The Challenges of Regulating Drugs and New Technologies
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
Category: Business & Economics
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.
Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
Healthcare and Biotechnology in the 21st Century: Concepts and Case Studies introduces students not pursuing degrees in science or engineering to the remarkable new applications of technology now available to physicians and their patients and discusses how these technologies are evolving to permit new treatments and procedures. The book also elucidates the societal and ethical impacts of advances in medical technology, such as extending life and end of life decisions, the role of genetic testing, confidentiality, costs of health care delivery, scrutiny of scientific claims, and provides background on the engineering approach in healthcare and the scientific method as a guiding principle. This concise, highly relevant text enables faculty to offer a substantive course for students from non-scientific backgrounds that will empower them to make more informed decisions about their healthcare by significantly enhancing their understanding of these technological advancements.
Opioid Therapy in the 21st Century, Second Edition provides clinicians with up-to-date, evidence-based information about appropriate opioid use, including the potential benefits and adverse affects of the therapy.
The U.S. Department of Health and Human Services (HHS) profoundly affects the lives of all Americans. Its agencies and programs protect against domestic and global health threats, assure the safety of food and drugs, advance the science of preventing and conquering disease, provide safeguards for America's vulnerable populations, and improve health for everyone. However, the department faces serious and complex obstacles, chief among them rising health care costs and a broadening range of health challenges. Over time, additional responsibilities have been layered onto the department, and other responsibilities removed, often without corresponding shifts in positions, procedures, structures, and resources. At the request of the U.S. House of Representatives Committee on Oversight and Government Reform, HHS in the 21st Century assesses whether HHS is "ideally organized" to meet the enduring and emerging health challenges facing our nation. The committee identifies many factors that affect the department's ability to address its range of responsibilities, including divergence in the missions and goals of the department's agencies, limited flexibility in spending, impending workforce shortages, difficulty in retaining skilled professionals, and challenges in effectively partnering with the private sector.
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.