Definition of primary mode of action of a combination product. Final rule

The Food and Drug Administration (FDA) is amending its combination product regulations to define "mode of action' (MOA) and "primary mode of action" (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.     

Paradigm intention

Antony Duff's recent account of intended action has aroused considerable interest, particularly amongst English commentators, as an attempt to provide criteria that might be utilised by a judge or legislator. While Duff's analysis is instructive, and although it may be desirable to find conditions capturing the central notion of intention in action, this paper demonstrates that the specific conditions proposed by Duff are unsatisfactory. They require extensive modification in order to circumvent a number of difficulties presented here.     

Intending to Aid

Courts and commentators are notoriously puzzled about the mens rea standards for complicity. Accomplices intend to aid, but what attitude need they have towards the crimes that they aid? This paper both criticizes extant accounts of the mens rea of complicity and offers a new account. The paper argues that an intention can commit one to an event’s occurrence without committing one to promoting the event, or making it more likely to take place. Under the proposed account of the mens rea of complicity, an accomplice must have an intention that commits him to the crime’s occurrence, but need not commit him to making it more likely that the crime occurs. The paper traces the implications of this view both for several difficult complicity cases, and for ongoing debates among philosophers of action about the necessary and sufficient conditions of joint agency.     

The Closeness Problem and the Doctrine of Double Effect: A Way Forward

A major challenge to the Doctrine of Double Effect (DDE) is the concern that an agent’s intention can be identified in such a fine-grained way as to eliminate an intention to harm from a putative example of an intended harm, and yet, the resulting case appears to be a case of impermissibility. This is the so-called “closeness problem.” Many people believe that one can address the closeness problem by adopting Warren Quinn’s version of the DDE, call it DDE*, which distinguishes between harmful direct agency and harmful indirect agency. In this paper, I first argue that Quinn’s DDE* is just as vulnerable to the closeness problem as the DDE is. Second, some might think that what we should therefore do is give up on intentions altogether and move towards some kind of non-state-of-mind, victim-based deontology. I shall argue against this move and explain why intentions are indispensable to an adequate nonconsequentialist theory. Finally, I shall propose a new way of answering the closeness problem.     

Necessity, Moral Liability, and Defensive Harm

A person who is liable to defensive harm has forfeited his rights against the imposition of the harm, and so is not wronged if that harm is imposed. A number of philosophers, most notably Jeff McMahan, argue for an instrumental account of liability, whereby a person is liable to defensive harm when he is either morally or culpably responsible for an unjust threat of harm to others, and when the imposition of defensive harm is necessary to avert the threatened unjust harm. Others may favour a purely noninstrumental account of liability: one that looks only to the past behaviour of the potentially liable person. We argue that both views are vulnerable to serious objections. Instead we develop and defend a new view of liability to defensive harm: the pluralist account. The pluralist account states that liability to defensive harm has at least two bases. First, if an attacker is morally or culpably responsible for an unjust attack then he has forfeited what we call his agency right, and in doing so he has made himself partially liable to defensive harm. Whether the attacker is fully liable to defensive harm depends, however, on whether the imposition of defensive harm would infringe a different right held by the attacker: his humanitarian right. Humanitarian rights are rights to be provided with urgently needed resources or to be protected from serious harms when others can do so at reasonably low cost. We argue the pluralist account avoids the objections to which the instrumental and noninstrumental views are vulnerable, coheres with our intuitive reactions in a wide range of cases, and sheds new light on the way different rights combine to determine a person??s liability to suffer harm.     

从“三鹿事件”看我国行政不作为赔偿的法律空间——兼论《国家赔偿法(修正案草案)》的相关规定

现行法律未明文规定的行政不作为,但通过一定的法律解释方法,可以将其纳入我国现有的行政诉讼受案范围和行政赔偿范围。在行政行为是否构成实定法下的行政不作为这个前提性问题上,是无法同样运用法律解释的方法"推而衍之"的,即无法通过法律解释的方法释放出空间,这样,在修改《国家赔偿法》的时候,引入保护规范理论就是一个可行的解决方案。     

Can Saying Something Make It So? The Nature Of Seditious Harm

In this paper, I redress an analytic deficit in debates about sedition by providing an explanatorily account of the relation between speech and action using speech act theory as developed by J.L. Austin. The specific focus will be on speech acts advocating violence against the state, in the form of religious sermons preaching violent jihad or glorifying acts of terrorism. This philosophical account will have legal consequences for how we classify speech acts deemed to be dangerous, or to cause harm. It also suggests that because speech can constitute action or conduct in certain circumstances, sedition laws, in principle, might be defensible, but not in their current form.     

U.S. Army Corps of Engineers v. Hawkes Co.: Supreme Court Expands Rights of Regulated Parties to Challenge Agency Decisions

This article analyzes the potential impacts of the Supreme Court's recent decision in U.S. Army Corps of Engineers v. Hawkes Co. Prior to this decision, federal agency action that merely provided information could not be challenged because of the Administrative Procedure Act allowed parties to challenge only “final agency action.” The Court recognized that some actions that merely provide information can be final because they have legal consequences. To understand the extent to which the Hawkes decision expands the right to challenge agency action, the article compares the Hawkes decision with the Court's decision in Sackett v. Environmental Protection Agency, where the Court also discussed the issue of “final agency action.” The article concludes that the Court's reasoning regarding what type of consequences make an action “final” is the key to understanding what regulatory action can now be challenged.     

The Good,the Bad,and the Klutzy: Criminal Negligence and Moral Concern

One proposed way of preserving the link between criminal negligence and blameworthiness is to define criminal negligence in moral terms. On this view, a person can be held criminally responsible for a negligent act if her negligence reflects a deficit of moral concern. Some theorists are convinced that this definition restores the link between negligence and blameworthiness, while others insist that criminal negligence remains suspect. This article contributes to the discussion by applying the work of ethicist Nomy Arpaly to criminal negligence. Although not interested in legal issues herself, Arpaly has a well-developed theory of moral agency that explains moral concern in terms of responsiveness to moral reasons. Introducing her work to the ongoing scholarly debate will be helpful for two reasons. First, while a definition of negligence in terms of moral concern is recognized as one proposed solution to the negligence–blameworthiness problem, authors promoting it have yet to give a systematic account of moral concern and its relation to blame. Borrowing Arpaly's account will help clarify the idea of moral concern so that both proponents and critics of a concern approach to negligence can have a better-defined debate. Second, her theory of blameworthiness is especially suited to defending the blameworthiness of negligent actions, because it does not have recourse to a special quality of choice or self-control that must be active to render conduct blameworthy. To make this second advantage clear, the article argues that reliance on choice or self-control problematizes blameworthiness for negligence. Those who wish to defend blameworthiness for negligent acts should base their work on an account of moral agency that does not rely on either choice or self-control to explain when an action is blameworthy.     

Removal of regulations regarding certification of antibiotic drugs; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.     

Classifying Type of Child Maltreatment: Does the Source of Information Make a Difference?

To determine whether antecedents or consequences of maltreatment differ by type of maltreatment, researchers must address the question of how to classify type of maltreatment. However, maltreatment rarely occurs in the pure forms desirable for research. Children often experience multiple forms of maltreatment at one time or experience different types of maltreatment at different times. This paper examines six different methods for classifying type of maltreatment in a sample of cases reported to a state protective service agency. The greatest shifts in type of maltreatment group membership occurred when the definition was expanded from a single maltreatment report to include prior history of maltreatment for the study child and present and prior maltreatment for siblings. Multiple forms of maltreatment increased as more maltreatment history was taken into account. Regardless of the classification source, the most frequent multiple type was the combination of physical abuse and neglect.     

Medical device reporting--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers of medical devices, including diagnostic devices, to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDA is taking this action under the Medical Device Amendments of 1976. The final rule is intended to assure that FDA is informed promptly of all serious problems or potentially serious problems associated with marketed devices. FDA is the principal public health agency responsible for ensuring that devices are safe and effective. To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public's exposure to this risk. Depending on the facts and circumstances, these steps could include contacting the manufacturer or importer of the device and monitoring its voluntary actions to respond to the problem, initiating a consumer or user education program, or initiating regulatory action, such as injunction, seizure, or other enforcement action.     

受欺诈行政行为的违法性和法律责任——以行政机关为视角

本文在简要梳理了法院对受欺诈行政行为的审查后,以行政机关为视角,认为基于相对人欺诈而实施的行政行为具有违法性,但判断导致这种违法性的过错标准应当是法律上对义务的配置,因而行政行为的违法与行政机关的过错并不完全一致;受欺诈行政行为引发的法律责任的确定必须以主观过错和客观违法为要件而不能仅仅以客观违法为要件。本文以此为基础,主张在我国进行四个方面的法制改革,即确立无效行政行为制度,改革仅以违法为构成要件的行政赔偿制度和不以主观过错为要件的行政执法责任制,完善实施授益行政行为的事前和事后程序制度。     

Removal of regulations regarding certification of drugs composed wholly or partly of insulin; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of drugs containing insulin and make conforming amendments to other sections of the agency's regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act.     

Medical devices; reclassification of the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the knee joint femorotibial (unicompartmental) metal/polymer porous-coated uncemented prosthesis. Final rule

The Food and Drug Administration (FDA) is announcing that it has reclassified two fixed-bearing knee joint prostheses, the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace a knee joint, and the knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace part of a knee joint. FDA has reclassified the devices from class III (premarket approval) into class II (special controls). The special control that will apply is a guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The agency is reclassifying these devices into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the devices, and there is sufficient information to establish special controls. The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the devices.     

Medical Devices; hematology and pathology devices; reclassification of automated blood cell separator device operating by filtration principle from class III to class II. Final rule

The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse reactions to be filed by the manufacturer for a minimum of 3 years. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is reclassifying the automated blood cell separator devices operating by filtration principle into class II (special controls) because special controls, in addition to general controls, are capable of providing a reasonable assurance of safety and effectiveness of the device.     

行政处罚中择一重罚规则的体系化阐释

择一重罚规则的适用面临执法管辖权与高额罚款权归属主体不一的难题。综合执法制度可以部分解决该问题,在综合执法之外,则需分情况适用不同的解决方案。在识别“罚款数额高的规定”时,应根据法定罚的上限而非决定罚来比较罚款的轻重。根据法定罚款额高的法律作出的决定罚,其数额不能低于法定罚款额低的法律所规定的罚款下限。行政机关错误适用择一重罚规则作出罚款决定,人民法院可以作出变更判决,但变更判决要受禁止不利变更规则的约束。在被人民法院判决撤销并责令重作的情形中,行政机关加重对当事人的罚款,通常应证明其加重罚款没有恶意,因裁量逾越被判决责令重作的除外。     

Exclusionary Reasons and the Explanation of Behaviour

Abstract .
Legal philosophy must consider the way in which laws function as reasons for action. "Simple positivism" considers laws as merely reasons in the balance of reasons. Joseph Raz, as a representative of "sophisticated positivism," argues that laws are exclusionary reasons for action, not merely reasons in the balance of reasons. This paper discusses Raz's arguments for his view. The Functional Argument provides no more reason for positivism than against it. The Phenomenological Argument is best supported by an account of how character traits function in explaining behaviour. But then the distinction between exclusionary reasons and expressive reasons is obliterated. Legal positivism cannot absorb laws as expressive reasons for action. Raz's positivism implies the correctness of an anti-positivistic legal theory.     

An Ecological Study of Nonresidential Services for Battered Women Within a Comprehensive Community Protocol for Domestic Violence

This paper is an ecological study of services provided to 392 battered women under a comprehensive domestic violence protocol. It focuses on microsystemic interactions between battered women and battered women's services and legal systems. We examine the relationships between women's receipt of services from a battered women's agency, receipt of protective orders, and completion of prosecution of batterers. We also explore the associations between women's receipt of services and protective orders and their partners' subsequent arrests and police contacts. We use open-ended interviews with battered women and with staff of the battered women's agency to expand and illustrate the quantitative data. The analysis shows that when a woman received battered women's services or had a protective order, a completed court case was more likely and numbers of arrests rose. We found that these associations were strongest when women received both battered women's services and at least one protective order.