to one particular industry: pulp and paper manufacturing. It shows try the social license is important, the circumstances in which it may encourage companies to go "beyond compliance" with regulation, how its terms are monitored and enforced, and how it interacts with what we term the regulatory and economic licenses. Overall, this research demonstrates that corporate environmental behavior cannot be explained purely in terms of instrumental threats and moral obligations to comply with the law, and that the increasing incidence of "beyond compliance" corporate behavior can be better explained in terms of the interplay between social pressures and economic constraints.     

Preserving human potential as freedom: a framework for regulating epigenetic harms

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between "nature" and "nurture" as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents' generation might affect our health now, even if we have not experienced the same exposures. In the same vein, current exposures could affect the health of not only individuals currently living but also future generations. Given the relative novelty of epigenetics research and the multifactorial nature of human development and disease causation, it is unlikely that conclusive proof can be established showing that particular exposures lead to epigenetic risks that manifest into specific conditions. Using the Capabilities Approach ("CA") developed by Amartya Sen and Martha Nussbaum, this article argues that epigenetic risk is not merely a medical issue, but that it more generally implicates the underlying fairness and justice of our social contract. For instance, how we develop mentally or physically has a tremendous impact upon our inherent capabilities and our set of life options. The CA prompts us to ask questions such as: (1) what impact do particular epigenetic risks have on our ability to exercise free choices; (2) are these risks avoidable; and (3) how are these risks distributed across society? Due to the complex nature of epigenetic risk, tort law is predictably incapable of addressing this harm. Further, while regulatory agencies possess the statutory authority to begin addressing epigenetic harms, currently these agencies are not attuned to measure or to respond to this type of harm. This article argues that it is imperative to initiate a regulatory framework to address epigenetic risk from specific substances even if conclusive proof of disease causation cannot be established. Shifting the burden of generating epigenetic risk data to producers of suspected harmful substances serves as a start. As information concerning epigenetic risks accrues, the regulatory response should evolve concurrently. As part of a dynamic policy-making approach our goals need to encompass the following: (i) promotion of knowledge in the scientific, legal, and public domains; (ii) assessment and modification of current regulations to address preventable risk; and (iii) an overarching commitment to protect human capabilities in an equitable manner.     

Vladimir Shapoval: "The CEC Is Destined to Be the Scapegoat"

"The law is harsh, but it is the law"—the well-known ancient Roman saying is entirely suitable as a brief synopsis of the Lb.ua interview with the chairman of the Central Election Commission (CEC), Vladimir Shapoval.

"Any electoral legislation, I emphasize, any, will always be 95 percent the product of political expediency. Always. This way gives them an advantage—so be it." This is how he calmly parried my emotional "How can the advantage of the strong be codified in the law (!), and the weak essentially have no chance? What can you do, how can it be?" "All this ‘whining and crying,’ say, the law is this and that in substance, I do not accept it. The laws were adopted—so we will follow them. You cannot get away from it," he added.

It might seem to someone who does not know Vladimir Nikolaevich that the chief vote-counting official is being clever, "covering up" the "distortions" of the authorities "at the local level." He is in fact speaking frankly. The chairman of the Central Election Commission formed on the eve of the 2007 preterm parliamentary elections by a "coalition"—a retired Constitutional Court of Ukraine (CCU) justice, and a doctor of legal sciences who is an active member of the High Council of Justice (HCJ), he can permit himself that. Shapoval contrives to call things by their names: "How the law is written is another matter. And its parts are written abominably," he states bluntly.

In view of this, my discussion with Shapoval—formally tied to the start of a local elections campaign—went far beyond the bounds of a discussion of the legislation on this topic, and even the specifics of the campaign. The more so as I had already discussed this in detail with CEC Deputy Chairman Andrei Magera. Vladimir Nikolaevich, without concealing his indignation, related just what the HCJ is really afraid of (and it turned out it was not at all, or more precisely not only, what they are portraying it to be). Relying on nine years of experience as a CCU justice, he elucidated the risks of the invalidation of the 2004 constitutional reform by the current Constitutional Court—"only those who have face can lose it." Sketching out the situation in the body politic, he summed up, "If the Party of Regions (PoR) does not win the local elections, many questions will arise."     

Psychological Testimony and the <Emphasis Type="Italic">Daubert</Emphasis> Standard

In the legal system, mental health professionals are now a primary source for expert information. Because potentially every psychologist might be drawn into a legal situation, competency requires accommodation of the nexus between the legal system and professional ethics and standards. Three particular Supreme Court cases create a framework for testifying about psychological information. This article reviews those three cases, defines the commitment to evidence-based (scientific) testimony, and explains how psychological ethics and standards should be accommodated. It reviews the major issues that psychologists face in Daubert admissibility challenges. Finally, it makes pertinent recommendations to help avoid the pitfall in dealing with court.