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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.

There are two main objectives of this paper. The first is to analyze household consumption pattern of soyfood products. The second is to investigate effect of the United States Food and Drug Administration (FDA) allowed health claims on consumption of soyfoods.

The objectives were accomplished in two stages. In the first stage, the role of consumers' perceived attributes of soy‐based foods such as convenience of preparation and consumption, health benefits, and taste in consumers' decisions to consume soy‐based food products was investigated. In the second stage, the study analyzed whether the decision of the Food and Drug Administration to allow food manufacturers to use health claims had influenced consumers' willingness to participate in soy‐based food market or willingness to increase consumption, if they are currently consuming such foods. Lancaster's characteristics model was combined with Fishbein's multi‐attribute model to develop a soybean demand function that included perceived attributes of soyfood. Zero‐inflated negative binomial model (ZINB) was used as an empirical specification to address zero consumption of soyfood products. Data were collected using a convenience sample drawn from a Midwest college town in the United States. Two questionnaires (i.e. one with information about the FDA's decision and the other without it) were given to students taking introductory marketing courses. In total 400 questionnaires were distributed and 315 respondents returned completed questionnaires.

Attributes of soy‐based food products such as convenience and tastefulness had statistically significant effect on the consumption pattern. Consumers who perceived beneficial health attributes in soyfood products were more likely to participate in the soyfood market as well as increase consumption frequency. The results indicated that frequent users of soyfood products who were exposed to the decision of the FDA would be more inclined to increase their consumption of soy‐based foods as compared to those who were not exposed to such information. Yet the information about FDA's decision did not influence the behavioral intentions of infrequent consumers or non‐consumers.

Research evaluating the impact of government allowed health claims on food consumption pattern is scarce. This paper sets up a platform for carrying out the evaluation of such health claims by other food products.

The Food Safety Modernization Act (FSMA), designed to establish and enforce food-safety standards for foods from domestic and foreign origins, focuses federal regulation on the prevention of food contamination. Many concerns have been expressed about how FSMA-compliance costs will affect the economic viability of very small and small farms, which have higher average compliance costs than do larger farms, thus marginalizing their ability to compete in the marketplace. The purpose of this study is to estimate how FSMA will affect differently sized US and international tomato producers in the fresh-tomato industry. A simulation approach is applied for changes of quantities demanded, revenues, and profits for differently sized farms based on elasticities estimated using a differential approach. Our findings indicate that both domestic and foreign tomato producers with both very small and small farms are expected to see significant losses in profit after the adoption of FSMA. The practical implications of these findings are that the Food and Drug Administration (FDA) should be aware of, be concerned about, and take into consideration the adverse consequences of their regulatory decisions on food prices, food-industry costs, the structure of the food industry, and product diversity. In essence, the FDA needs to strike a balance between food safety (the primary objective of FSMA) and market performance.

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices.

The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals.

The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals.

This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

Newly marketed drugs present unavoidable risks, no matter how diligent the level of pre-market review. Numerous adverse drug events attest to the need for post-market vigilance. However, the Food and Drug Administration monitors drugs with considerably less rigor after launch than before. This burdens both public health and public trust in the safety of new medicines. As new technologies such as genomics guide a larger share of drug development, the issue will become more acute. Most reform proposals present considerable logistical challenges. A promising alternative is to harness existing managed care databases to search for drug effects.

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.

The Bureau of Economics in the Federal Trade Commission has a three-part role in the Agency and the strength of its functions changed over time depending on the preferences and ideology of the FTC’s leaders, developments in the field of economics, and the tenor of the times. The over-riding current role is to provide well considered, unbiased economic advice regarding antitrust and consumer protection law enforcement cases to the legal staff and the Commission. The second role, which long ago was primary, is to provide reports on investigations of various industries to the public and public officials. This role was more recently called research or “policy R&D”. A third role is to advocate for competition and markets both domestically and internationally. As a practical matter, the provision of economic advice to the FTC and to the legal staff has required that the economists wear “two hats,” helping the legal staff investigate cases and provide evidence to support law enforcement cases while also providing advice to the legal bureaus and to the Commission on which cases to pursue (thus providing “a second set of eyes” to evaluate cases). There is sometimes a tension in those functions because building a case is not the same as evaluating a case. Economists and the Bureau of Economics have provided such services to the FTC for over 100 years proving that a sub-organization can survive while playing roles that sometimes conflict. Such a life is not, however, always easy or fun.

The issue of cloned food labeling came to the forefront on January 15, 2008, with the release of a controversial report by the Food and Drug Administration (FDA). This paper aims to explore issues surrounding cloned food sources, specifically the increasingly vocal demands by the American public for mandatory labeling.

This paper reviews literature to examine the culture and structure of the FDA over the past ten years. Ethical, economic and public health concerns surrounding cloned food sources are also examined. Comparisons are made to the shared history of genetically modified organisms (GMOs). Political process and implementation of the Cloned Food Labeling Act (S. 414) are explored.

The FDA faces legal and cultural pressure to speed medications to market. The processes created by this struggle also affect the regulation of agriculture; this can be seen in the similar histories of GMOs and cloned food. Ethical issues surrounding cloned food labeling include animal welfare and the usurpation of the creator's role. Other ethical issues are entwined in health and economic concerns. Health issues include the capacity of the FDA to track allergic reactions and the possibility of future protein abnormalities among consumers. Environmental and herd health are identified as more global health concerns.

The combined economics of the biotech cloning and agricultural industries invert the usual law of supply and demand. This economic dynamic may either hurt small farmers or potentially benefit those who eschew cloning due to ethical or financial constraints. The current political climate exerts an interesting dynamic on the cloned food labeling debate. Consumer issues are pushed aside in the excitement of a new administration and more pressing issues such as the recessed economy. Biotech industries have the ability to maintain focus in the midst of distracting national issues; however, legislative opponents may have newfound strength with a majority congress.

Functioning as an historical overview and theoretical framework for those studying cloned food safety and labeling issues, this paper is useful in engendering ethical discussions. It also highlights the need for statistical and public health research on cloned food safety.

Off-label drug prescribing by healthcare providers is a growing practice. Yet, the US Food and Drug Administration bans the marketing of drugs for off-label uses. In recent years, legal challenges by the pharmaceutical industry have chipped away government restrictions on off-label drug promotion. Although the changing legal landscape has been discussed, this paper aims to examine how key stakeholders and policy-makers might interact to provide a more transparent marketing environment for off-label drug discussions in the patient–provider relationship.

Drawing on a variety of sources, the authors assess the current marketing landscape of off-label drugs and some of the issues that challenge the healthcare provider–patient relationship. The authors then examine opportunities to improve the off-label promotion environment and the relevant decision-making theories that key stakeholders need to consider when formulating marketing efforts and policies.

The authors suggest that fewer restrictions on truthful, non-misleading off-label drug promotion provide an opportunity to improve drug knowledge and, importantly, healthcare provider and consumer decision-making. Key stakeholders should consider, among other solutions, criteria for defining truthful information on off-label drugs, alternative methods of approval of off-label uses and ubiquitous icons to identify off-label prescribing to all stakeholders.

Rather than rehash the legal landscape of off-label drug promotion, this paper focuses on how the healthcare provider–patient relationship is impacted and how stakeholders can improve information flow in this changing environment.

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.