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Focuses on the effect of governmental control on drug safety and the process of drug regulation in the United States. Role of Food and Drug Administrations on the introduction of drugs; Background of drug regulation; Impact of the legislation on the drug industries.

In both the United Kingdom and United States of America legislation has been proposed or enacted which claims to provide patients with a 'right' of access to experimental drugs and treatments where there is no other hope. In this paper we will explore this narrative and consider the steps taken in the United States to shift to a more rights driven legal framework. The paper will critically assess the United States model and the similarly framed 'Saatchi' model in the United Kingdom; demonstrating that, despite the rights-based narrative, these laws do not represent a significant change in access to treatment for patients. Rather, the reality is that this 'right to try' paradigm represents a patient advocate narrative that is deeply flawed. It fails to implement any meaningful change, exposes vulnerable patients to risk of harm and, potentially, delays safe development of potentially life-saving treatment regimes. [ABSTRACT FROM AUTHOR]

Under the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, individuals convicted of drug-related felonies were permanently banned from receiving welfare and food stamps. Since then, over 30 states have opted out of the federal ban. In this paper, I estimate the impact of public assistance eligibility on recidivism by exploiting both the adoption of the federal ban and subsequent passage of state laws that lifted the ban. Using administrative prison records on five million offenders and a triple-differences research design, I find that public assistance eligibility for drug offenders reduces one-year recidivism rates by 10 percent. [ABSTRACT FROM AUTHOR]

While state drug law reform is moving apace, federal drug law reform has moved much more slowly. Many, including the Judicial Conference of the United States and the United States Sentencing Commission, have urged Congress to enact substantive federal drug law reform for years. But Congress has not acted. As a result, the federal system continues to single out drug offenses for harsh treatment at the bail stage and the sentencing stage--the front end and back end of the federal mass incarceration crisis. In this paper, we argue that federal judges have a critical role to play in future federal drug law reform in light of Congress' long-standing failures to meaningfully change the laws. At the front end, judges should encourage the release of more people on bail by closely scrutinizing prosecutors' motions for temporary detention and giving little weight to the Bail Reform Act's presumption of detention. Data shows that the statutory drug presumption is overbroad and does a poor job of determining who is a risk of flight or a danger to the community. At the back end, judges should issue categorical policy disagreements with the drug sentencing guidelines and the career offender sentencing guideline using the Supreme Court's blueprint in Kimbrough v. United States. Judges should issue sentences below these guidelines because they are not based on empirical evidence, over-punish drug offenses, and result in racial disparities. At both ends, judges should rest their decisions on the evidence that the drug presumption, the drug sentencing guidelines, and the career offender sentencing guideline are flawed. While judicial action is not a cure for Congressional inaction, it would send a clear message from one co-equal branch of government to another that substantive reform is urgently needed. [ABSTRACT FROM AUTHOR]

This paper explores events surrounding the US Food and Drug Administration's formal approval of the heart failure drug BiDil in 2005. BiDil is the first drug ever to be approved with a race-specific indication, in this case to treat heart failure in 'self-identified black patients'. BiDil has been cast by many as a step toward the promised land of individualized pharmacogenomic therapies. This paper argues, however, that when examined in context, the approval of BiDil emerges as a new model of how a pharmaceutical company may exploit race in the marketplace by literally capitalizing on the racial identity of minority populations and leveraging the disproportionate risk of adverse health outcomes they suffer into a cheaper, more efficient way to gain the US Food and Drug Administration's approval for drugs. Discussions of BiDil in both popular media and professional journals have repeatedly elided the difference between pharmacogenomic and race-based medicine. In fact, broad-based true pharmacogenomic therapies remain years—perhaps decades—in the future. The story of BiDil's development elucidates an alternative model to developing tailored therapies that promises to fill in the gap between the promise and reality of pharmacogenomic medicine. It is a model that exploits race to gain regulatory and commercial advantage, while ignoring its power to promote a regeneticization of racial categories in society at large. [ABSTRACT FROM AUTHOR]

In an era which marks an exceptional phase of growth in science and technology, the acute disparities in access to healthcare still persist. So where on one hand scientific advancement in medicine aims at increasing life expectancy, on the other hand there are millions who are denied access to existing medicines. Patents on medicines also pose a significant barrier to access new drugs, especially in low and middle income countries which already suffer from poor health financing mechanisms. The patent laws were built on the assumption of incentivizing the innovators by rewarding them with the exclusive right to produce, sell or market the innovation. The basic premise for granting patents was based on the thought that it would increase investment in research and development promoting dynamic gains through newer innovations. However, evidence found to support this justification is meager. So in a situation where the drug gap still persists and we aim to achieve sustainable development goals by 2030, this paper attempts to focus on understanding how compulsory licensing has been used in selected cases to alleviate the major legal and political barriers to access medicines. The methodology comprises of cross-country comparison of patent framework and compulsory licensing cases. The sample selected for study includes both developed as well as developing countries. The aim is to evaluate the policy approaches used by selected countries to grant compulsory licenses and to identify the best practices for evidence-based policy making on international issues related to pharmaceutical patents. In each case, a driving factor has been the international extension of patent laws through trade agreements; first bilaterally (US-Canada) and subsequently internationally (1995 Uruguay round, under which low- and middle-income countries were granted a grace period until 2005 to comply). [ABSTRACT FROM AUTHOR]

In 2004, Europe took the lead among regulated markets in creating a legal framework and a regulatory route for biogenerics. The EU has consequently established a competitive advantage over the USA and Japan in this sector. This paper covers the process of drafting and adopting the legal framework for biogenerics in the enlarged EU through the review process of the European pharmaceutical legislation and in parallel with the publication of the new Annex I of Directive 2001/83/EC, which delineates instructions for the presentation and content of the different types of application dossier in Europe. This paper describes the precise chronological order of the development of the legal framework, as well as the main actors in the process, and describes the background to the adoption of the final terminology used to designate biogenerics - that is, 'similar biological medicinal products'. [ABSTRACT FROM AUTHOR]

Social policies have evolved to address the associated concerns related to the public health crises of drug abuse and undertreated pain. Prescription monitoring programs (PMPs) have been used for many years in this effort but are undergoing re-evaluation and restructuring in light of changes in technology as well as changes in our understanding of the collateral impact of such programs. We reviewed the state of PMPs in the United States and highlighted recent changes in these programs that have occurred nationally. The current changes occurring in California, with the most physicians of any U.S. state as well as the oldest triplicate-based serialized prescription program, are reviewed, with focus on the transition to tamper-resistant prescriptions that use security paper forms. Future trends for PMPs are described, including the potential for widespread use of electronic prescribing, which is gaining favor with the Drug Enforcement Agency. [ABSTRACT FROM AUTHOR]

Despite the widespread use of the drug court model, standardized performance measures for drug courts are not uniformly utilized, and rarely include process measures. To ensure that drug courts are being implemented in the most effective manner, the use of performance measurement tools should be considered for wide scale adoption. Drug court effectiveness is moderated by participant characteristics, and is most effective for individuals with the highest substance use needs. Therefore, having quality clinical screening processes is crucial to ensuring that drug courts are serving the population for which they are effective. This paper examines clinical screening in drug courts, to answer the following 1) what is the current state of screening, 2) what works, and 3) why measurement matters. It also proposes a clinical screening performance measure to improve fidelity and ensure appropriate participant enrollment. The creation of a performance measure would create opportunities to improve drug court outcomes, and leverage pay-for-performance models. [ABSTRACT FROM AUTHOR]

Background: Psychiatric research in the 1950s and 1960s showed potential for psychedelic medications to markedly alleviate depression and suffering associated with terminal illness. More recent published studies have demonstrated the safety and efficacy of psilocybin, MDMA, and ketamine when administered in a medically supervised and monitored approach. A single or brief series of sessions often results in substantial and sustained improvement among people with treatment-resistant depression and anxiety, including those with serious medical conditions. Need and Clinical Considerations: Palliative care clinicians occasionally encounter patients with emotional, existential, or spiritual suffering, which persists despite optimal existing treatments. Such suffering may rob people of a sense that life is worth living. Data from Oregon show that most terminally people who obtain prescriptions to intentionally end their lives are motivated by non-physical suffering. This paper overviews the history of this class of drugs and their therapeutic potential. Clinical cautions, adverse reactions, and important steps related to safe administration of psychedelics are presented, emphasizing careful patient screening, preparation, setting and supervision. Conclusion: Even with an expanding evidence base confirming safety and benefits, political, regulatory, and industry issues impose challenges to the legitimate use of psychedelics. The federal expanded access program and right-to-try laws in multiple states provide precendents for giving terminally ill patients access to medications that have not yet earned FDA approval. Given the prevalence of persistent suffering and growing acceptance of physician-hastened death as a medical response, it is time to revisit the legitimate therapeutic use of psychedelics. [ABSTRACT FROM AUTHOR]

Since the 1980s, the pharmaceutical industry has benefited substantially from a series of policy changes that have strengthened the patent protection for brand-name drugs as a result of the industry's political influence. This paper incorporates special interest politics into a quality-ladder model to analyze the policy-makers' tradeoff between the socially optimal patent length and campaign contributions. The welfare analysis suggests that the presence of a pharmaceutical lobby distorting patent protection is socially undesirable in a closed-economy setting but may improve social welfare in a multi-country setting, which features an additional efficiency tradeoff between monopolistic distortion and international free riding on innovations. [ABSTRACT FROM AUTHOR]

Drawing from data obtained in a comparative study of US district courts' criminal justice practices, this paper examines adjudication processing responses at the intersection of immigration and drug offences in a Southwestern federal district court, where the logic of immigration enforcement subsumes more traditional federal drug law enforcement. I demonstrate how characteristics of 'drug cases' are constructed at this intersection in such a manner that they stand apart from the prototypical federal drug case, and more closely resemble criminal immigration cases. I argue that in this border jurisdiction, the prevailing adjudicatory logic is concerned with defendants' status as unauthorized outsiders such that these defendants are barely distinguishable from immigration defendants in how their sentences are calculated and rhetorically justified. [ABSTRACT FROM AUTHOR]

Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programme (EAP).The regulations regarding EAPs is not the same all over the world. For example, the recommendation of the European Medicines Agency (EMA) in EU countries also includes within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment. Nevertheless, the patients treated in a clinical trial could have the option of continuing treatment for an extended period in an Open-label Extension study, aimed to generate long-term data on efficacy, safety, tolerability and administration.The aims of this paper - based on the difficulties and incoherence encountered by an Italian Ethic Committee (EC) during the authorisation process of EAPs - are: understanding the origin of this misclassification by analysing differences and similarities among USA, European and Italian regulations concerning EAPs; and showing difficulties in classifying international study protocols as a consequence of the lack of harmonisation of definitions.We performed a critical review of the current USA, European and Italian regulations and we analysed some practical cases by retrieving protocols from Clinicaltrials.gov and the Italian Clinical Trials Registry (OsSC) containing in the title the keywords 'Expanded Access Programme', "'Expanded Access', 'Open-label Extension study' or 'Early Access'.We observed that the Food and Drug Administration ( FDA) definition of EAP is very clear while the EMA definition is similar to that of an Open-label Extension study. This lack of a clear definition generates misclassification and it is possible to find an EAP with an efficacy or safety endpoint; or an EAP managed as a clinical trial; or an EAP classified in Clinical Trials Registries as a phase II, III or IV clinical trial.The internationalisation of the studies requires a harmonisation on a global level of legislation and definitions to eliminate misclassification of protocols. For this reason, the authors suggest that: a) the EMA definition should be harmonised with the FDA definition of EAPs, b) European regulation, even if optional, should be adopted in a compulsory way by national regulations. Moreover, separate registries for both EAPs and clinical trials should be organised. [ABSTRACT FROM AUTHOR]

This paper describes ways to approach the conceptual and practical challenges associated with interpreting the clinical meaning of scores produced by patient reported outcome (PRO) questionnaires, particularly when used to inform efficacy decisions for regulatory approval for oncology products. Score interpretation estimates are not inherent to PRO questionnaires per se, instead, vary dependent upon sample and study design characteristics. Scores from PRO measures can be interpreted at the individual and group level, and each carries its own set of statistics for evaluating differences. Oncology researchers have a variety of methods and data analytic strategies available to support their score interpretation needs, which should be considered in the context of their a priori knowledge of the target patient population, the hypothesized effects of treatment, the study design and assessment schedule, and the inferences and decisions to be made from the PRO data. [ABSTRACT FROM AUTHOR]

Correct use of terms in a manuscript or policy statement is important to meet the objectives of the paper. Inappropriate terms can be counter-productive. The World Health Organization (WHO) recommends the following: 'Terminology in national drug control legislation and policies should be clear and unambiguous in order not to confuse the use of controlled medicines for medical and scientific purposes with misuse' and terminology should always be respectful. This commentary lists English language terminology that can impair access to controlled medicines for the treatment of pain and suffering (an objective of the international substance control conventions), including pain management and the treatment of opioid dependence. The commentary also suggests alternative wording. Assessment of terminology correctness is language sensitive and should therefore be conducted by native speakers. In all language communities, advocates should explore and discuss the terminology with health-care professionals and their clients/patients, and they should promote the use of correct vocabulary. [ABSTRACT FROM AUTHOR]

An increase in new drugs first launched in the U.S. and shorter lags between first global drug launch and U.S. approval indicate that the U.S. drug lag has declined. This paper examines the impact of these changes on drug safety using adverse drug reaction data for FDA-approved drugs in 1990 to 2004. Results show two different effects. First, drugs having longer U.S. launch lags (more foreign market experience) have fewer post approval drug risks compared to drugs with shorter launch lags. This result implies that foreign market experience prior to U.S. entry provides information to help alleviate drug-related risks for U.S. patients. Second, drugs that are first launched in the U.S. have fewer serious drug reactions compared to those that were first launched abroad. This result is surprising, and may suggest that first U.S. drug launch signals information about unobserved application quality, which translates into lower post approval drug risks. [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]

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]

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]

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]

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.

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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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]

The article describes the papers presented at the conference 'Regulation of Medical Innovation and Pharmaceutical Markets' held at the University of Chicago, Illinois on April 20-21, 2001. The conference brought together leading economic experts on the U.S. pharmaceutical industry to discuss policy issues facing the industry. The policy focus of the conference was motivated by the fact that medical innovation and pharmaceutical markets have been subject to substantial public intervention in terms both of regulation and of fiscal subsidies and taxes. Put together, these papers illustrate the large and important set of policy questions that continue to face the regulation of this industry.

This paper examines efforts by the National Institute of Justice (NIJ) to expand our understanding of drug use among the arrestee population in largely rural states located the western portion of the country. The model for this new effort was the Drug Use Forecasting (DUF) program that was initiated by NIJ in the late 1980s. This program collected interview and urine data from recent arrestees in 23 large urban cities. The DUF program was enhanced to create a better understanding of the drug problem among arrestees in relatively smaller cities located in theoretically interesting areas. The new program (the Arrestee Drug Abuse Monitoring program [ADAM]) has involved the addition of 15 new sites and changes to the survey instrument, sampling design, and outreach that have helped show more clearly how the drug use patterns among arrestees differ from region to region. In this paper, specific attention is shown to one of the new sites (Oklahoma City) and regional comparisons. [ABSTRACT FROM AUTHOR]

The U.S. Congress passed a new law (PL 101-508) in 1990 requiring the pharmaceutical manufacturers to grant rebates on prescription drugs sold at retail under the federal Medicaid program. The goals include containing Medicaid program costs and expanding access of the indigent to ethical drug treatments. This paper evaluates the impact of HCFA's mandatory federal upper limit (FUL) prices on the retail sales volume of prescription drugs during 1994. Data of the most frequently dispensed drugs, as measured by the National Prescription Audit of IMS America, are used. Regression model results suggest that the competing drug prices impact sales significantly, and Medicaid drug rebates expand access to drug interventions by stimulating retail transactions. Prescription sales are also own-price insensitive (inelastic) in Medicaid and non-Medicaid market segments. The implications of extending Medicaid prescription drug rebates policy to enrollees in the traditional Medicare program are examined. [ABSTRACT FROM AUTHOR]

This paper presents a case study in the production and interpretation of regulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) — the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissive in the USA than in the UK. Six principal socio-political factors are put forward to explain this: differential regulatory trust; regulators' socio-technical data selections; medico-scientific disciplinary influences; organizational and professional interests; conflicts of interest of expert advisers; and the growth of the neo-liberal regulatory state. The risk assessments of both the British and American regulatory agencies are shown to be complacent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manufacturers and patients diverge, regulatory assessments are crucially affected by whether regulators are predisposed to award the benefit of the scientific doubts to the manufacturers or patients, and by the balance of such predispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British and American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely manner and, as a consequence, compromise patients' interests. Some policy implications for drug regulation are sketched. [ABSTRACT FROM AUTHOR]

Background: The regulatory environment is one of the key factors in successfully bringing an innovative medical product, like a drug-device combination product, to market. This paper offers insight into the experiences of those involved in obtaining regulatory approval of drug-device combination products in the European Union and the United States. Methods: The research consisted of two phases, qualitative data collection (through semi-structured interviews) and analysis, followed by quantitative data collection (through an online survey) and analysis. Results: A conceptual model was developed that depicted the facilitating factors for obtaining regulatory approval of a drug-device combination product, relevant to the European Union and United States systems, respectively. Conclusions: This model provides, for the first time, a comprehensive understanding of these factors, providing a foundation that could be adapted to reflect specific drug-device combination products. This research demonstrated originality of approach in interviewing thought leaders in the life sciences sector as well as conducting a survey that spans two of the largest jurisdictions for drug-device combination products in the world. [ABSTRACT FROM AUTHOR]

Over the past decade there has been a clear consensus among drug policy researchers that the practice of incarcerating persons for drug offenses has been counterproductive. As a result, U.S. criminal justice policy is increasingly emphasizing alternative dispositions to incarceration for drug related arrests. In addition, large numbers of persons currently incarcerated for drug related offenses are being released into communities. However, there are serious questions about where these individuals are going to live once released and how they will access needed services. Residential recovery homes in the community are good options for those who wish to pursue abstinence from drugs. They provide a drug- and alcohol-free living environment along with social support for abstinence and successful functioning in the community. This paper reviews recent changes in drug policy the U.S. and describes the variety of recovery home options that are available to persons diverted or released from incarceration. [ABSTRACT FROM AUTHOR]

In the wake of dramatic increases, and demographic shifts, in the misuse of heroin and prescription opioids, drug addiction and accidental overdose have been increasingly framed as public health, not criminal justice, matters in the United States. In turn, many locales hardest hit by fatal overdose have supported so-called 'harm reduction' policies aimed at stemming opiaterelated mortality, while openly disclaiming the propriety of strategies that punish users. Yet, as U.S. overdose deaths achieved another record high in 2015, individual users continue to fear the criminal ramifications of witnessing and even suffering an overdose. Using surveys and interviews among a sample of overdose-experienced individuals outside Pittsburgh, PA, this study reveals a marked reluctance among those at the scene of an overdose to involve emergency services, for fear of not only maltreatment, but also prosecution on homicide charges - a fear revealed to be welljustified in light of the increasing implementation and enforcement of 'fatal drug delivery' laws. Reflecting on Jonathan Simon's depiction of the U.S. as a society 'governed through crime,' this paper considers how an emergent 'war on overdose' may serve to buttress and quietly sustain an unpopular 'war on drugs' through alternative tactics that identify new victims and offenders. [ABSTRACT FROM AUTHOR]

Using the case of synthetic cathinones (commonly referred to as 'bath salts' in the US context), this paper analyses structural factors surrounding novel psychoactive substances (NPS) as contributing to the unique risk environment surrounding their use. Drawing on interviews with 39 people who use bath salts from four U.S. cities and analysis of the infrastructural, social, economic, and policy contexts, we document the unique harms related to changing contexts for illicit drug regulation, manufacture, and consumption. Findings suggest that NPS and designer drug markets, which are highly reliant upon the internet, share characteristics of the entertainment industry which has come to rely more heavily upon profits derived from the 'long tail' of myriad lesser-known products and the diminished centrality of 'superstars' and 'hits'. Findings point toward increased theoretical and policy attention to changing drug market structures, more rigorous evaluations of drug 'analogues' legislation and greater involvement with NPS education and testing by harm reduction agencies. [ABSTRACT FROM AUTHOR]

Policy PointsPeople are dying at record numbers from overdose in the United States.Concerted action has led to a number of successes, including reduced inappropriate opioid prescribing and increased availability of opioid use disorder treatment and harm‐reduction efforts, yet ongoing challenges include criminalization of drug use and regulatory and stigma barriers to expansion of treatment and harm‐reduction services.Priorities for action include investing in evidence‐based and compassionate policies and programs that address sources of opioid demand, decriminalizing drug use and drug paraphernalia, enacting policies to make medication for opioid use disorder more accessible, and promoting drug checking and safe drug supply. [ABSTRACT FROM AUTHOR]

The article explores what addiction specialists in the United States might learn from Estonia regarding their response to problems relating to drug addiction and overdose. Particular focus is given to the use of fentanyl, which has been a major contributor to the overdose death epidemic in both Estonia and the United States. Other topics discussed include methodologies for harm reduction, the development of early warning systems (EWS) that can inform users of the dangers and harms of new fentanyl analogues, and the effectiveness of naloxone.