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Compassionate Use and Emergency Use Authorization for Unapproved Drugs

Author: Tonya Burke

Publisher:

Published: 2015

Total Pages: 113

ISBN-13: 9781634841405

The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorization. This book examines FDA policies on compassionate use and emergency use authorizations. It also describes how drugs are approved and come to market, including FDA's role in that process, and discusses FDA and industry roles once drugs are on the pharmacy shelves. Finally, this book describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary; presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children, and provides an overall understanding of FDA's authority to ensure that drugs prescribed to children are safe and effective.

Access to Unapproved Drugs

Author: Thaul Susan

Publisher:

Published: 2015

Total Pages:

ISBN-13:

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This report discuses the approval or licensure procedures of drugs and biological products which Food and Drug Administration (FDA) may permit the sponsor to provide an unapproved or unlicensed product to patients outside the standard regulatory framework.

Guidance

Author:

Publisher:

Published: 2007

Total Pages:

ISBN-13:

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This guidance explains FDA's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).2 Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The Emergency Use Authorization (EUA) authority recently granted by Congress allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives. The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met.

Nightmare Scenario

Author: Yasmeen Abutaleb

Publisher: HarperCollins

Published: 2022-07-05

Total Pages: 496

ISBN-13: 006327308X

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Instant #1 New York Times and Wall Street Journal bestseller From the Washington Post journalists Yasmeen Abutaleb and Damian Paletta—the definitive account of the Trump administration’s tragic mismanagement of the COVID-19 pandemic, and the chaos, incompetence, and craven politicization that has led to more than a half million American deaths and counting. Since the day Donald Trump was elected, his critics warned that an unexpected crisis would test the former reality-television host—and they predicted that the president would prove unable to meet the moment. In 2020, that crisis came to pass, with the outcomes more devastating and consequential than anyone dared to imagine. Nightmare Scenario is the complete story of Donald Trump’s handling—and mishandling—of the COVID-19 catastrophe, during the period of January 2020 up to Election Day that year. Yasmeen Abutaleb and Damian Paletta take us deep inside the White House, from the Situation Room to the Oval Office, to show how the members of the administration launched an all-out war against the health agencies, doctors, and scientific communities, all in their futile attempts to wish away the worst global pandemic in a century. From the initial discovery of this new coronavirus, President Trump refused to take responsibility, disputed the recommendations of his own pandemic task force, claimed the virus would “just disappear,” mocked advocates for safe-health practices, and encouraged his base and the entire GOP to ignore or rescind public health safety measures. Abutaleb and Paletta reveal the numerous times officials tried to dissuade Trump from following his worst impulses as he defied recommendations from the experts and even members of his own administration. And they show how the petty backstabbing and rivalries among cabinet members, staff, and aides created a toxic environment of blame, sycophancy, and political pressure that did profound damage to the public health institutions that Americans needed the most during this time. Even after an outbreak in the fall that swept through the White House and infected Trump himself, he remained defiant in his approach to the virus, very likely costing him his own reelection. Based on exhaustive reporting and hundreds of hours of interviews from inside the disaster zone at all levels of authority, Nightmare Scenario is a riveting account of how the United States government failed its people as never before, a tragedy whose devastating aftershocks will linger and be felt by generations to come.

Guidance for Managing Ethical Issues in Infectious Disease Outbreaks

Author: World Health Organization

Publisher:

Published: 2016

Total Pages: 0

ISBN-13: 9789241549837

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"Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.

Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine

Author: National Academies Of Sciences Engineeri

Publisher: National Academies Press

Published: 2022-07-20

Total Pages:

ISBN-13: 9780309269452

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The National Strategy for Combating Antibiotic Resistant Bacteria, published in 2014, sets out a plan for government work to mitigate the emergence and spread of resistant bacteria. Direction on the implementation of this strategy is provided in five-year national action plans, the first covering 2015 to 2020, and the second covering 2020 to 2025. Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine evaluates progress made against the national strategy. This report discusses ways to improve detection of resistant infections and estimate the risk to human health from environmental sources of resistance. In addition, the report considers the effect of agricultural practices on human and animal health and animal welfare and ways these practices could be improved, and advises on key drugs and diseases for which animal-specific test breakpoints are needed.

Pediatric Sedation Outside of the Operating Room

Author: Keira P. Mason

Publisher: Springer

Published: 2014-10-11

Total Pages: 749

ISBN-13: 1493913905

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This is a major revision, updating, and expansion of the leading single-source volume on pediatric sedation outside of the operating room. Edited and written by an international roster of outstanding experts, it is the only book aimed at the broad range of specialists who deliver pediatric sedation in the non-OR setting. The Second Edition features a significant expansion of contributions from international leaders and individual new chapters on pre-sedation assessment; sedatives’ short- and long-term effects on neurocognition; non-pharmacologic distractions; Michael Jackson’s death and medical ethics; the role of simulation in safety and training; and palliative sedation in terminally ill children. The specialty-specific chapters continue to be geared toward all sedation providers, regardless of where they practice and patient safety is again emphasized. Fundamental chapters provide in-depth reviews of topics which include, among others, physiology and pharmacology. The book presents the latest guidelines across the specialties, both in the United States and abroad and noteworthy, ongoing research endeavors. From reviews of the First Edition: “This meritorious volume is a splendid collection of materials from highly experienced authors...I will make extensive use of this reference as the academic medical center in which I work continues to build sedation practices and assess credentialing/privileging aspects for professionals of all fields.” —Joseph R. Tobin, MD in Journal of the American Medical Association. “Brings together sedation practice from a broad range of specialties into one well-written pediatric text...I will certainly be using this book as a reference text in the future.” — Pediatric Anesthesia. “The first [text] directed at all specialists that treat children who require some sedation...also recognizes the contributions to pediatric sedation of many international societies and governmental organizations...It should be on the shelves of all office-based practices.” —Journal of Neurosurgical Anesthesiology. "With the ever-increasing opportunities to perform various investigations and therapeutic procedures, combined with increasing demands and expectations from children and their parents, the need and demand for safe and effective sedation of paediatric patients outside the operating room is increasing. Against this background, the second edition of ‘Pediatric Sedation Outside the Operating Room’ is a very timely addition to the anaesthesia literature."—British Journal of Anesthesia

Addressing the Barriers to Pediatric Drug Development

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-08-12

Total Pages: 64

ISBN-13: 0309178657

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Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

A National Cancer Clinical Trials System for the 21st Century

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-07-08

Total Pages: 317

ISBN-13: 0309157870

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The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Practical Aspects of Signal Detection in Pharmacovigilance

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: Cioms

Published: 2010

Total Pages: 0

ISBN-13: 9789290360827

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In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.