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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.

Introduction: This paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.Objectives: To investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.Materials and Methods: We retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004-2006 and 2012-2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.Results: In 2004-2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012-2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004-2006 and seven in 2012-2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012-2014 compared with 2004-2006.Conclusions: The entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information. [ABSTRACT FROM AUTHOR]

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries? [ABSTRACT FROM AUTHOR]

Background Namibia is typical of low-income and middle-income countries with growing tobacco use, but with limited capacity to impose comprehensive tobacco control legislation. Despite initiating dialogue on national tobacco control policy in 1991, the country took nearly 20 years to pass the Tobacco Products Control Act. Objective To use Namibia as a case study to illustrate challenges faced by low-income countries working to forward tobacco control legislation. Method Face-to-face and telephonic interviews were conducted with 13 bureaucrats and advocates currently or previously engaged in tobacco-related work in Namibia. Tobacco-related news articles from national newspapers were examined. Results The constitutional obligation of the government to promote public health laid the foundation for Namibia’s tobacco control policy. Staff capacity constraints greatly delayed the passing of tobacco control legislation. It is unclear what influence the tobacco industry's involvement as a stakeholder had on policy; however, in at least one instance, the tobacco industry actively misled government. Namibia’s ratification of the Framework Convention on Tobacco Control was instrumental in passing legislation that meets most provisions of the international treaty. The media have generally played a supportive role in pushing the government to pass tobacco control legislation. Conclusions The fact that Namibia was able to pass fairly comprehensive tobacco control legislation with such meagre resources is commendable. The government must now implement the regulations that make the legislation effective. Tobacco control progress in low-income and middle-income nations can be encouraged through use of the media and improved staff and legal capacity within health ministries. [ABSTRACT FROM AUTHOR]

Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands. [ABSTRACT FROM AUTHOR]

Many new drugs in the future will be very expensive and have major resource implications. Given current structures and legislation covering the prescribing of drugs, there are no clear means of controlling the use of these drugs to avoid diverting money away from other health care services and into drug treatment. This paper considers what mechanisms might be used by a purchaser to manage the introduction of an expensive new drug and uses interferon beta-1b for treating multiple sclerosis as an example. The most likely mechanism is the prescribing of the drug by a general practitioner on the advice of a neurologist. This would achieve a good benefit for the resources invested but would not control total expenditure. Devolving a limited budget for the drug to a specialist centre so that neurologists may prescribe it directly would be preferable, as this would link clinical, prescribing, and budgetary responsibility. These issues need to be addressed urgently by purchasers if major disruptions of services are to be avoided. [ABSTRACT FROM AUTHOR]

The European Union (EU) Paediatric Regulation requires that all new medicinal products applying for a marketing authorisation (MA) in the EU provide a paediatric investigation plan (PIP) covering a clinical and non-clinical trial programme relating to the use in the paediatric population, unless a waiver applies. Conducting trials in children is challenging on many levels, including ethical and practical issues, which may affect the availability of the clinical evidence. In scientifically justified cases, extrapolation of data from other populations can be an option to gather evidence supporting the benefit-risk assessment of the medicinal product for paediatric use. The European Medicines Agency (EMA) is working on providing a framework for extrapolation that is scientifically valid, reliable and adequate to support MA of medicines for children. It is expected that the extrapolation framework together with therapeutic area guidelines and individual case studies will support future PIPs. Extrapolation has already been employed in several paediatric development programmes including biological treatment for immune-mediated diseases. This article reviews extrapolation strategies from MA applications for products for the treatment of juvenile idiopathic arthritis, paediatric psoriasis and paediatric inflammatory bowel disease. It also provides a summary of extrapolation advice expressed in relevant EMA guidelines and initiatives supporting the use of alternative approaches in paediatric medicine development. [ABSTRACT FROM AUTHOR]

Focuses on the regulation of medicines in Great Britain. Significance of the 1968 Medicines Act; Impact of regulations on pharmaceuticals industry; Principles included in the 1993 white paper on open government.

For a significant number of patients, there exists no, or only little, interest in developing a treatment for their disease or condition. Especially with regard to rare diseases, the lack of commercial interest in drug development is a burning issue. Several interventions have been made in the regulatory field in order to address the commercial disinterest in these conditions. However, existing regulations mainly focus on the provision of incentives to the sponsors of clinical trials of orphan drugs, and leave unanswered the overarching question about the rightful place of orphan drugs in resource allocation systems. In this article, we analyse the ethical aspects of funding research and development in the field of rare diseases. We then propose an ethical framework that can help health policy makers move forward in the difficult matter of fairly allocating resources for the prevention, diagnosis and treatment of rare diseases. [ABSTRACT FROM AUTHOR]

The article focuses on improving access to medicines and empowering patients with amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND) in the quest to improve its treatment. Topics include orphan drug legislation, targeting drug development in rare diseases having not resulted in significant advances in therapies for ALS/MND in nearly 30 years since its inception and the view that offering unproven potential therapies was not exploitative.

The article discusses the suspended membership of the British subsidiary of the Japanese drug company Astellas in the Association of the British Pharmaceutical Industry due to allegations of deception on a grand scale.

The author explores his views on the need for the UK Advisory Council on the Misuse of Drugs and the 2016 United Nations General Assembly Special Session on Drugs to reclassify psychedelic drugs as schedule 2 compounds to enable an evidence based assessment of their therapeutic potential. Topics include the prohibition of psychedelic drugs in 1967 and the lack of evidence that psychedelic drugs such as lysergic acid diethylamide as habit forming.

The article reports on the agreement between drug company Cephalon and generic drug maker Teva wherein the drug company paid the generic drug maker to prevent the sale of the generic brand of the drug Provigil and mentions an overview of the patent infringement case filed by the drug company Cephalon against the generic drug maker Teva.

The article reports on a criminal prosecution held by Japanese regulators against the Swiss drug company Novartis for allegedly using falsified research in leaflets to promote the antihypertensive drug valsartan, which is marketed as Diovan, to doctors, as of January 2014.