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Options For Safe And Effective Prescription Drug Importation
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Author :United States. Congress. Senate. Committee on Commerce, Science, and Transportation Publisher : ISBN 13 : Total Pages :68 pages Book Rating :4.:/5 (319 download)
Book Synopsis Options for Safe and Effective Prescription Drug Importation by : United States. Congress. Senate. Committee on Commerce, Science, and Transportation
Download or read book Options for Safe and Effective Prescription Drug Importation written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation and published by . This book was released on 2012 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Commerce, Science, and Transportation Publisher : ISBN 13 : Total Pages : pages Book Rating :4.:/5 (124 download)
Book Synopsis Options for Safe and Effective Prescription Drug Importation :. by : United States. Congress. Senate. Committee on Commerce, Science, and Transportation
Download or read book Options for Safe and Effective Prescription Drug Importation :. written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation and published by . This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Importing Prescription Drugs written by and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Can purchases from abroad lower the cost of prescription drugs to U.S. consumers? Current law allows pharmacists and wholesalers to import prescription drugs from Canada commercially, and codifies the Food and Drug Administration's (FDA) current practice of allowing imports of prescription drugs by individuals under certain defined circumstances. There is, however, one proviso. The Secretary of Health and Human Services (HHS) must first certify that the drugs to be imported under the program would "pose no additional risk to the public's health and safety; and result in a significant reduction in the cost of covered products to the American consumer" -- a step no Secretary has been willing to take. FDA has argued that with the likely exponential increase in imports -- right now it tolerates some imports for personal use -- it is impossible to monitor and guarantee that these drugs would be safe. Meanwhile, some states and municipalities, looking at ways to control their expenditures for prescription drugs, have created websites to direct U.S. consumers to Canadian sources; and several state Governors have proposed pilot import programs. This issue is addressed in elements of three pairs of pending bills: S. 109 (introduced by Senator Vitter) and H.R. 328 (introduced by Representative Gutknecht); S. 184 (introduced by Senator Gregg) and H.R. 753 (introduced by Representative Bradley); and S. 334 (introduced by Senator Dorgan) and H.R. 700 (introduced by Representative Emerson). All would allow commercial and personaluse imports and replace the need for HHS Secretary certification with different ways to assure safety and effectiveness, among them requiring tamper-resistant and anticounterfeit packaging; inspecting samples of imported drugs; requiring registration of importers, exporters, and Internet pharmacies; and enforcing extensive chain-ofcustody monitoring and documentation. They also present different approaches for influencing industry response. Opponents of the legislation raise concerns about safety, added costs, the feasibility of imports as a long-term solution to high domestic prices, and whether, beyond the short term, U.S. consumers would pay less for their prescription drugs. Other points of contention include issues of patent law and international trade agreements. The report examines these issues, spells out how they are treated from bill to bill, and refers to alternatives to importation to ease the burden of prescription drug costs on consumers: use of generics and disease management techniques; research and development incentives to industry; studying the drugs' comparative effectiveness and then judiciously applying the findings in benefit package and prescribing decisions; and assuming some of the consumers' cost.
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :68 pages Book Rating :4.F/5 ( download)
Book Synopsis Drug Importation by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Drug Importation written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2005 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug Importation and Internet Sales by :
Download or read book Prescription Drug Importation and Internet Sales written by and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: As prescription drug prices have escalated in recent years, so too has consumer interest in purchasing less costly medications abroad. Meanwhile, during the 108th Congress, the House of Representatives passed a bill that would allow wholesalers, pharmacists, and consumers to import certain prescription drugs from 25 different countries, including Canada, where drug prices are often lower than in the United States. Although the bill passed the House, the provisions allowing drug importation faced opposition in the Senate and were not included in the conference agreement on Medicare prescription drug benefits. Instead, the final Medicare bill modified a provision of existing law that authorizes the Food and Drug Administration (FDA) to allow the importation of prescription drugs if the Secretary of Health and Human Services certifies that implementing such a program is safe and reduces costs, a determination that no Secretary has made in the years since a similar certification requirement was established in 2000. Despite the compromise reached in the final Medicare bill, the debate about drug importation continues. On the one hand, some policymakers remain opposed to allowing prescription drugs to be imported from foreign countries, arguing that the FDA cannot guarantee the safety of such drugs. On the other hand, importation proponents, who claim that importation would result in significantly lower prices for U.S. consumers, say that safety concerns are overblown and would recede if additional precautions were implemented. Just as the FDA has expressed concerns about the safety of imported drugs, federal regulators have become increasingly worried about the risks posed by some online pharmacies and Internet drug sales. Indeed, the regulation of prescription drug importation and the oversight of online pharmacies often overlap because many consumers use online pharmacies to purchase imported drugs. Regardless of whether or not drugs purchased online are imported, the FDA is worried about the safety of such medications because of its concern that a small number of online doctors and pharmacies are exploiting regulatory gaps to prescribe and dispense illegal, addictive, or unsafe drugs. In response to concerns about prescription drug imports and Internet sales, lawmakers have introduced the following bills during the 109th Congress: H.R. 328, H.R. 563, H.R. 578, H.R. 700, H.R. 753, H.R. 840, S. 109, S. 184, S. 334, and S. 399. Currently, the following federal and state agencies are involved in regulating aspects of prescription drug importation and Internet sales: the Food and Drug Administration, the U.S. Customs and Border Protection (CBP), the Drug Enforcement Agency (DEA), state boards of pharmacy, and state medical boards. Although this report is intended to focus on legal aspects of prescription drug importation and Internet sales, both legal and policy issues are addressed because they are closely linked. For a more complete analysis of policy issues, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Book Synopsis Importing Into the United States by : U. S. Customs and Border Protection
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Cancer Pain Management by : Deborah B. McGuire
Download or read book Cancer Pain Management written by Deborah B. McGuire and published by Jones & Bartlett Learning. This book was released on 1995 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer Pain Management, Second Edition will substantially advance pain education. The unique combination of authors -- an educator, a leading practitioner and administrator, and a research scientist -- provides comprehensive, authoritative coverage in addressing this important aspect of cancer care. The contributors, acknowledged experts in their areas, address a wide scope of issues. Educating health care providers to better assess and manage pain and improve patientsrsquo; and familiesrsquo; coping strategies are primary goals of this book. Developing research-based clinical guidelines and increasing funding for research is also covered. Ethical issues surrounding pain management and health policy implications are also explored.
Book Synopsis Disease Control Priorities in Developing Countries by : Dean T. Jamison
Download or read book Disease Control Priorities in Developing Countries written by Dean T. Jamison and published by World Bank Publications. This book was released on 2006-04-02 with total page 1449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309486483 Total Pages :175 pages Book Rating :4.3/5 (94 download)
Book Synopsis Medications for Opioid Use Disorder Save Lives by : National Academies of Sciences, Engineering, and Medicine
Download or read book Medications for Opioid Use Disorder Save Lives written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-16 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already existâ€"like evidence-based medicationsâ€"are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :Centers for Disease Control and Prevention CDC Publisher :Oxford University Press ISBN 13 :0190628634 Total Pages :705 pages Book Rating :4.1/5 (96 download)
Book Synopsis CDC Yellow Book 2018: Health Information for International Travel by : Centers for Disease Control and Prevention CDC
Download or read book CDC Yellow Book 2018: Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Book Synopsis Intellectual Property Rights and International Trade by : Shayerah Ilias
Download or read book Intellectual Property Rights and International Trade written by Shayerah Ilias and published by Nova Publishers. This book was released on 2008 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Intellectual property rights basics -- Global intellectual property holdings -- Contribution of intellectual property to U.S. economy -- The organized structure of IPR protection -- U.S. trade law -- Issues for Congress.
