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The study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.

The article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.

The results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.

In this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.

Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue.

Expert review.

Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA.

Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

The U.S. 2009 Tobacco Control Act opened the door for new antismoking policies by giving the Food and Drug Administration broad regulatory authority over the tobacco industry. We develop a behavioral welfare economics approach to conduct cost-benefit analysis of FDA tobacco regulations. We use a simple two-period model to develop expressions for the impact of tobacco control policies on social welfare. Our model includes: nudge and paternalistic regulations; an excise tax on cigarettes; internalities created by period 1 versus period 2 consumption; and externalities from cigarette consumption. Our analytical expressions show that in the presence of uncorrected internalities and externalities, a nudge or a tax to reduce cigarette consumption improves social welfare. In sharp contrast, a paternalistic regulation might either improve or worsen social welfare. Another important result is that the social welfare gains from new policies do not only depend on the size of the internalities and externalities, but also depend on the extent to which current policies already correct the problems. We link our analytical expressions to the graphical approach used in most previous studies and discuss the information needed to complete cost-benefit analysis of tobacco regulations. We use our model as a framework to reexamine the evidence base for strong conclusions about the size of the internalities, which is the key information needed.

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

The purpose of this paper is to explore ethical issues related to pharmaceutical marketers’ social media efforts including the prevalence and forms of direct-to-consumer web 2.0 advertising (eDTCA) and corporate social responsibility (CSR) messages across social networking sites (SNSs). One goal is to determine if these eDTCA posts comply with draft guidelines issued by the Food and Drug Administration (FDA).

Content analysis of ten pharmaceutical marketers’ SNS posts documented the frequency and types of posts devoted to eDTCA, drug risks and benefits, CSR, and other purposes.

eDTCA represents about 35 percent of all pharmaceutical firm SNS posts and primarily communicates help-seeking messages via Facebook, Twitter, and YouTube. Firms also promote their ethical image through CSR-related posts. These posts primarily highlight employee-focussed and community-focussed initiatives. Analysis of consumer behavior in response to each post shows that eDTCA affects only liking of YouTube videos, but CSR increases behavior responses on all SNSs except LinkedIn.

Despite absence of final guidance, pharmaceutical marketers seem to abide by FDA draft social media guidance. In line with the FDA’s draft fair-balance regulations, almost all product-claim eDTCA posts state both benefit and risk information. Nevertheless, the FDA should issue final eDTCA guidance without delay consistent with traditional media direct-to-consumer advertising guidance. This should benefit consumers through consistency with their existing advertising literacy competencies.

The study represents an initial attempt to document ethical issues in the current state-of-the-practice of pharmaceutical social media marketing related to eDTCA and CSR.

Pre‐employment medical examinations with appropriate testing are required in many industries—a basic tenet of Occupational Medicine—and it has long been a recommendation of many in community medicine and environmental health for those food handlers whose close contact with open food, aspects of its preparation, processing, sale, exposure for sale, make their personal health important and in prevention of diseases and may constitute a health hazard to food consumers. Epidemiological studies have revealed too many instances of a human source of disease, especially in milk and water, for this to be denied or under‐estimated. Food poisioning outbreaks caused by a carrier, of chronic or limited duration, enable those investigating such outbreaks to see there could be advantages in medical screening of certain employees especially in certain areas of food trades. The main problem is to decide the extent of the discipline and who should be subject to it. The fact that by far the majority of the examinations and tests will prove negative should not be seen as removing the need for the service. After all, there are a number of similar circumstances in public health. Meat inspection, for example, in which a 100% inspection of all food animals slaughtered for human food is now fully established, it is not suggested that inspections should in any way be reduced despite the fact that a number of the diseases, eg., tuberculosis, no longer occurs as it once did, which was the prime cause of meat inspection being brought into being. Other areas where routine medical examinations reveal satisfactory health with only a few isolated cases requiring attention, is the school medical service. Here, the “de‐bunkers” have had some success, but if children are not regularly examined at vulnerable age levels and especially in between where the occasion demands, there is no question that much will be missed and ill‐health progress to a chronic state.

The purpose of this paper is to analyze the US food industry supply chain based on a case study of a leading US global processed food manufacturer to determine areas for improvement in the recall process to reduce the possibility of harming consumers with unsafe products.

Current US Food and Drug Administration and US Department of Agriculture regulations were evaluated to understand the minimum requirements placed upon members of the supply chain within the US food industry. Thereafter, a situation analysis was conducted followed by a cause and effect analysis to illustrate weaknesses within typical recall procedures. Substantiation of the analysis was based on specific information provided by managers from various functional areas of the processed food manufacturer in their interviews and their perspective about the recall/traceability process and its complexities.

Improvement concepts considered were: the implementation of Radio Frequency Identification Technology (RFID); the Food Marketing Institute (FMI) Recall Portal; and standardized global regulations within the food industry. Various phases of RFID are being piloted within the US food industry, but are not yet being widely studied due to the lack of immediate implementation requirements. Specific results pertaining to the FMI Recall Portal are not available due to its recent launch. Research indicated various regulatory processes implemented in individual countries, but no global standards have been agreed upon and initiated.

The improvement ideas have implications for timely communication among supply chain partners, resulting in less contaminated product in the hands of consumers. The ability to make these improvements will require collaboration among global suppliers through global regulations and top management support.

Understanding the gaps within current regulations and emphasizing the global footprint of how the food industry truly transformed itself into a global marketplace. Future studies need to focus on the cost impact of full RFID implementation across the entire food industry, with an understanding of cost burden ownership and worldwide integration.

The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical trials in the United States. In recent years, an increasing number of clinical trials have shifted from academic medical centers, to community‐based practices, to global sites in different countries. Contract research organizations (CROs) are service organizations that provide research and support services to pharmaceutical, biotechnological, and health companies. This paper aims to explore the evolution of the CRO industry in the United States and worldwide, and to discuss the benefits and pitfalls of the globalization of CROs.

The organizational ecology framework is used to analyze the lifecycle of CROs in response to their environment including their emergence, growth, and evolution to date.

The authors discuss the drug development process, the role of CROs and outsourcing in clinical research. Pharmaceutical companies began outsourcing research activities to increase their profit margins and better position themselves in the rapidly‐changing healthcare environment. The paper analyzes the evolution of the CROs over time and the factor that affected it, including the current globalization stage with special emphasis in India, China and Central and Eastern Europe. Consequences of globalization include the stimulation of research collaboration, policy and issues related to quality.

The evolution of CROs over time points to transformation/evolution of these organizations, with challenges as they become an integral part of the drug development process in the USA and other countries.

Explains the guidelines which exist for food packaging and inserts printing inks used in direct food contact. Provides a brief review of the use of promotion in packaging and goes on to look at the three methods of manufacturing the in‐packs. Assesses the present situation in European food packaging legislation and provides a checklist for the food contact printer. Also looks at the viability of wide web flexible packaging and UV inks and coatings.

The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.

When a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.

Establishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.

This is an original paper written for the Third Canadian Quality Congress.