Role Of Food And Drug Administration Research Articles

Generic Drugs in the United States: Policies to Address Pricing and Competition.

The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter the market, but the past decade has witnessed rising costs and shortages of generic drugs. We describe the strategies used by brand-name manufacturers to undermine generic competition and the reasons underlying the price increases of off-patent drugs, some of which continue to lack any competition from generic versions, and others that have increased in price despite having generic versions. We discuss the FDA's role in addressing drug prices and promoting competition, including recent agency policies to modify its process of reviewing generic drug applications and to prioritize applications for off-patent drugs with few competitors. We also examine proposed policy solutions and research areas that could help address the price increases of off-patent drugs.

Public Knowledge and Credibility Perceptions of the FDA as a Tobacco Regulator.

Since the U.S. Food and Drug Administration (FDA) was granted regulatory authority over tobacco products in 2009, few studies have examined perceived credibility of the FDA in this role. The current study assessed knowledge and credibility of the FDA as a regulator of tobacco products. In a nationally representative survey of U.S. adults (N = 4758), we assessed knowledge that the FDA regulates the manufacture, distribution, and marketing of cigarettes, and credibility of the FDA as a tobacco regulator. We examined demographic differences in knowledge and credibility, and associations of knowledge and trust in government with credibility perceptions. Less than half of respondents reported knowing the FDA regulates how cigarettes are sold (46.8%) and advertised (49.7%), and only 36.0% knew the FDA regulates how cigarettes are made, with few demographic differences. Respondents reported that the FDA was moderately credible in regulating tobacco. Knowledge of the FDA as a tobacco regulator and trust in government were the strongest predictors of credibility. Being of younger age, being White (compared to African American), and being male were associated with higher credibility ratings of the FDA. Much of the public still does not know that the FDA regulates tobacco products, and credibility perceptions are moderate. Greater knowledge of the FDA's regulatory role was associated with higher credibility; efforts that increase the public's understanding of the FDA's role as a tobacco regulator may positively impact views of the agency's credibility. This may in turn improve public reception to the FDA's messages and regulations. This study is the first to show nationally representative estimates of both knowledge and credibility of the FDA as a tobacco regulator. Our research shows further that knowledge of the FDA's tobacco regulatory roles is likely to be an important factor related to perceived credibility of the FDA. Increasing the public's knowledge of the FDA's roles may enhance the agency's credibility, which can improve public reception to messages and regulations.

Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.

The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of patients receiving investigational drugs under expanded access. To better define FDA's role in the review of requests for expanded access, multiple queries of FDA's Center for Drug Evaluation and Research (CDER) document tracking system were performed. The queries identified reasons for, and outcomes of, expanded access requests for investigational drugs that were either not allowed to proceed or denied over a 10-year time period. An in-depth review of a random sample of single-patient, non-emergency investigational new drug (IND) applications that were allowed to proceed was also conducted. Overall, 99.3% of the applications for almost 9000 expanded access of an investigational drug were allowed to proceed. There were 62 requests that were either denied (38 emergency INDs) or not allowed to proceed (24 non-emergency INDs). The most common reasons for denying emergency INDs was that the patient was stable on current therapy and that it was not deemed an emergency. The most common reasons for not allowing non-emergency expanded access INDs to proceed were incomplete application, unsafe dosing, demonstrated lack of efficacy for intended use, availability of adequate alternative therapies, and inadequate information provided in the application on which to base a decision. A review of a random sample of 150 single-patient, non-emergency INDs revealed that FDA recommended changes to dosing, safety monitoring, or informed consent in 11%. FDA plays a significant role in the protection of patients who receive investigational drugs under expanded access. An extremely small percentage of applications received are not allowed to proceed; however, FDA provides significant input based on information that may not be available to treating physicians in order to ensure patient safety under the applications that do proceed.

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future.

In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it showcased FDA's global role in drug development, approval, and access. FDA's response to EVD highlights the panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework. This paper evaluates the strengths and weaknesses of FDA's response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats. In particular, it argues that greater emphasis should be placed on drug development in interoutbreak periods and on assuring access to approved products. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response.

Electronic cigarettes: gateway to understanding the FDA?

Electronic cigarettes: gateway to understanding the FDA?

The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role

The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

Anti-Obesity Agents and the US Food and Drug Administration.

Despite the growing market for obesity care, the US Food and Drug Administration (FDA) has approved only two new pharmaceutical agents-lorcaserin and combination phentermine/topiramate-for weight reduction since 2000, while removing three agents from the market in the same time period. This article explores the FDA's history and role in the approval of anti-obesity medications within the context of a public health model of obesity. Through the review of obesity literature and FDA approval documents, we identified two major barriers preventing fair evaluation of anti-obesity agents including: (1) methodological pitfalls in clinical trials and (2) misaligned values in the assessment of anti-obesity agents. Specific recommendations include the use of adaptive (Bayesian) design protocols, value-based analyses of risks and benefits, and regulatory guidance based on a comprehensive, multi-platform obesity disease model. Positively addressing barriers in the FDA approval process of anti-obesity agents may have many beneficial effects within an obesity disease model.

TCORS set to support the FDA's regulatory role: Program designed to generate tobacco‐related research to inform policy

TCORS set to support the FDA's regulatory role: Program designed to generate tobacco‐related research to inform policy

Agency Perspectives on Food Safety for the Products of Animal Biotechnology

Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals.

Drug development in inflammatory bowel disease: The role of the FDA

All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.

Arthur Daemmrich and Joanna Radin (eds), Perspectives on risk and regulation: the FDA at 100, Philadelphia, Chemical Heritage Foundation, 2007, pp. xvii, 163, $12.00 (paperback 978-0-941901-41-0).

This collection of short essays is derived from a conference at the Chemical Heritage Foundation in Philadelphia in May 2006 to mark the centenary of the US Food and Drug Administration (FDA). The editors, senior research fellow and research fellow respectively at the Chemical Heritage Foundation, bring together FDA officials, including nutritional scientists, and industry scientists, in what is styled as a collaborative enterprise between regulator and business. This is perhaps designed to emphasize the FDA's role in partnering rather than simply policing business activity. Some important industry figures are here: the global nutrition director of Heinz; the vice-president of regulatory affairs at Johnson and Johnson; the senior vice-president and chief medical officer for GlaxoSmithKline; and the volume closes with comments from Andrew C von Eschenbach, the current (and twentieth) FDA commissioner. These and five of the book's other contributors concentrate essentially on current concerns in the regulation of food, food supplements, drugs and medical devices. Some interesting insights are offered, chiefly relating to the apparently accelerating nature of advances in scientific and medical knowledge, but generally there is a limited engagement with scientific and indeed social scientific debates, especially in relation to the key issues of risk and regulation which are flagged in the book's title. Surprisingly too, perhaps, given the centenary that is being marked, there is relatively little historical insight. The editors provide a short introduction, subtitled ‘Historical and contemporary perspectives’, which glides over the former in a single paragraph (p. 4). Peter Barton Hutt, a Washington lawyer and former chief counsel for the FDA, then provides a discussion of ten ‘Turning points in FDA history’. This is useful, drawing attention to the very wide range of the organization's remit and responsibilities over the course of its first century, but in this slightly truncated “highlights package” form it does not really do justice to the FDA's highly contested origins and early decades. The 1906 Food and Drugs and Meat Inspection Acts provided improved consumer protection but offered a blanket to business also, legitimizing the methods of food and pharmaceutical producers. The meat packers, who were arguably the worst offenders against food consumers, and whose practices were vividly exposed in Upton Sinclair's socialist novel, The jungle (1906), were also excused from the burden of funding the inspection and regulation regime. This was borne instead, to the producers’ satisfaction, by the Federal government. This important tale also highlights the fact that global food security has deep historical roots. The jungle precipitated a crisis in the export market for US meat products, and this in large part accelerated the drive towards Federal regulation. Yet elsewhere in the volume the current director of the FDA Center for Food Safety and Applied Nutrition, making otherwise sensible observations about the problems of food security in the contemporary globalized market, seeks to present the issue as very largely an unprecedented phenomenon, which clearly it is not. Difficult issues and problems, it should be emphasized, are not ignored in the book. There are references to the absence in the US of a comprehensive system of national health care, which is not unrelated to the activities of pharmaceutical companies, and the still contested nature of the FDA is alluded to, with the struggle to secure continued Federal funding leading the organization into the problematic practice of charging user fees for new drugs and medical devices. These lively and ongoing concerns are well presented in the book, which would—it bears repeating—have been considerably strengthened with more robust and extensive historical perspective.

ASM Comments on the FDA Science Board Report

ASM concurs with the highly disturbing conclusions of the Food and Drug Administration (FDA) Science Board Report to assess whether FDA science and technology can support current and future regulatory needs. For years, ASM and other scientific and health organizations have been warning of deteriorating scientific research, infrastructure, and personnel resources for the FDA, which is responsible for regulating approximately $1 trillion in consumer products annually. In just the past year, publicized discoveries of contaminated products from toys to pet food have reminded us of the FDA's critical role in safeguarding public health. As the study report emphatically states, the nation is at risk if FDA science is at risk.

Ensuring that consumers receive appropriate information from drug ads: what is the FDA's role?

The promise of direct-to-consumer (DTC) prescription drug advertisements lies in their potential to educate consumers about medical conditions and the possibility of treatment. But this promise can only be fulfilled if consumers are given clear and accurate information. The responsibility for ensuring that this occurs falls on the Food and Drug Administration (FDA). Recent congressional investigations have indicated that the agency is failing at this task, as FDA enforcement actions against false and misleading ads have declined precipitously in recent years. Other FDA efforts, such as its recently released guidelines on prescription drugs, do not appear to be helpful, potentially confusing consumers more than helping them.

The FDA's Regulatory Role in the ICCVAM Process

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a permanent body set forth in the ICCVAM Authorization Act of 2000 (Public Law 106-545), is charged with establishing criteria and processes for the validation and regulatory acceptance of toxicological test methods of interest to Federal agencies, including alternative methods that reduce, refine, or replace the use of animals for research and testing purposes. In response to that mandate, 15 Federal regulatory and research agencies and programmes that would consider utilising such methods or the results derived from them, now participate in cross-agency efforts directed toward the identification, standardisation, validation, acceptance, regulatory implementation and international harmonisation and adoption of such test methods. As an integral member of ICCVAM since its inception, the US Food and Drug Administration (FDA) has established processes for responding to ICCVAM issues and recommendations. The participating FDA units include all FDA research and product-based centres and oversight offices. FDA product centres respond to distinct regulatory mandates and regulate different products. Upon completion of a validation effort, ICCVAM forwards its recommendations to member Government agencies regarding the validity and technical acceptability of a method. The FDA's response consists of the conclusions reached by each of its regulatory components and addresses such factors as their concurrence with ICCVAM's conclusions, the practical applicability of the method to the products they regulate and the feasibility of implementation of an accepted method to supplement or supplant those currently used. Each centre/office independently determines which of the ICCVAM-recommended tests are appropriate for implementation to satisfy its regulatory obligations to ensure product safety and to protect human health. The adoption of a method triggers a notification process to announce the availability and utility of a method, encourage its use, and inform, educate and train end-users and regulatory review staff.

FDA's role in anesthetic drug development.

FDA's role in anesthetic drug development.

Safe and Effective Medical Devices–Everyoneʼs Responsibility

Health care professionals frequently ask questions about how medical devices reach the market. These questions stem partly from their concerns about the "lengthiness" of the process. Because there appear to be some misconceptions about the process as required by law, nurses and physicians may find it useful to understand how the Food and Drug Administration (FDA) enforces its laws, how it works with user communities to identify trends and problems with medical devices, and how it develops and implements educational programs to complement its enforcement responsibilities. The purpose of this article, therefore, is to explain the FDA's role in regulating medical devices, the responsibilities of manufacturers in complying with the laws which regulate getting safe and effective devices to market, and the role of health care professionals in reporting adverse incidents to the FDA to ensure the safe and effective use of this equipment.