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Background: Cannabis policies should be relevant to communities most impacted by them. Home cultivation policies can engage people who grow cannabis and build on their motivation to supply a safe product. This paper aims to examine the laws pertaining to "home" (i.e. personal, small-scale) cannabis cultivation internationally and their different aspects, and to discuss the potential of these policies to be expanded into community-level cannabis supply models.Methods: We reviewed relevant laws and regulations in states/countries that legalised, decriminalised or applied other non-prohibitive approaches to home cannabis cultivation.Findings: Non-prohibitive approaches to home cannabis cultivation have been adopted in at least 27 jurisdictions. Twelve jurisdictions "de jure" legalised home cultivation (three U.S. states and Antigua and Barbuda legalised only home cultivation; six U.S. states, Uruguay and Canada legalised commercial sales as well). Eight states/countries "de facto" (Belgium, the Netherlands) or "de jure" decriminalised it (Czech Republic, Spain, Jamaica, and three Australian states). "De jure" depenalisation was in place in Chile and Brazil and recent court rulings yielded "de facto" depenalisation or "de facto" legalisation in five other jurisdictions (South Africa, Mexico, Colombia, Costa Rica and Georgia). Varying number of plants (per person and per property) and the circumstances of cultivation were in place. The key limitations of the regulations included (i) possession thresholds for the produce from home cultivations, (ii) rules about sharing the produce, and (iii) potentially disproportionate sanctions for non-authorised behaviours. Despite currently being limited, home cultivation policies might have the capacity to engage cannabis networks that already exist in the community and like that, enhance their participation in legitimate policy schemes.Conclusions: Rules around pooled cultivation and sharing could be made fit for purpose to accommodate community supply of cannabis. Home cultivation policies could serve as a basis for community-level cannabis supply models and as such, for more inclusive cannabis policies. [ABSTRACT FROM AUTHOR]

The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets. [ABSTRACT FROM AUTHOR]

Background: Canada has announced that it will legalize cannabis on October 17, 2018, and as a result of this impending drug law reform the need to develop prevention resources and drug education - in schools, in public health, and for parents - has emerged as a public concern and a policy priority. Set against this context, the aim of our paper is to amplify the parent perspective on preventing problematic adolescent cannabis use, but also to interrogate the idea of 'parents as the best prevention' that has taken hold in discussions about the potential consequences of legalization for youth.Methods: In 2016 we undertook an exploratory, qualitative interview study in Vancouver, British Columbia (n = 16) with parents of adolescents who had used cannabis. Building on our past research developing educator-led resources to support an open dialogue about cannabis in the classroom, in this study we asked parents about the supports and resources they needed to inform their discussions about cannabis with their adolescent children, as well the challenges they faced in responding to cannabis use when they believed it had become problematic.Findings: Across the interviews, parents mobilized discourses of risk and responsibility for preventing problematic cannabis use that appeared to reinstate individualizing accounts of substance use. Many echoed normative ideas about health, the risks of cannabis use, and 'good' parenting, sidestepping social inequities around drug use, and thus implicating parents and families as solely responsible for preventing adolescent drug use.Conclusion: Our analysis suggests how parents have been largely disempowered and unsupported when it comes to addressing adolescent drug use in the family context. Even as they expressed their awareness that formal supports and resources to assist them were lacking, parents also assigned blame to themselves - or to other parents - for 'failing' to prevent problematic cannabis use. [ABSTRACT FROM AUTHOR]

The legalisation of cannabis on the American continent in recent years has reinvigorated calls for cannabis law reform in many countries. Yet researchers have described potentially negative public health and social impacts of profit driven commercial markets for cannabis. Consequently, they have suggested exploring a number of alternative regulatory options, such as "not-for-profit" or "for-benefit" organisations. However, many of these new models are yet to be developed in detail. This paper presents a "community enterprise" model for recreational cannabis based on the alcohol licensing trusts which have existed in New Zealand for many decades. Alcohol licensing trusts are community-owned entities which operate alcohol retail outlets and return a portion of their profits back to local communities in the form of grants, loans and donations. The principal benefits of the "community trust" model are suppressing the commercial incentive to expand the market, establishing statutory obligations to distribute revenue back to the community, and establishing community governance over alcohol sales. The removal of a strong commercial incentive and community accountability may also contribute to lower levels of availability, higher prices and less harm. A further benefit is providing the local community with some oversight of a trust's commercial activities via community elections of the trust board and the ability to call a "community poll" to vote on the future existence of the trust. Our proposed community cannabis licensing trust model seeks to address some of the challenges experienced by alcohol licensing trusts in New Zealand, including the lack of general oversight and balancing the commercial and social aims of the trusts. A limitation of this model includes a lack of research and evaluation of the existing alcohol licensing trusts and further research in this area would inform the application of the model to cannabis. [ABSTRACT FROM AUTHOR]

In this paper, I present and criticize several historical arguments in favour of prohibition and criminalization of illicit psychoactive substances. I consider several versions of Charles Brent's argument from drug harms and an argument from addiction based on Kantian view on autonomy. My criticism will mainly rely on empirical evidence on drugs, drug use, and addiction. I think that in light of this evidence, all of the arguments lose their cogency or can be refuted altogether. Moreover, the evidence reveals an inconsistency in the international drug law framework. In conclusion, I therefore provide a general argument challenging the legitimacy of the existing distinction between licit and illicit drugs based on the inconsistency. [ABSTRACT FROM AUTHOR]

Highlights • 505(b)(2) NDA nonclinical programs could be streamlined and reduced. • Nonclinical data for the innovator drug could be relied upon. • 505(b)(2) NDAs reflect a streamlined drug approval pathway and approach. • Drug development costs and time pressures could be reduced while maintaining marketing exclusivity. In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially offering significant drug development and marketing advantages. Nonclinical testing programs for 505(b)(2) submissions are often reduced and, in some cases, are not even required. This paper provides an overview of the 505(b)(2) regulatory pathway with a focus on how nonclinical programs can be streamlined and accelerated. Teaser New drug applications (NDAs) using the FDA 505(b)(2) regulatory pathway can streamline and reduce nonclinical drug development requirements while potentially maintaining marketing exclusivity. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In September 1989, amid an emotional and ideological debate regarding problematic drug use in the United States and the 'war on drugs', RAND's Drug Policy Research Center (DPRC) was created through private foundation funds. The purpose of this new research center was to provide objective empirical analysis on which to base sound drug policy. Twenty years later, RAND's DPRC continues its work, drawing on a broad range of analytical expertise to evaluate, compare and assess the effectiveness of a similarly broad range of drug policies. More than 60 affiliated researchers in the United States and Europe make up the Center, which attempts to provide objective empirical analyses to better inform drug policies within the United States and abroad. This paper provides a look back at the creation, evolution and growth of the Center. It then describes how the Center operates today and how it has maintained its clear identity and focus by drawing on the analytical capabilities of a talented group of researchers from a broad range of academic disciplines. [ABSTRACT FROM AUTHOR]

The article presents the interview summary with epidemiologist Ingeborg Rossow who discusses her experience helping patients and meeting all sorts of people, and conducting dental research. Also her participation in the alcohol and suicide prevention project aimed researchers to look at whether the association between alcohol consumption and suicide rates varied throughout different drinking cultures.

Abstract: In the wake of the deteriorating situation of drug addiction and related infectious diseases among injecting drug users (IDUs) in China in recent years, the Standing Committee of the National People''s Congress of China adopted the new Drug Control Law which came into force in June 1, 2008. This law is part of a broad reform movement in China where drug addiction is no longer understood as simply a legal or moral issue but rather, as a complicated medical condition requiring comprehensive therapeutic strategies. Although the Drug Control Law draws a distinct line from previous Drug Control regulations in the country, there have still been dilemmas along the implementation process. This paper is intended to elaborate on the general principles of China''s latest Drug Control Law from the point of view of scholars who are involved in the field of drug addiction research and treatment in China. This paper will also discuss the challenges we are currently facing, based on the observations and practical experiences the authors have obtained in China. It is hoped that by addressing these issues, we will be able to implement the new Drug Control Law more successfully and ensure that we deal more effectively with drug addiction in China. [Copyright &y& Elsevier]

The US Food and Drug Administration (FDA) Amendments Act was signed into law in 2007. It grants several additional authorities to the FDA, including requiring manufacturers in some situations to implement risk evaluation and mitigation strategies (REMS). There are currently over 100 approved REMS listed on the FDA website. In the vast majority of REMS, only a medication guide, or this and a communication plan, is required. A review of the published literature suggests that the traditional paper-based communication tools developed and used over the decades by the FDA and drug industry, such as medication guides and dear doctor letters, have not been shown to be effective or durable in changing prescriber or patient behaviours leading to risk reduction. Despite this, they currently serve as the primary tools used for risk mitigation. Paper-based communication tools need to be critically evaluated for future use and replaced with more effective risk communication strategies. Evaluation methods for new REMS communication tools also need to be validated. [ABSTRACT FROM AUTHOR]

In this paper, we will discuss California's recent experiment with medical marijuana. To that end, we will first discuss the history of marijuana use. Next we will discuss the history and current trend in federal marijuana regulation. We will then examine California's medical marijuana law. We will conclude with three lessons for other states from California's attempt to regulate medical marijuana. The three practical lessons are: limit the eligible conditions; limit the number of dispensaries; and tax the marijuana. [ABSTRACT FROM AUTHOR]

This paper seeks to highlight Mexico's interest in being at the forefront in Latin America and at the same time at the international level with the major players in the field of biotech medicines. Mexico has just adopted an amendment to the General Health Law that would allow the regulatory approval of biocomparable drugs (some countries refer to these as biosimilar or biogeneric drugs). Such reform consists in the incorporation of Article 222 Bis, which describes what is regarded as a biotechnology medicine, distinguishes between innovative and biocomparable medicines, sets the requirements to obtain sanitary registration and for marketing, describes the regulations regarding the pharmacovigilance of these products, as well as the studies that are necessary to demonstrate the quality, safety and efficacy of a biocomparable medicine which is supported with reference to an innovative medicine, and taking into consideration the Opinion of the Committee of New Molecules through the Subcommittee for the Evaluation of Biotechnology Products. This amendment also includes the assignment of the same International Non-propriety Name (INN) as for the reference product. The goal of the reform is to encourage competitiveness in Mexico by regulating the manufacture and approval of these medicines making them more affordable and hence fostering their access to the population. [ABSTRACT FROM AUTHOR]

Aims:This paper examines the epidemiology of ecstasy use and harm in Australia using multiple data sources. Design: The data included (1) Australian Customs Service 3,4-methylenedioxymethamphetamine (MDMA) detections; (2) the National Drug Strategy Household and Australian Secondary Student Alcohol and Drug Surveys; (3) data from Australia’s ecstasy and Related Drugs Reporting System; (4) the number of recorded police incidents for ecstasy possession and distribution collated by the N.S.W. Bureau of Crime Statistics and Research; (5) the number of calls to the Alcohol and Drug Information Service and Family Drug Support relating to ecstasy; (6) the Alcohol and Other Drug Treatment Services National Minimum Dataset on number of treatment episodes for ecstasy, and (7) N.S.W. Division of Analytical Laboratories toxicology data on number of deaths where MDMA was detected. Findings: Recent ecstasy use among adults in the general population has increased, whereas among secondary students it has remained low and stable. The patterns of ecstasy consumption among regular ecstasy users have changed over time. Polydrug use and use for extended periods of time (>48 h) remain common among this group. Frequent ecstasy use is associated with a range of risk behaviours and other problems, which tend to be attributed to a number of drugs along with ecstasy. Few ecstasy users present for treatment for problems related to their ecstasy consumption. Conclusions: Messages and interventions to reduce the risks associated with polydrug use and patterns of extended periods of use are clearly warranted. These messages should be delivered outside of traditional health care settings, as few of these users are engaged with such services. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Abstract: Background: The introduction of political “war on drug” strategies and Prime Ministerial advisory groups increase opportunities for drug policy reform. Yet the strengths and limitations of capitalising upon political opportunities remain unclear. This paper provides a unique insight into the development of an Australian reform, the “Tough on Drugs-Illicit Drug Diversion Initiative.” This reform was one of the major policies to emerge out of the Federal Coalition “Tough on Drugs” strategy. In spite of the rhetoric the Illicit Drug Diversion Initiative (IDDI) has diverted minor drug users away from the traditional criminal justice system. Methods: This paper draws upon interviews with 16 expert policy makers involved in the advocacy and negotiations leading up to the adoption of the IDDI to examine what drove the reform and how and why a pragmatic reform emerged. Results: The IDDI culminated from the presence of five main drivers: a crisis in relation to heroin and crime, antagonism towards the government, a weak but growing evidence-base on the merits of drug diversion, a shift in law enforcement attitudes and persuasive advocacy by a group of non-government experts. This paper contends that the Prime Minister''s new “Tough on Drugs” strategy and expanded governance arrangements created new space for policy actors to intervene in the policy formulation process and to convert the governments proposed “zero tolerance” response into a more humane and potentially effective response. Conclusion: This paper concludes that contrary to popular opinion political venues and politicisation may offer valuable opportunities for drug policy reform. The challenge for researchers and policy advocates is to see how they can best utilise political venues to obtain pragmatic reform. [Copyright &y& Elsevier]

The drug treatment court as a response to addiction, and restorative justice as a theoretical paradigm, have both emerged as significant influences upon criminal justice and societal and governmental responses to criminal behavior. The drug treatment court includes elements and features of restorative justice. The concept of restorative justice, with its focus on the reintegration of offenders, victims, and community, may be considered a theoretical construct within which to examine, evaluate, and further develop the drug treatment court model of addressing the problem of drug addiction. This examination also raises the question: what is restorative justice? This paper considers the restorative features of drug treatment courts, the limits of restorative justice, and ways in which the drug treatment court may benefit from restorative justice. [ABSTRACT FROM AUTHOR]

Prior marketing literature has overlooked the role of regulatory regimes in explaining international sales growth of new products. This paper addresses this gap in the context of new pharmaceuticals (15 new molecules in 34 countries) and sheds light on the effects of regulatory regimes on new drug sales across the globe. Based on a time-varying coefficient model, we find that differences in regulation substantially contribute to cross-country variation in sales. One of the regulatory constraints investigated, i.e., manufacturer price controls, has a positive effect on drug sales. The other forms of regulation such as restrictions of physician prescription budgets and the prohibition of direct-to-consumer advertising (DTCA) tend to hurt sales. The effect of manufacturer price controls is similar for newly launched and mature drugs. By contrast, regulations on physician prescription budgets and DTCA have a differential effect for newly launched and mature drugs. Whereas the former hurts mature drugs more, the latter has a larger effect on newly launched drugs. In addition to these regulatory effects, we find that national culture, economic wealth, and lagged sales also affect drug sales. Our findings may be used as input by managers for international launch and marketing decisions. They may also be used by public policy administrators to assess the role of regulatory regimes in pharmaceutical sales growth. [ABSTRACT FROM AUTHOR]

The Licensing Act 2003 (covering England and Wales) introduced greater flexibility to the UK licensing laws, including the possibility of 24-h licenses. This paper reports a nation wide survey of 225 (63%) local authority chairs of licensing committees/senior members of licensing teams in England evaluating the short-term impact of the Act. A cumulative impact (saturation) area was only declared in 38 (17%) local authorities. Extended hours applications were more common than new applications in both on- and off-licensed premises. The perception of those surveyed was of 'no change' in the following alcohol-related variables; public noise levels (n = 133, 59%) violence and fights (n = 130, 60%), under-aged drinking (n = 143, 67%), crime (n = 141, 68%), and drink-driving (n = 157, 86%). Contrary to the picture often presented in certain parts of the mass-media, the impact of the Licensing Act appears to be neutral. However, these are likely to be the result of a number of intervening factors, rather than the change to a more liberalized licensing regime. The role of the police would seem to be fundamental. Future research will need to disentangle the impact of these intervening factors and it will be a number of years before the impact of these changes can be assessed. [ABSTRACT FROM AUTHOR]

Reports on the introduction of a draft policy paper on the distribution of medicines in Great Britain. Emphasis on animal health and welfare and of public safety; Proposal of the maintenance of a three-tier system of medicines; Policy governing the training and monitoring standards of veterinary prescriptions.

The article presents an update on criminal law legislation in Great Britain as of December 2010. The Misuse of Drugs Act 1971 Order 2010 which took effect last July 23, 2010 specifies a group of cathinone derivatives as subject to control as Class B drugs under that Act. Responses to a Consultation Paper on Criminal Liability in Regulatory Contexts issued by the Law Commission on August 25, 2010 will be accepted until November 25.

Introduction and Aims. A large legal market for party pills containing benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) developed in New Zealand after 2004. The use of these party pills has been associated with adverse health effects. The purpose of this paper was to assess a general population sample of party pill users to investigate the relationship between (1) patterns of use of BZP/TFMPP party pills and concurrent use of other drug types, and (2) adverse side effects from BZP/TFMPP party pill use. Design. A national household survey of the use of BZP/TFMPP party pills was conducted using a computer-assisted telephone interviewing (CATI) facility. The quantity of BZP and TFMPP in each brand of party pill was obtained from the National Poisons Centre. Multiple logistic regression analysis was used to identify independent predictors of having experienced adverse side effects from party pills. Results. The mean quantity of BZP/TFMPP taken on an occasion of greatest use was 533 mg (median 400 mg, range 43 - 2500 mg). Being female, using cannabis and other drugs concurrently with BZP/TFMPP party pills, taking large quantities of party pills in a single session and taking 5-hydroxytryptophan (5-HTP) recovery pills at the same time as party pills were independent predictors of having experienced an adverse problem from party pills. Conclusions. Females may be at greater risk of experiencing problems from BZP/TFMPP party pills due to their smaller physical size. Taking 5-HTP 'recovery' pills with party pills may increase the risk of adverse effects as both substances increase users' levels of serotonin. [ABSTRACT FROM AUTHOR]

Abstract: In 1988, sociologist Stephen Mugford argued that the dominant framework in the drugs field was the ‘pathology paradigm’ and that, as a consequence, considerations of ‘pleasure’ in relation to drug use were marginalised. As Mugford noted, an understanding of the subjective motives for drug use, including pleasure, is an essential part of any coherent response. Twenty years on, it appears that little has changed. In this paper, I consider some of the processes that may have contributed to the ongoing absence of discourses of pleasure in the drugs field. The paper is divided into three sections. In the first, following Bourdieu, I focus on drug research as a ‘social field’, arguing that power relations between research disciplines work against considerations of pleasure, and that researching pleasure does not generate useful forms of research capital. Second, I argue that harm reduction policy and practice, in its construction of a neo-liberal drug-using subject, limits opportunities for considering the role of pleasure in drug use. The final section explores the broader historical and contemporary context for drug research, policy and practice by considering the discursive formations that contribute to the legitimacy granted to particular forms of pleasure in the privileging of a ‘civilised’ body over a ‘grotesque’ body. [Copyright &y& Elsevier]

We present findings from a qualitative study of 80 women and men who sold Ecstasy in private settings. In this paper we explore Ecstasy sellers' identity processes and pathways to dealing. Interviewees believed "real dealers" sold in public settings to people they did not know and relied on drug sales as their main source of income. We found that 76% of the sample resisted the dealer identity due to the stigma associated with dealing, Ecstasy's benign reputation, selling in private settings, and customer bases that comprised mainly friends. The majority of the sample "drifted" into dealing and did not consciously decide to sell. Additionally, most interviewees did not implement precautionary sales strategies that characterize drug dealing operations described in our own and other investigators' research on drug markets. Ecstasy sellers created new, more positive identity constructions for themselves, which is also an important focus of this paper. [ABSTRACT FROM AUTHOR]

Background Δ9-Tetrahydrocannabinol (THC) is the major psychoactive constituent of cannabis and its various preparations. Increasing use of cannabis for recreational purposes has created a problem for road-traffic safety. This paper compares age, gender and the concentrations of THC in blood of individuals apprehended for driving under the influence of drugs (DUID) in Sweden, where a zero-tolerance law operates. Measurements Specimens of blood or urine were subjected to a broad screening analysis by enzyme immunoassay methods. THC positives were verified by analysis of blood by gas chromatography-mass spectrometry (GC-MS) with a deuterium-labelled internal standard (d3-THC). All toxicology results were entered into a database (TOXBASE) along with the age and gender of apprehended drivers. Findings Over a 10-year period (1995–2004), between 18% and 30% of all DUID suspects had measurable amounts of THC in their blood (> 0.3 ng/ml) either alone or together with other drugs. The mean age [± standard deviation (SD)] of cannabis users was 33 ± 9.4 years (range 15–66 years), with a strong predominance of men (94%, P < 0.001). The frequency distribution of THC concentrations ( n = 8794) was skewed markedly to the right with mean, median and highest values of 2.1 ng/ml, 1.0 ng/ml and 67 ng/ml, respectively. The THC concentration was less than 1.0 ng/ml in 43% of cases and below 2.0 ng/ml in 61% of cases. The age of offenders was not correlated with the concentration of THC in blood ( r = −0.027, P > 0.05). THC concentrations in blood were higher when this was the only psychoactive substance present ( n = 1276); mean 3.6 ng/ml, median 2.0 ng/ml compared with multi-drug users; mean 1.8 ng/ml, median 1.0 ng/ml ( P < 0.001). In cases with THC as the only drug present the concentration was less than 1.0 ng/ml in 26% and below 2.0 ng/ml in 41% of cases. The high prevalence of men, the average age and the concentrations of THC in blood were similar in users of illicit drugs (non-traffic cases). Conclusions The concentration of THC in blood at the time of driving is probably a great deal higher than at the time of sampling (30–90 minutes later). The notion of enacting science-based concentration limits of THC in blood (e.g. 3–5 ng/ml), as discussed in some quarters, would result in many individuals evading prosecution. Zero-tolerance or limit of quantitation laws are a much more pragmatic way to enforce DUID legislation. [ABSTRACT FROM AUTHOR]

Illicit drug policy interventions cover treatment, law enforcement, prevention and harm reduction. This paper provides a comprehensive list across these sectors, of known drug policy interventions. One hundred and eight interventions were identified. With such a long and undifferentiated list of drug policy interventions, the ways in which these interventions are then coded and classified is also addressed. Ten different classification schemes are reviewed including summary information on the original sources and backgrounds to the schemes. The authors rated each of the policy interventions against the schemes. Those which proved useful in summarising illicit drug policy interventions included the four pillars approach, the UNODC classification, the demand, supply and harm reduction paradigm, the public health model and the policy instruments model. The list of 108 policy interventions will be of use to policy makers, researchers and practitioners in appreciating the array of drug policy options, and could be used in reviews of policy or practice. The classification schemes reveal the different ways in which drug policy interventions can be clustered and described to different audiences. [ABSTRACT FROM AUTHOR]

In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products; cosmetics; radiation-emitting electronic products; veterinary products; and all foods, except meat and poultry (which are regulated by the Department of Agriculture). According to the FDA, the products it regulates account for more than one-fifth of U.S. consumer spending. In the area of medical products, the FDA is responsible for determining whether marketed products are both safe and effective before and after they have been marketed. In this paper, we will explore whether the policies of the agency itself are safe and effective. We stress two issues, one static and one dynamic. The static issue concerns the potential duplication inefficiency when product safety is protected not only by the FDA but also by the private sector through product liability law. Put another way, what is the rationale for using product liability and the FDA to regulate drug safety? While intuitively it may seem that two systems must be better than one in ensuring drug safety, each system comes with costs. We then turn to the dynamic issue, the speedsafety trade off, and consider the extent to which higher safety is achieved at a cost of later market entry of effective and even life-saving products. We assess the Prescription Drug User Fee Acts (PDUFAs), which increased the speed of the agency's regulatory process starting in 1992, although according to some, at the cost of reducing drug safety. We conclude by suggesting a research agenda for future work on the Food and Drug Administration. [ABSTRACT FROM AUTHOR]

Drug policy within the UK has been challenged to a greater degree in the last twelve months than at any time over the last ten years. That challenge consists of reports from the Royal Society of Arts and the UK Drug Policy Commission as well as empirical research on the classification of drugs within the Misuse of Drugs Act. These documents identify major weaknesses in the content, direction and delivery of UK drug policy and propose a new direction of policy and new elements of drug policy. In the case of the RSA report and the report from the UK Drug Policy Commission the principal recommendation is for drug policy to shift from its current tri-partite focus on treatment, prevention and education to focus first and foremost on reducing drug-related harm. This paper critically considers the assessment of drug policy set out within these reports and looks at the possible impact of a drug policy that prioritized harm reduction over prevention and enforcement. [ABSTRACT FROM AUTHOR]

Previous empirical studies that have examined the links between pharmaceutical price controls, profits, cash flows, and investment in research and development (R&D) have been largely based on retrospective statistical analyses of firm- and/or industry-level data. These studies, which have contributed numerous insights and findings to the literature, relied upon ad hoc reduced-form model specifications. In the current paper we take a very different approach: a prospective micro-simulation approach. Using Monte Carlo techniques we model how future price controls in the US will impact early-stage product development decisions in the pharmaceutical industry. This is done within the context of a net present value (NPV) framework that appropriately reflects the uncertainty associated with R&D project technical success, development costs, and future revenues. Using partial-information estimators calibrated with the most contemporary clinical and economic data available, we demonstrate how pharmaceutical price controls will significantly diminish the incentives to undertake early-stage R&D investment. For example, we estimate that cutting prices by 40–50% in the US will lead to between 30 and 60% fewer R&D projects being undertaken (in early-stage development). Given the recent legislative efforts to control prescription drug prices in the US and the likelihood that price controls will prevail as a result, it is important to better understand the firm response to such a regulatory change. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Despite the rapid expansion of options to coerce drug-dependent offenders into treatment—culminating recently in the provisions of the 2005 Drugs Act and the government's 'Tough Choices' agenda—research findings to date are equivocal about their impact in reducing crime. This paper presents UK findings from a pan-European study on this issue. The results—at both national and international levels—reveal that court-mandated clients reported significant and sustained reductions in illicit drug use and offending behaviours, and improvements in other areas of social functioning. Those entering the same treatment services through non-criminal justice routes also reported similar reductions and improvements. The implications of these findings are discussed in the context of recent policy developments. [ABSTRACT FROM AUTHOR]

Drug misuse is associated with a wide range of potential consequences for individual drug users, their families, communities and the rest of society. Debates about drug policy choices are influenced more by opinion and implicit values than scientific evidence. This paper argues that economic evaluation techniques provide a valuable framework to explore the different impacts of drug policy choices. [ABSTRACT FROM AUTHOR]

Many civil society organisations (CSOs) have been at the forefront of identifying new ideas and implementing innovative models regarding health and health systems around the world. Their activities become highly charged, however, when they engage in advocacy efforts designed to influence change in policies and systems linked with more controversial or complicated public health issues. Policies, laws and regulations regarding illicit drugs and tobacco fall directly into that category. There is no doubt that the use of both kinds of substances can have the same health consequences—including ill health and death—yet they are approached in widely different ways. Smoking is legal to some extent in every country in the world, and is generally considered a matter of personal choice. Many people believe that efforts to limit tobacco use are coercive and impede on individual rights. Those who use illicit drugs such as heroin, meanwhile, are with few exceptions considered social deviants, misfits and lawbreakers. Many CSOs support comprehensive, government-funded prevention strategies coupled with non-punitive, non-judgemental programmes designed to help users change behaviour. Such strategies are designed to reflect and respond to the medically addictive nature of both tobacco and many illegal drugs. Proponents argue that not only are the public health benefits of expansive, well-conceived interventions potentially vast, but so too are the social and economic benefits accruing from lower rates of debilitating disease and premature death. To that end, many international, national and local CSOs are identifying the direct and indirect health consequences of tobacco and illegal drug use; proposing and advocating for strategies to limit their impact; and sharing information and resources with like-minded organisations elsewhere. This leadership role has helped influence and shape policy, especially in recent years. This paper examines civil society's involvement in efforts to change drug and tobacco policy in selected countries in Central and Eastern Europe and the former Soviet Union (CEE/FSU). It concludes that in Poland and Kazakhstan, in terms of tobacco control, and increasingly in Ukraine and parts of Central Asia in terms of harm reduction, multi-sectoral approaches are the most effective way to engage citizens and to implement comprehensive strategies to change behaviour by supportive measures, not punitive ones. [Malinowska-Sempruch K, Bonnell R, Hoover J. Civil society—a leader in HIV prevention and tobacco control. Drug Alcohol Rev 2006;25:625 – 632] [ABSTRACT FROM AUTHOR]

Many security‐related roles that were customarily the responsibility of governments and public police agencies have become commercialized, devolved, or otherwise dispersed. This phenomenon has been described as ‘multilateralization.’ The paper sets out to analyse the multilateralization of policing as it applies to strategies of supply reduction in the area of illicit synthetic drugs, focusing in particular upon amphetamine type substances. Supply reduction can constitute interventions not ordinarily thought of as drug law enforcement and entail a range of technologies underpinned by regulatory theory. Various strategies of engaging external institutions in furtherance of reducing the supply of illicit synthetic drugs are canvassed. The authors provide an analytical framework for understanding how illicit synthetic drugs can be governed through strategies of co‐production and the possible barriers and issues that need to be considered when attempting to engage the crime control capacities of external institutions. [ABSTRACT FROM AUTHOR]

This paper examines generic competition following the enactment of the 1984 Waxman-Hatch Act. Unlike the existing literature, we employ antibiotics as a control group to infer legislation-induced increases in generic competition. Using FDA drug approval data, we find evidence that the Act enhanced generic Competition, resulting in 1.5 times more competition between nonantibiotic drugs than between antibiotics. Moreover, the Act's overall impact is greater for newer drugs than older drugs. [ABSTRACT FROM AUTHOR]

Purpose - To determine whether direct-to-consumer prescription drug advertising influences consumers' behavioral intentions. Design/methodology/approach - Gathered data from 288 respondents using a pencil and paper mail survey. Respondents were asked about their knowledge and behavior regarding prescription drugs. Findings - indicated that while consumers generally have favorable perceptions of prescription drug advertising, their behavioral intentions are nevertheless influenced by a heightened awareness of specific branded drugs. Consumers feel empowered by the information provided in direct-to-consumer advertising and they are concerned about governmental attempts to regulate prescription drug advertising. Research limitations/implications - Data was collected from a relatively homogenous sample with respect to ethnicity. Future research efforts could include respondents from diverse ethnic backgrounds and could incorporate questions regarding respondents' actual behaviors with respect to branded prescription drug medications. Practical implications - Useful information for researchers, public policy makers and prescription drug manufacturers. Results suggest that consumer motivation to request branded drugs may be impacted by factors related to the quality of advertisements, trust in their physician, and personal competence. Consumer interest in advertised drugs may also depend on the strength of the relationship that they have with their physician. Originality/value - This research fills an identified gap in the literature. While researchers have examined consumers' general perceptions of direct-to-consumer prescription drug advertising, little research has been done on the link between consumer perceptions and behavioral intentions. [ABSTRACT FROM AUTHOR]

Features the issues discussed at the eighth annual Frontiers in Health Policy Research meeting held in Washington, D.C. in June 2004. Approval process for pharmaceuticals; Provisions of the Prescription Drug User Fee Act of 1992; Interest of workers in health insurance.

Describes a regulatory approach with detailed guidance on specific sections of the European Clinical Trials Directive for filing Chemistry, Manufacturing, and Controls (CMC) information concerning the drug substance in Phases 1, 2, and 3. Aspects of the Directive which was first proposed as a White Paper in 1991 and published as a draft directive in 1997 in the European Union; Critical drug substance information necessary to support the investigational medicinal product dossier (IMPD) in each clinical study phase; Approach that supports the filing requirements for investigational new drug applications (IND) in the U.S. Department of Health and Human Services.

In this paper Moore & Dietze use data from their study of street-based injecting drug users and sex workers in the Melbourne suburb of St Kilda to challenge the dominant emphasis of drug policy in Australia. They remind us that while existing harm reduction strategies that encourage individual behaviour change should be continued, these measures need to be complemented and extended by further attention to the environmental aspects of drug-related harm. This is a timely call. Responses targeting individual behaviour change are relatively easy to implement and less politically challenging. However, if we are really serious about reducing drug-related harm in the Australian community, then broader systemic and structural barriers which undermine these efforts must be addressed.Simon LentonEditor, Harm Reduction Digest. [ABSTRACT FROM AUTHOR]

British drugs legislation has recently been changed to reclassify cannabis from a Class B drug to a Class C one. The reclassification is intended to reflect more accurately the risks posed by cannabis relative to other drugs. The debate about reform of the British laws in regulating cannabis possession has tended to ignore the fact that even before cannabis was reclassified as a Class C drug, police officers often turned a 'blind eye' to cannabis offences, or else gave informal warnings. This paper examines the political background to reclassification. It then examines the factors that guide officers to use their discretion and informally dispose of cannabis offences. It goes on to consider the impact that reclassification may have on informal action. The data are drawn from a detailed study of the policing of cannabis prior to reclassification, conducted by the Institute for Criminal Policy Research. We demonstrate that a multiplicity of police, offender and situational factors, either alone or in combination, influence an officer's decision to take informal action on the street. We outline the potential for reclassification to generate a reduction in the use of informal disposals, which may create a `net-widening' effect, or an increase in use, which might lead to the offence being selectively decriminalized. The implications for both scenarios are considered. [ABSTRACT FROM AUTHOR]

1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implementing the Directive nationally at the same time and all being affected by the many and varied aspects covered in the Directive. The paper looks at the new changes to European clinical trials and what this will mean for the pharmaceutical industry and research academia alike, especially in relation to safety reporting and risk/benefit assessments. [ABSTRACT FROM AUTHOR]

A global revision of the European regulatory framework for medicinal products, the 'Pharma Review', has recently been adopted by the European Institutions. This is an important step for the competitiveness of the European life sciences industry, as this 'Pharma Review' has numerous and significant implications for companies involved in the field of biotechnology. Three main amendments can be highlighted in this context: (1) the strengthening of the European Agency for the Evaluation of Medicinal Products (EMEA) as a scientific advisory body, which will enable biotechnology firms to get high-quality scientific advice early in the drug development process; (2) new marketing authorisation procedures, which will provide a simpler and faster market access for 'breakthrough' medicinal products when no therapeutic alternative is available; and (3) the establishment of an EU-harmonised data protection scheme, in order to set the appropriate balance between innovation and the development of the generics industry. The objective of this paper is to explore these essential regulatory changes, which all aim at meeting one critical challenge: enabling innovative firms to get streamlined access to the enlarged European market without compromising public health. [ABSTRACT FROM AUTHOR]

This paper examines the day-to-day implementation of drug legislation in the United Kingdom (UK) by enforcement agencies, prosecution authorities, and courts within the broader contexts of national law on drug trafficking and possession, international drug conventions (especially the 1988 United Nations Convention), and issues concerning security and transnational organized crime. The situation in the UK is described, with some European comparison points. Increasingly, both in terms of the letter of the law and in everyday practice, police action against drug users in relation to simple possession is being deemphasized, especially with regard to cannabis. Government prioritizes its anti-trafficking action, especially in relation to "the drugs that do most harm. "The ways in which this strategy fits with the international drug conventions is outlined. In conclusion, this paper speculates how, in the light of the current climate surrounding international security, UK and other European drug policies might develop in future. [ABSTRACT FROM AUTHOR]

This paper begins with a brief overview Czech drug policy and drug-related issues. The second section concentrates on how that policy has evolved since the fall of communism, identifies the main players in these events, and provides some details about the legislative procedure that eventually led to the reintroduction of punishments for the possession of illegal drugs. The paper describes in broad terms a major scientific evaluation of the impacts of recent legislative changes and subsequent government reactions to that report. Recent developments in the Czech drug policy debate are addressed in the third section of the paper. This account focuses on the ongoing legislative debate over whether the possession of drugs for personal use should be a criminal offense (this issue has been contested for nearly 10 years). Finally, a controversial legislative proposal that was only recently issued by the Ministry of Justice will be described. [ABSTRACT FROM AUTHOR]

The teaching of pharmacoepidemiology has been largely confined to health care professionals and graduate students. This paper reports an attempt to use problem-based learning (PBL) to teach the elements of that discipline to undergraduate science students. Carefully sequenced problems led students to consider the following issues: the terms used in epidemiology, merits and demerits of different epidemiological study designs, pharmacovigilance, the nature of evidence in law and science, economic evaluation of drugs and the use of drugs in different cultures. The 12-week course was taken by students in their final term prior to graduation. Multiple evaluation procedures were used: specific forms for assessing tutorial participation, individual explorations assessed usually by written essays and problem-solving exercises. The course has received high ratings from the students. The observations over a 10-year period suggest that PBL is a feasible approach to teach the social dimensions of drug use. [ABSTRACT FROM AUTHOR]

Compared with the quantity and quality of information available for adults, the data guiding the dosing, efficacy and safety of medications for children have lagged substantially. This is ironic, because tragedies that primarily involved children spurred the passage of the major pieces of legislation that govern the development of drug products. Clinicians faced with the prospect of confining their practice to medications with adequate information have frequently resorted to prescribing drugs for unapproved uses (different dose, frequency, age group, route, indication or formulation). Although a long time in coming, the past six years, particularly in the United States, have witnessed a new era in drug development for children - an era that is still in its infancy, but which is now showing signs of maturation. This paper will review some of the history and current progress in paediatric drug development, with an emphasis on the developments in the United States, and will examine some of the current controversies and prospects for future progress. [ABSTRACT FROM AUTHOR]

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Since 1989 drug situation in Poland has changed considerably. First, Poland has become a major European producer of synthetic drugs. Second, it has become a major transit country for smuggling drugs. Third, while its drug markets are not yet fully developed, they offer now a much broader selection of drugs than the pre-1989 staple drug, the home-made "Polish heroin". Despite some alarm about a growing drug problem, Polish drug policies remained for many years primarily public health oriented. The recent drug law reforms may signify, however, a shift towards a more punitive approach. This paper explores the conditions surrounding the emergence of both new markets and new control strategies. [ABSTRACT FROM AUTHOR]

Risk assessment as a regulatory tool developed during virtually all of the 20th century. During this period there were several critical events such as the passage of the Food and Drug Acts of 1906 and 1938 and the publication of the National Research Council's report Risk Assessment in the Federal Government: Managing the Process, known as the "Red Book," which defined the concepts and principles of risk assessment. This paper reviews the impact of some of the major events in the evolution of risk assessment and concludes with some speculation on the future. Key Words: FDA Laws; Red Book; risk; National Research Council; safety; thresholds. [ABSTRACT FROM AUTHOR]

This paper examines the course of drug control within the European Union (EU). The individual policies of both the liberal Netherlands and the more repressive Sweden are explained in detail, and the effects they have on the EU as a whole are discussed. In order to understand these effects more fully an inspection of recent drug legislation developed in the fight against drugs is undertaken. Current trends relating to the drug problem that can be identified throughout the member states are presented and evaluated with respect to the policies of both the Netherlands and Sweden. A division within the EU centering around the different policy styles of these two nations is discussed and possible solutions to the division are raised. Finally, the positive effects that this battle has resulted in are noted. [ABSTRACT FROM AUTHOR]

Drug development and regulation are often presented as purely matters of technical science. In this paper it is argued that, in principle, toxicology, clinical pharmacology and pharmacovigilance in drug testing and regulation are necessarily a combination of science and politics. This has important implications for how one attempts to make progress in drug regulation, such as in interpreting technical evidence and in the setting of regulatory standards with which evidence should be evaluated. In practice, drug testing and regulation are shown to be hybrids of science and politics. Moreover, drawing on existing empirical evidence, it is suggested that this mixture currently, and for some time, has had the wrong ingredients for optimal drug safety and public health outcomes. For example, too often the balance of the scientific doubts about drug safety are weighed to the interests of manufacturers rather than to those of patients and public health, while some scientific standards with which drug safety is to be interpreted are being reshaped in ways that give insufficient priority to the protection of public health. Finally, it is proposed that: drug regulation should include comparative efficacy testing; regulatory agencies should conduct some key tests, charging the costs to industry and without duplication; and the regulatory system should be less secretive and more accountable to public scrutiny. Greater efforts should be made to eliminate experts' conflicts of interest within the regulatory process. [ABSTRACT FROM AUTHOR]

This paper introduces the term reclamation activism to refer to the processes by which social movements make claims based upon a real or imagined status quo ante during a period of transition. The motivation for a reclamation stance is the perception that a social good—such as some combination of social, economic or political privileges or cultural dominance—is being threatened. The notion is applied to the analysis of a modern social movement, the parents' movement against drug use in the USA. Based upon content analysis of movement literature, the claim is made that the movement is organized in opposition to its image of a 'pro-drug culture' rather than actual patterns of drug use. This oppositional stance is shown to have advantages for the movement over other claims-making strategies. [ABSTRACT FROM AUTHOR]