Rx For Generic Drug Safety

Author : Katherine Eban
Publisher : HarperCollins
Page : 512 pages
File Size : 42,6 Mb
Release : 2020-06-23
Category : Medical
ISBN : 9780063054103

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Bottle of Lies by Katherine Eban Pdf

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Publisher : National Academies Press
Page : 235 pages
File Size : 51,6 Mb
Release : 2018-03-01
Category : Medical
ISBN : 9780309468084

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Making Medicines Affordable by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies Pdf

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Author : Donald O. Beers,Kurt R. Karst
Publisher : Wolters Kluwer
Page : 2154 pages
File Size : 43,7 Mb
Release : 2013-05-22
Category : Law
ISBN : 9781454836094

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Generic and Innovator Drugs by Donald O. Beers,Kurt R. Karst Pdf

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.

Author : Michelle Meadows
Publisher : Unknown
Page : 8 pages
File Size : 43,7 Mb
Release : 2003
Category : Drugs
ISBN : IND:30000037095860

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Greater Access to Generic Drugs by Michelle Meadows Pdf

Author : United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests
Publisher : Unknown
Page : 250 pages
File Size : 44,6 Mb
Release : 1990
Category : Aged
ISBN : UOM:39015043409815

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Rx for Generic Drug Safety by United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests Pdf

Author : Robin A. Cohen,Maria A. Villarroel
Publisher : Unknown
Page : 12 pages
File Size : 48,8 Mb
Release : 2015
Category : Drug utilization
ISBN : UCR:31210024123687

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Strategies Used by Adults to Reduce Their Prescription Drug Costs by Robin A. Cohen,Maria A. Villarroel Pdf

Author : United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests
Publisher : Unknown
Page : 248 pages
File Size : 51,6 Mb
Release : 1990
Category : Aged
ISBN : PSU:000017170796

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Rx for Generic Drug Safety by United States. Congress. House. Select Committee on Aging. Subcommittee on Housing and Consumer Interests Pdf

Author : Eunjoo Pacifici,Susan Bain
Publisher : Academic Press
Page : 280 pages
File Size : 43,7 Mb
Release : 2018-06-13
Category : Medical
ISBN : 9780128111567

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An Overview of FDA Regulated Products by Eunjoo Pacifici,Susan Bain Pdf

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Author : Anonim
Publisher : Unknown
Page : 336 pages
File Size : 53,8 Mb
Release : 1984
Category : Drugs
ISBN : UOM:39015072931507

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Approved Prescription Drug Products with Therapeutic Equivalence Evaluations by Anonim Pdf

Accompanied by supplements.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 46,8 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570

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Pain Management and the Opioid Epidemic by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse Pdf

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author : Lawrence X. Yu,Bing V. Li
Publisher : Springer
Page : 465 pages
File Size : 42,5 Mb
Release : 2014-09-05
Category : Medical
ISBN : 9781493912520

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FDA Bioequivalence Standards by Lawrence X. Yu,Bing V. Li Pdf

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Author : Katherine Eban
Publisher : Unknown
Page : 0 pages
File Size : 47,9 Mb
Release : 2019-07
Category : Drug adulteration
ISBN : 9353450446

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Bottles of Lies by Katherine Eban Pdf

"Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban's Bottle of Lies exposes the deceit behind generic-drug manufacturing--and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings?"--Dust jacket.

Author : Anonim
Publisher : DIANE Publishing
Page : 129 pages
File Size : 43,7 Mb
Release : 2002
Category : Electronic
ISBN : 9781428951938

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Generic drug entry prior to patent expiration an FTC study by Anonim Pdf

Author : Rosemary Gibson,Janardan Prasad Singh
Publisher : Prometheus Books
Page : 306 pages
File Size : 45,6 Mb
Release : 2018-04-17
Category : Political Science
ISBN : 9781633883826

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China Rx by Rosemary Gibson,Janardan Prasad Singh Pdf

Millions of Americans are taking prescription drugs made in China and don't know it--and pharmaceutical companies are not eager to tell them. This is a disturbing, well-researched wake-up call for improving the current system of drug supply and manufacturing. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This probing book examines the implications of our reliance on China on the quality and availability of vital medicines.

Author : Anonim
Publisher : Unknown
Page : 144 pages
File Size : 55,7 Mb
Release : 1998
Category : Veterinary drugs
ISBN : UOM:39015035689275

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FDA Approved Animal Drug Products by Anonim Pdf