I. Community Responsibility and Action

Community is the key to successful reduction of alcohol and other drug abuse. Only at the community level can effective comprehensive response be developed that will reduce both supply of and demand for destructive psychoactive drugs. Only the community can bring about the fundamental societal changes in attitudes and behavior that will reduce significantly our demand for drugs. Only the community can develop and sustain accessible programs that over time, will successfully prevent, treat and control substance abuse. The interest of society is to create a safe, secure and healthy environment that is free of drug abuse among all its members.     

A Community Problem

Creating acceptance that substance abuse is a community problem requiring comprehensive response is crucial to this nation's “War on Drugs.” Only the community can bring about the fundamental changes, attitudes, and behaviors that will significantly reduce our demand for drugs. Only the community can develop and sustain accessible programs that, over time, will successfully prevent and control drug abuse to create a social environment in which all of its members can live.     

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.     

Postmortem forensic toxicology of trazodone

Trazodone is a popular antidepressant medication that has been available for approximately 30 years. It has a reputation as a safe drug with relatively few reported fatalities attributed solely to it. We review the pharmacology and forensic toxicology of trazodone and report toxicology and cause and manner of death in a series of 37 deaths in which trazodone was detected. Although the normal upper therapeutic blood concentration for trazodone is about 2 mg/L, fatalities are rarely attributed solely to it at blood concentrations below 9 mg/L. Considering the pharmacology of the drug, potential interactions between other drugs with serotonin reuptake properties need to be considered, as does the increased susceptibility to the toxic effects in patients with pre-existing heart disease. In the cases reviewed, none were attributed solely to trazodone, although trazodone was frequently present together with other serotonergic drugs, such as the selective serotonin reuptake inhibitors like fluoxetine and sertraline. Ten cases had blood trazodone concentrations above 2 mg/L. Of these cases, trazodone played a primary role in the death of three subjects, with blood concentrations all greater than 9 mg/L. We confirm the conclusions of others that trazodone is a relatively safe drug except in massive overdose, although its toxicity may be influenced by the presence of other drugs and underlying pathophysiology.     

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule,Treasury decision

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.     

转基因食品标签的消费者知情权比较研究

各国对转基因食品实施了不同的标签制度:强制标签与自愿标签。这两种标签制度分别建立在消费者需要知情和消费者有权知情的法理基础之上。需要知情是以产品为基础,确保消费者对客观真实的风险知情;而有权知情往往以生产过程和生产方法为基础,以风险预防为原则管理风险以减少消费者的感知风险。一个国家采取何种转基因食品标签制度,受到该国经济、文化和政治方面的影响。我国转基因食品标签立法在即,需要借鉴其他国家的立法经验,因地制宜地实施强制标签制度,以保障消费者知情权的实现。     

预防型民事责任

预防型民事责任,是指权利相对人的行为对权利人的权利已经造成损害并且还在继续侵害时,或者虽没有造成现实损害却存在造成侵害的危险时承担的一种民事责任。其目的是预防损害的继续或者是损害的发生。此种民事责任的承担,只需要证明权利人享有该权利,相对人的行为(作为或不作为)已经或者即将对权利人的权利造成侵害即可。责任人承担此种责任,采取的是无过错责任原则,不需要考虑责任人的过错。预防型民事责任不是不适用消灭时效,而是消灭时效在预防型民事责任中无法成就而无从适用。