The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements.

The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated, and introduced in the market. The regulatory classification of any IDDS, as a 'drug', 'medical device' or a 'combination product', is the cornerstone in determining the regulatory pathway, which decides the quality control requirements preceding the marketing approval. IDDSs are generally recognized as combination products as they consist of two or more regulated components (drugs, medical devices or biological products) combined prior to use to function as a single entity. Although robust and defined US FDA regulatory pathways exist for each component independent of one another, the regulatory pathways for combination products are less formalized.

Is multi-level marketing of nutrition supplements a legal and an ethical practice?

BACKGROUND: Multi-level marketing (MLM) of nutrition products has experienced dramatic growth in recent decades. 'Wellness' is the second most popular niche in the MLM industry and represents 35% of sales among all the products in 2016. This category includes dietary supplements, weight management and sports nutrition products. The aim of this paper is to analyse whether this practice is legal and ethical. METHODS: An analysis of available documentary information about the legal aspects of Multi-level marketing business was performed. Ethical reflexion was based on the "principlism" approach. RESULTS: We argue that, while being a controversial business model, MLM is not fraudulent from a legal point of view. However, it is an unethical strategy obviating all the principles of beneficence, nonmaleficence and autonomy. What is at stake is the possible economic scam and the potential harm those products could cause due to unproven efficacy, exceeding daily nutrient requirements and potential toxicity. The sale of dietary and nutrition supplements products by physicians and dieticians presents a conflict of interests that can undermine the primary obligation of physicians to serve the interests of their patients before their own. CONCLUSION: While considering that MLM of dietary supplements and other nutrition products are a legal business strategy, we affirm that it is an unethical practice. MLM products that have nutritional value or promoted as remedies may be unnecessary and intended for conditions that are unsuitable for self-prescription as well.

Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.

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.

Biosimilars: from technical to pharmacoeconomic considerations. 30th Rencontres Nationales de Pharmacologie et Recherche clinique pour l'Innovation et l'Evaluation des Technologies de Santé. Tables rondes.

A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.

[Internet presence of neurologists, psychiatrists and medical psychotherapists in private practice]. / Internetauftritte niedergelassener Neurologen, Psychiater und ärztlicher Psychotherapeuten.

OBJECTIVE: The world wide web provides new options to physicians in terms practice marketing, information brokerage, and process optimization. This study explores prevalence and content of homepages of neurologists, psychiatrists and medical psychotherapists in private practice. METHODS: Through the legal bodies of physicians in private practice in six northern German states neurologists, psychiatrists and medical psychotherapists were identified. According to a standardized and operationalized criteria catalogue, homepages were rated. RESULTS: 1804 physicians were identified, 352 (19.5 %) had operated a homepage. Higher frequencies of homepages found for male physicians (vs. female physicians), practice centres (vs. single practices) and urban practices (vs. rural practices). In average, practices reached 18.8 (±â€Š5.3) of 42 points; contact data and accessibility information were generally available; information as to qualification and specialization was provided more infrequently. Legal specifications were not considered in more than every second homepage, interactive elements like online appointment of follow-up prescription were only rarely offered. CONCLUSIONS: Only every fifth neurological or psychiatric practice operates an own homepage, higher competition (urban area) and higher professionalization (practice centres) seem to act as promotors. The legal framework has to be focused, and patient needs should be taken into account.

A case study of infant health promotion and corporate marketing of milk substitutes.

The mismatch between the demand for, and supply of, health products has led to the increasing involvement of courts worldwide in health promotion and marketing. This study critically examines the implementation of one country's Milk Code within the framework of the International Code of Marketing of Breast-Milk Substitutes, and the efficacy of the judicial process in balancing corporate marketing and state regulatory objectives. Drawing upon the Philippine experience with its own Milk Code, it evaluates the capacities of courts to determine policy costs and risks against the benefits of delineating and containing corporate marketing strategies for milk substitutes and supplements. The study finds that the methodological and information-based challenges faced by courts in resolving multi-dimensional health issues may not be overcome without serious questions concerning the legitimacy of the judicial process itself. Despite the deficiencies of litigation and adjudication, the study notes the catalytic potential of a judicial decision in opening up vital policy space for future renegotiations among rival parties and interests. Third-party intervention is explored relative to this catalytic function.

The unregulated commercialization of stem cell treatments: a global perspective.

Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies' marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

Environmental risk assessment for medicinal products containing genetically modified organisms.

Many gene therapy medicinal products and also some vaccines consist of, or contain, genetically modified organisms (GMOs), which require specific consideration in the environmental risk assessment (ERA) before marketing authorisation or clinical trial applications. The ERA is performed in order to identify the potential risks for public health and the environment, which may arise due to the clinical use of these medicinal products. If such environmental risks are identified and considered as not acceptable, the ERA should go on to propose appropriate risk management strategies capable to reduce these risks. This article will provide an overview of the legal basis and requirements for the ERA of GMO-containing medicinal products in the context of marketing authorisation in the EU and clinical trials in Germany. Furthermore, the scientific principles and methodology that generally need to be followed when preparing an ERA for GMOs are discussed.

Use of inappropriate titles by New Zealand practitioners of acupuncture, chiropractic, and osteopathy.

AIM: This study aimed to explore whether practitioners of acupuncture, chiropractic, and osteopathy use the title 'Doctor' in a way which could imply that they are registered medical practitioners, when there is no evidence that they are, and if so, whether rates differ between practice types. METHOD: Secondary data, the New Zealand Yellow pages telephone directory, were analysed for potentially misleading use of the title 'Doctor'. RESULTS: Some practitioners of acupuncture, chiropractic, and osteopathy appeared to use the title 'Doctor' in a way that could imply that they are registered medical practitioners, when there was no evidence this was in fact true. This occurred significantly more often among chiropractics than acupuncturists or osteopaths. CONCLUSION: Practitioners should be aware that if they are not registered medical practitioners, then using the title 'Doctor' whilst working in healthcare is unlikely to comply with the Health Practitioners Competence Assurance Act 2003. Misleading use of the title 'Doctor' should therefore be discontinued at the first available opportunity.

[What are the economic advantages of Integrated Health Care?]. / Wo liegen die Chancen der Integrierten Versorgung aus ökonomischer Sicht?

Integrated Health Care and Managed Health Care are both tools to implement broader responsibilities of health care providers for the economic efforts of their activities. While Managed Care is quite common in the United States of America, experiences with such systems are sparse in Europe and Germany. With Integrated Health Care, new types of markets will emerge: not only a market for health care services, but also for insurance contracts, and for provision of care. The paper discusses different incentives arising from different health care systems.