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Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease‐related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice. [ABSTRACT FROM AUTHOR]

The Medicines and Healthcare products Regulatory Agency was established in April 2003 by the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). This paper describes the scientific and organizational basis for the merger and describes the various challenges facing this new Agency. [ABSTRACT FROM AUTHOR]

A balanced approach using an integrated combination of strategies, namely, demand reduction, supply reduction and harm reduction, was suggested to be implemented in a balanced way to the policy vision of a South Africa 'free of substance abuse'. Responding on the call for a comprehensive review of the National Drug Master Plan 2013–2017 to ensure consistency in policy approach, this article explores the integrative propositional analysis (IPA)‐based analysis to evaluate 'how systemic' and integrated were the policy strategies applied. The analysis draws insights from the internal consistency of the policy and provides complementary evidence on the systemic breakdown of the policy, which correlates with previous studies. The findings are indicative of the usefulness of the IPA‐based tools to more pragmatically develop policy that better reflects the systemic/integrated relationship of the three strategies based on their conceptual systemic integrity. This research has implications for interdisciplinary scholars and practitioners, of policy and theory. [ABSTRACT FROM AUTHOR]

Context Until the last decade of the 20th century, France had no equivalent to the US Food and Drug Administration. In this paper we describe and interpret the complex series of events that led to the passage by the French Parliament in December 1992 of a law incorporating such an agency, the Agence du Médicament (literally, 'medicines agency'). The broad aim of this project was to learn how public health policy change comes about by detailed analysis of a specific instance. More specifically, we aimed to better understand the circumstances under which public health crisis leads to significant public health policy reform. Methods This paper is based on detailed analysis of primary documents (eg, archived French health ministry papers, recorded parliamentary debates, government reports, newspaper articles) and oral history interviews covering a period from 1988 to 1993. Thematic analysis of these materials was initially grounded in theories of organizational change, moving to constructs that emerged from the data themselves. Findings Policy entrepreneurs positioned to frame adverse events and seize opportunities are key to public health policy reform. However, whether these entrepreneurs will have the requisite institutional power is contingent both on political structure and on the power of competing institutional actors. Health crises may catalyze institutional reform, but our analysis suggests that whether reform occurs, or even whether adverse episodes are labeled as crises, is highly contingent on circumstances of history, political structure, and political ideology and is extremely difficult to predict or control. Conclusions Actors positioned to shape public health policy need to have a detailed understanding of the circumstances that facilitate or impede policy reform. Health crises are now more often global than not. Comparative, theoretically grounded, cross-national research that looks in detail at how different countries respond to similar health crises would be extremely valuable in informing both policymakers and researchers. [ABSTRACT FROM AUTHOR]

The recent benefit–risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit–risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit–risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [ABSTRACT FROM AUTHOR]

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. [ABSTRACT FROM AUTHOR]

In their paper, Istvan and colleagues hint at the similarities between the regulation policies of flunitrazepam and zolpidem to draw conclusions about zolpidem's use. Indeed, of the about 1400 cases of hospitalization for addiction to high doses of benzodiazepines and the like in our institution, none were due to flunitrazepam, while more than half of them were due to lormetazepam. Https://doi.org/10.1007/s11739-020-02538-2 5 Lugoboni F, Bertoldi A, Casari R, Mantovani E, Morbioli L, Tamburin S. Adult attention-deficit/hyperactivity disorder and quality of life in high-dose benzodiazepine and related Z-drug users. [Extracted from the article]

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]

Breast cancer with bone metastasis accounts for serious cancer-associated pain which significantly reduces the quality of life of affected patients and promotes cancer progression. However, effective treatment using nanomedicine remains a formidable challenge owing to poor drug delivery efficiency to multiple cancer lesions and inappropriate management of cancer-associated pain. In this study, using engineered macrophage membrane (EMM) and drugs loaded nanoparticle, we constructed a biomimetic nanoplatform (EMM@DJHAD) for the concurrent therapy of bone metastatic breast cancer and associated pain. Tumor tropism inherited from EMM provided the targeting ability for both primary and metastatic lesions. Subsequently, the synergistic combination of decitabine and JTC801 boosted the lytic and inflammatory responses accompanied by a tumoricidal effect, which transformed the tumor into an ideal decoy for EMM, resulting in prolonged troop migration toward tumors. EMM@DJHAD exerted significant effects on tumor suppression and a pronounced analgesic effect by inhibiting μ-opioid receptors in bonemetastasismousemodels.Moreover, the nanoplatformsignificantly reduced the severe toxicity induced by chemotherapy agents. Overall, this biomimetic nanoplatform with good biocompatibility may be used for the effective treatment of breast cancer with bone metastasis. [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 development of specific drug therapy for children was a paradigm‐changing event that transformed paediatric medical practice. However, a series of tragedies involving drug treatment for children resulted in a gap developing between drug regulation and practice, with the majority of drugs used in child healthcare being used off‐label, rendering children therapeutic orphans. Over the past two decades changes in drug regulation led by the US Food and Drug Administration and followed by the European Union's European Medicines Agency have led to substantial changes in how new drugs with potential use in children are studied and labelled. While these changes have substantially improved labelling for new drugs, there has been much less progress with older drugs. Although the unique challenges of conducting clinical research in children have been addressed by novel clinical trial designs, many of these innovations have not been translated into approaches accepted for the drug approval process. The regulations applying to the need for paediatric studies currently are only applicable in the United States and the European Union, and there is less impetus for paediatric labelling in other jurisdictions. This impacts on a number of issues beyond labelling, including the availability of child‐friendly formulations. Finally, the impact of Brexit on paediatric drug studies in the UK remains unclear and is subject to ongoing negotiations between the UK government and the European Union. [ABSTRACT FROM AUTHOR]

Background: Clinical researches of stem cell‐based therapies are highly active in China, while it was arduous to determine the most effective way of clinical translation of those advanced therapies. Methods: This article briefly introduced the regulatory framework development, the progress in stem cell clinical researches and clinical trials of commercially developed stem cell‐based products, as well as the clinical review concerns of stem cell‐based products in China. Main findings: The current regulatory framework of stem cell clinical researches in China was launched in 2015, when regulatory authorities issued "Administrative Measures on Stem Cell Clinical Research" (AMSCCR) detailing the rules of stem cell clinical research. Thereafter, the rapidly growing stem cell clinical researches were rigorously managed and clinical use of stem cell therapy was halted. Meanwhile, commercially developed stem cell‐based products are supervised by Drug Administration Law (DAL). Conclusion: The regulatory framework of stem cell‐based therapy in China has progressed in the last few decades, which is currently regulated according to AMSCCR and DAL. Well‐designed and patient‐focused clinical trial is required for commercially developed stem cell‐based products, and definite clinical benefit evidence is crucial to obtain marketing authorization. [ABSTRACT FROM AUTHOR]

Policy PointsIn the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug–pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage.As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards.Prescription drug–pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation. Context: Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug–pricing boards to address the high prices of brand‐name prescription drugs and assess the value of those drugs. Methods: We identified state prescription drug–pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value‐based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. Findings: Six state drug‐pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state‐regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non‐Medicaid, state‐funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. Conclusions: Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug–pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards. [ABSTRACT FROM AUTHOR]

The impact of alternative drug policy objectives, specifically harm reduction/harm minimisation or prohibition, is unclear. The literature is confusing. This article conceptualises the causal connection between drug consumption and health harm (or reduced health status) then clarifies the implication of ‘drug related harm’. By applying some geometrical tools from economics, the choice of policy objective is analysed. The preferences of policy advocates are then incorporated. Policy advocates are conceived as arguing that decision-makers and consumers should adopt their preferences between drugs and health harm. With this approach, the difference between alternative drug policies, in particular prohibition and harm minimisation/reduction, is demonstrated. [ABSTRACT FROM AUTHOR]

We study tax and regulatory policy in the legal marijuana market using unique administrative data from Washington state. Washington's retail entry restrictions have resulted in firms with substantial market power who behave like local monopolists. We show how the presence of market power causes tax and regulatory policy recommendations to differ from standard models that assume perfect competition. Combining structural demand models with measured pass‐through, we show that marijuana is not overtaxed at 37% but is still on the upward sloping region of the Laffer curve and that these taxes have high social costs and are mainly borne by consumers. [ABSTRACT FROM AUTHOR]

Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 2018 to advanced therapy medicinal products originally developed by public bodies, we discuss most commonly raised issues and the complexity and timings of the questions posed. Earlier and more frequent SA could help advanced therapy medicinal product developers to pre‐empt delays at the marketing authorisation stage. Carefully addressing quality and nonclinical issues before entering the pivotal phase of development will clear the path for a smooth clinical development and successful marketing authorisation. [ABSTRACT FROM AUTHOR]

This paper estimates the impact of federal regulation of drug quality on research spending by the pharmaceutical industry. The theoretical approach recognizes that the effects of these regulations on research spending depend upon the reactions of R&D decision makers and the information available during project selection. The information available to R&D decision makers in the 1960s suggests that it would have been difficult for them to forecast accurately regulatory effects on research profitability. As better information developed in the late 1960s and early 1970s, however, regulation had a significant effect on research spending. These differences in response are tested econometrically and prove to be empirically significant. The estimates of current regulatory effects on pharmaceutical R & D spending are quite large. [ABSTRACT FROM AUTHOR]

Over the last few years, marijuana has become legally available for recreational use to roughly a quarter of Americans. Policy makers have long expressed concerns about the substantial external costs of alcohol, and similar costs could come with the liberalization of marijuana policy. Indeed, the fraction of fatal accidents in which at least one driver tested positive for tetrahydrocannabinol has increased nationwide by an average of 10% from 2013 to 2016. For Colorado and Washington, both of which legalized marijuana in 2014, these increases were 92% and 28%, respectively. However, identifying a causal effect is difficult due to the presence of significant confounding factors. We test for a causal effect of marijuana legalization on traffic fatalities in Colorado and Washington with a synthetic control approach using records on fatal traffic accidents from 2000 to 2016. We find the synthetic control groups saw similar changes in marijuana‐related, alcohol‐related, and overall traffic fatality rates despite not legalizing recreational marijuana. [ABSTRACT FROM AUTHOR]

Https://doi.org/10.1111/bcp.15497 The journey of drug development is a long and arduous one, even beyond drug approval. Medicines availability, prescribing, and utilization are impacted by costs, health policies/drug regulation, drugs, and therapeutic committees in the hospitals, patient-prescriber relationship, formulation ease, and finally the understanding gained by the patient themselves. Figures from the editors selected issue highlights will be displayed each month in the journal image carousel on the BJCP homepage http://bpspubs.onlinelibrary.wiley.com/hub/journal/10.1111/(ISSN)1365-2125/ Spoorthy. [Extracted from the article]

Good practices around model‐informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. A survey targeted to clinical pharmacology and pharmacometric colleagues across industry, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) was conducted to understand current and future roles of MID3. The documented standards were generally affirmed as a "good match" to current industry practice and regulatory expectations, with some identified gaps that are discussed. All have seen at least a "modest" step forward in MID3 implementation associated with greater organizational awareness and share the expectation for a future wider use and impact. The priority within organizations was identified as a limitation with respect to the future of MID3. Finally, potential solutions, including a global overarching MID3 regulatory guideline, to facilitate greater acceptance by industry and regulatory decision makers are discussed. [ABSTRACT FROM AUTHOR]

Noninferiority trials are used to assess whether the effect of a new drug is not worse than an active comparator by more than a noninferiority margin. If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one of the most challenging steps in the design of noninferiority trials. Regulators recommend that the margin should be defined based on the historical evidence of the active comparator (the latter is often the well-established standard treatment of the disease), which can be performed by different approaches. There are several factors and assumptions that need to be accounted for during the process of defining the margin and during the analysis of noninferiority. Three methods are commonly used to analyse noninferiority trials: the fixed-margin method; the point-estimate method; and the synthesis method. This article provides an overview of analysing noninferiority and choosing the noninferiority margin. [ABSTRACT FROM AUTHOR]

Repurposing Food and Drug Administration ( FDA)-approved drugs for a new indication may offer an accelerated pathway for new treatments to patients but is also fraught with significant commercial, regulatory, and reimbursement challenges. The Alzheimer's Drug Discovery Foundation ( ADDF) and the Michael J. Fox Foundation for Parkinson's Research ( MJFF) convened an advisory panel in October 2013 to understand stakeholder perspectives related to repurposing FDA-approved drugs for neurodegenerative diseases. Here, we present opportunities on how philanthropy, industry, and government can begin to address these challenges, promote policy changes, and develop targeted funding strategies to accelerate the potential of FDA-approved repurposed drugs. [ABSTRACT FROM AUTHOR]

Context The formation of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Special Action Office for Drug Abuse Prevention (SAODAP) in the early 1970s dramatically expanded scientific and medical efforts to control alcoholism and drug abuse in the United States. Methods Drawing on a variety of primary, secondary, and archival sources, this article describes the creation and early years of these agencies. Findings I show that while the agencies appeared at roughly the same time, their creation involved separate sets of issues and actors. In addition, I show that SAODAP received more money and resources, even though advocates for alcoholics mobilized a stronger lobbying campaign. Conclusions Two factors explain this discrepancy in money and resources: (1) alcoholism was framed as a public health problem, whereas drug abuse was drawn into broader debates about crime and social decline; and (2) alcohol programs relied on congressional support, whereas drug programs found champions at high levels of the Nixon administration. These political and cultural factors help explain why current programs for illegal drugs receive more federal support, despite alcohol's greater public health burden. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at a symposium sponsored by the Society of Chemical Industry (SCI) titled "2nd Forensic Science Symposium," is presented. Topics include analysis of artefacts from the Ballyhanna burial site, changes in legislations and uses of modern illegal drugs, and the role of the Forensic Laboratory, Ireland in explosive analysis. The symposium featured several forensic scientists including T. Bashir, E. Highes, and T. Hanngan.

Context: Vaccination in the United States is a frequent source of controversy, with critics alleging failures by public health officials to adequately identify, monitor, and respond to risks associated with vaccines. In response to these charges, the case of RotaShield, a vaccine withdrawn in 1999 following confirmation of a serious adverse event associated with its use, is regularly invoked as evidence of the effectiveness of current vaccine safety activities. Methods: This article examines the history of RotaShield, with particular attention paid to decision making regarding its use in the United States and internationally. I reviewed and analyzed federal advisory committee meeting transcripts, international conference reports, government and scientific publications, media coverage, and other primary and secondary source materials. I also conducted six semistructured interviews with former senior officials and advisory committee members at the U.S. Centers for Disease Control and Prevention who participated in decisions regarding the vaccine. Findings: Decision making regarding RotaShield, including the ultimate withdrawal of its recommendation for use, was shaped significantly by government health officials' concern for preserving public confidence in overall U.S. vaccination efforts amid several unrelated vaccine risk controversies ongoing at that time. This attention to public perception and external pressures occurred in tandem with the evaluation of the quantitative evidence regarding the magnitude and severity of the risk associated with the vaccine. The decisions made in the United States resulted in foreseen but unintended consequences for international use of the vaccine, including in nations where the profile of risks and potential benefits was dramatically different. Conclusions: As enthusiasm for evidence-based decision making grows throughout medicine and public health, greater explicit attention should be directed to the processes by which decision makers and their expert advisers evaluate such evidence and translate it into regulation and policy by means of qualitative judgments. [ABSTRACT FROM AUTHOR]

Clinical pharmacologists are the only medical specialists whose training focuses specifically on the safe, effective and cost-effective use of medicines, underpinned by an understanding of drug discovery, drug regulation, pharmacology, translational medicine and the performance of clinical trials. This unique perspective has allowed them to provide expertise and leadership in medicines regulation, medicines policy, health technology assessment and drug pricing. Clinical pharmacologists assisted in the creation of the Committee on Safety of Medicines (now the Commission on Human Medicines), the Yellow Card Scheme, the National Institute of Health and Clinical Excellence (NICE) and related organizations in Scotland and Wales, and contributed to clinical guidelines (through the Scottish Intercollegiate Guidelines Network) and the British National Formulary. Their research work has contributed substantially, through translational medicine and therapeutics, to the development of new medicines and, as a result, creation of health and wealth in the UK. Their work in medicines policy has served to protect patients from harms associated with the use of medicines. A reduction in the number of able junior doctors attracted to a career in clinical pharmacology, a reduction in the number of training posts, and an ageing population of academic trainers, puts the future of the specialty, and its contribution to patient safety and UK wealth creation, at substantial risk. Urgent measures are needed to convince the NHS and government that these essential skills should be protected and nurtured. [ABSTRACT FROM AUTHOR]

Context: With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market. Methods: This report provides an historical perspective on proposals for encouraging drug research. Four legislative programs have been primarily designed to offer market exclusivity to promote public health goals in the pharmaceutical or biomedical sciences: the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, the Hatch-Waxman Act of 1984, and the pediatric exclusivity provisions of the FDA Modernization Act of 1997. I reviewed quantitative and qualitative studies that reported on the outcomes from these programs and evaluated the quality of evidence generated. Findings: All four legislative programs generally have been regarded as successful, although such conclusions are largely based on straightforward descriptive reports rather than on more rigorous comparative data or analyses that sufficiently account for confounding. Overall, solid data demonstrate that market exclusivity incentives can attract interest from parties involved in drug development. However, using market exclusivity to promote innovation in the pharmaceutical market can be prone to misuse, leading to improper gains. In addition, important collateral effects have emerged with substantial negative public health implications. Conclusions: Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects. Certain practices, such as mechanisms for reevaluation and closer ties of incentives programs to public health outcomes, can help address these problems. [ABSTRACT FROM AUTHOR]

An introduction is presented for this issue which mentions articles about patient-centered care, the value of palliative care and hospice services, and the patient's experience of agency.

Objective. To assess legislation requiring drug companies to report gifts to providers, and to evaluate the information obtained. Data Sources. Data included legislation in Vermont, Minnesota, Maine, Massachusetts, West Virginia, and the District of Columbia, and company disclosure data from Vermont. Study Design. We evaluated the strengths and weaknesses of state legislation. We also analyzed 4 years of company disclosures from Vermont, assessing the value and distribution of industry–provider exchanges and identifying emerging trends in companies' practices. Data Collection Methods. State legislation is publically available. We obtained Vermont's data through requests to the state's Attorney General's office. Principal Findings. Of the state laws, only Vermont's yielded robust, publically available data. These data show gifting was dominated by a few major corporations, and <2 percent of Vermont's prescribers received 69 percent of gifts and payments. Companies were especially generous to specialists in psychiatry, endocrinology/diabetes/metabolism, internal medicine, and neurology. Companies increasingly used loopholes in the law to avoid public scrutiny. Conclusions. Disclosure laws are an important first step in bringing greater transparency to physician–industry relationships. But flaws and weaknesses limit the states' ability to render physician–industry exchanges fully transparent. Future efforts should build on these lessons to render physician–industry relationships fully transparent. [ABSTRACT FROM AUTHOR]

The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses (“on-label”), but does not require certification before physicians may prescribe the drug for subsequent uses (“off-label”). Does it make sense to require FDA efficacy certification for new drugs but not for new uses of old drugs? Using a sequential online survey, we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses; almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most physicians said no. We then asked respondents whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response, we received hundreds of written commentaries. We organize and discuss these commentaries with an eye to understanding how the medical market certifies off-label drug uses and how this compares to FDA certification. Does off-label medicine use suggest that efficacy requirements should be placed on new uses of old drugs? Does it suggest that efficacy requirements on new drugs should be lifted? We explore these questions, and ask whether the response of many of the doctors exhibits the familiar behavior bias toward the status quo. [ABSTRACT FROM AUTHOR]

Aim To determine changes in the availability, in terms of licensing and formulations, of medicines for children in the UK between 1998 and 2002. Methods Using the Association of British Pharmaceutical Industry (ABPI) Compendium of Data Sheets and Summaries of Product Characteristics (SPC) 1998 and the Medicines Compendium 2002, licensed medicines available in the UK in the calendar years 1998 and 2002 were examined. Results In 1998, 61% of chemical entities/fixed-dose combinations were licensed in some form for children compared with 64% in 2002. Of the chemical entities/fixed-dose combinations with oral formulations, 250 (33%) in 1998 had an oral formulation suitable for use by children and in 2002 there were 284 (34%). Of the 129 new chemical entities registered in the UK between 1998 and 2002, only 30 (23%) were licensed for under the age of 12 years and 19 (15%) for the neonatal age group. A total of 480 medicines licensed for children were withdrawn from marketing but only cisapride and primidone had no generic or therapeutic alternatives. Conclusion Although there was improvement in the availability of medicines for children in the UK over the 5-year period (1998–2002), considerable inequities still existed between children and adults. [ABSTRACT FROM AUTHOR]

A major state drug abuse initiative, California's Proposition 36 of 2000, mandated that adults convicted of drug possession be offered treatment in lieu of incarceration. While the law expanded public treatment for arrestees, the counties were given discretion in structuring their systems of care and procedures to manage clients. Using data from a study of key informants in eight counties, this article examines local planning to increase drug treatment capacity and manage clients' access to treatment. In both these planning domains, it describes the counties' strategies and concerns, reasons for their differences in approaches, and whether and how this state initiative, which explicitly incorporated treatment objectives into penal drug law, will shift the debate over drug abuse policy toward greater consideration of public health goals. [ABSTRACT FROM AUTHOR]

The legalization of drugs would prevent our civil liberties from being threatened any further, it would reduce crime rates, reverse the potency effect, improve the quality of life in the inner cities, prevent the spread of disease, save the taxpayer money, and generally benefit both individuals and the community as a whole. Our arguments are based on a basic appreciation of the benefits provided by voluntary exchange and the role markets play in coordinating human activities. Legalizing drugs would eliminate many inconsistencies, guarantee freedoms, and increase the effectiveness of the government's anti-drug beliefs. The present war on drugs has not and will not produce a decisive victory. We advocate a new approach to this important social problem. [ABSTRACT FROM AUTHOR]

Investigates the valuation effects of Food and Drug Administration (FDA) decisions on new products of firms that operate in the food and drug industries in the United States. Expected market values of approval of new products; Evidence of information leaks preceding FDA announcements; Association between FDA actions and stockholders' losses.

Discusses determinants of inter-country diffusion of pharmaceutical products. Factors influencing the pattern of diffusion of pharmaceutical products; Effect of drug regulations on the occurrence of drug lags; Impact of commercial forces on the supply of drugs to the world market.

Focuses on the problems associated with estimating the impact of the public disclosure of safety and effectiveness data submitted on behalf of a new drug in a premarket application in the United States. Case study on trade secret disclosure; Recommended integration of economic analyses for review of new drug applications.

Provides the background on the development of the legislative proposal in the United States called the Drug Regulation Reform Act of 1978. Assessment of the economic impact of the legislation on the pharmaceutical industry; Differences between the perceptions of the United States Food and Drug Administration (FDA) and critics on the drug bill; Factors that lead the FDA to its position on the bill.

The article discusses the process of evaluating new medicines in Europe conducted by regulatory authorities (RAs). It notes on the need for a greater transparency for medical regulations which has been advocated by public and scientific communities and is significant to understand the reasons on certain procedures for a successful or failed application. It indicates that the European Union (EU) has obliged the European Medicines Agency (EMA) to disclose information of drug applications.

The article discusses the practice of off-label prescriptions and new laws which encourage such. Defined as a legal practice by physicians who prescribe a drug meant for one malady to treat another, it states that off-label usage is common. It is illegal, however, for pharmaceutical companies to promote the practice, though a law exists allowing their sales people to distribute off-label research for other ailments. The costs involved for federal approval of a drug for other uses encourage the practice, as well as a company's need to maximize profits.

The article reports that drugs unrestricted by law which are called as legal highs are inspired by pharmaceutical research. It states that these drugs are different in chemical structure but provide the same effects of restricted drugs. Scientist advisor Ric Treble says that legal highs designers based their drugs on academic researches and medical journals. Moreover, government agencies along with United Nations and European Commission are performing efforts to stop legal highs production.

The article offers news briefs related to chemical industry. The U.S. introduces a bill that will place a framework for biosimilar drug approval. The European Union (EU) Directive 86/609 on bioscience research is being revised. It reports that chemical tankers MT Nipayia and MT Bow Asir were hijacked in a remote location off the coast of Somali.