Search results

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.

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.

In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in the treatment of certain types of cancer and cases of HIV/AIDS, the Celgene corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug's approval.

To illustrate how regulators are subject to political pressure, which companies much recognize and consider when making business decisions.

With expenditures totaling $227 billion in 2007, prescription drug purchases are a growing portion of the total medical expenditure, and as this industry continues to grow, prescription drugs will continue to be a critical part of the larger health care industry. This chapter presents a survey on the economics of the US pharmaceutical industry, with a focus on the role of R&D and marketing, the determinants (and complications) of prescription drug pricing, and various aspects of consumer behavior specific to this industry, such as prescription drug regulation, the patient's interaction with the physician, and insurance coverage. This chapter also provides background in areas not often considered in the economics literature, such as the role of pharmacy benefit managers in prescription drug prices and the differentiation between alternative measures of prescription drug prices.

Researchers continue to seek understanding of industrialization as a state managed process. How to create and implement new industries based on advanced knowledge is on the policy agenda of many advanced nations. Measures that promote these developments include national capacity building in science and technology, the formation of technology transfer systems, and the establishment of industrial clusters. What these templates often overlook is an analysis of use. This chapter aims to increase the understanding of the processes that embed new solutions in structures from an industrial network perspective. The chapter describes an empirical study of high-technology industrialization in Taiwan that the researcher conducts to this end. The study shows that the Taiwanese industrial model is oversimplified and omits several important factors in the development of new industries. This study bases its findings on the notions that resource combination occurs in different time and space, the new always builds on existing resource structures, and the users are important as active participants in development processes.

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.

In prior articles in both volume 8 (number 4) and volume 10 (numbers 3/4) of Collection Building, bibliographies of U.S. government publications on AIDS were covered. The first bibliography covered both executive branch and legislative branch materials from 1981 to September 1986. The second bibliography covered only legis‐lative materials from 1986 to 1989. This article complements the second bibliography in its coverage of executive branch materials from 1986 to 1989 and also updates the first work. While 1986 to 1989 is the framework, some items inadvertently omitted from the earlier work are included here.

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.

We are in the midst of a broad societal change in which women’s sexual problems are becoming increasingly medicalized, characterized as treatable medical conditions and defined and understood as a largely physiologically based disease, called “female sexual dysfunction” (FSD). When a condition is medicalized, a medical framework is used to understand it, and medical interventions are used to treat it. As part of this process, then, over the last several years, researchers and pharmaceutical companies have turned attention to developing medical treatments for FSD. As this medicalization continues to unfold with potentially important impacts, it is crucial that we understand the forces working to shape it.

This paper empirically investigates the profit impact of externally sourcing technology through acquisition. Specifically, it questions whether biopharmaceutical acquirers benefit from taking over technologies which are pre-marketed more than those that have already been approved for market. This paper utilizes the resource-based view to determine that the decision depends on the relative value chains of the acquirer and target. We assert that companies with lower research and development (R&D) intensity than their targets benefit from acquisitions of pre-marketed drugs more than they would with marketed drugs because of a complementary combination of competitive assets. Estimations from the U.S. biopharmaceutical sector in the 1990s show that acquirers that take over pre-marketed drugs from targets with higher R&D intensity than themselves have post-acquisition returns between 2% and 11% higher than if they took over marketed drugs.