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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 160
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Book Description
The purpose of this study is to assess the current means of regulating drug advertising to health professionals and to consumers, and to recommend changes (where appropriate) that will not adversely affect the current level of consumer protection. After introductory sections outlining the elements of an ideal advertising control system and the issues identified by comparing current control measures with elements of the ideal system, the report examines those issues in light of previous experience in the Drugs Directorate, of Canadian self-regulatory systems, and of control systems used in other jurisdictions. The issues addressed are: misleading advertising; complaints and appeal systems; sanctions; enforcement of remedial measures; post-publication monitoring; print advertising to the consumer; pre-review level of compliance; prescription drug advertising to the consumer; pre-market approval advertising; and foreign advertising. Recommendations are made with regard to clarification of regulatory requirements and policy, increasing regulatory penalties, promoting the self-regulation concept, improvements in self-regulation, and improving information flow.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 160
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Book Description
The purpose of this study is to assess the current means of regulating drug advertising to health professionals and to consumers, and to recommend changes (where appropriate) that will not adversely affect the current level of consumer protection. After introductory sections outlining the elements of an ideal advertising control system and the issues identified by comparing current control measures with elements of the ideal system, the report examines those issues in light of previous experience in the Drugs Directorate, of Canadian self-regulatory systems, and of control systems used in other jurisdictions. The issues addressed are: misleading advertising; complaints and appeal systems; sanctions; enforcement of remedial measures; post-publication monitoring; print advertising to the consumer; pre-review level of compliance; prescription drug advertising to the consumer; pre-market approval advertising; and foreign advertising. Recommendations are made with regard to clarification of regulatory requirements and policy, increasing regulatory penalties, promoting the self-regulation concept, improvements in self-regulation, and improving information flow.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
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:
Publisher:
ISBN:
Category : Electronic journals
Languages : en
Pages : 484
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
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Book Description
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: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103
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Book Description
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Author:
Publisher:
ISBN:
Category : Marketing
Languages : en
Pages : 704
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Book Description
Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages :
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Book Description
The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)
Author: David Pryde
Publisher: Royal Society of Chemistry
ISBN: 1782624201
Category : Science
Languages : en
Pages : 487
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Book Description
Orphan drugs are designated drug substances that are intended to treat rare or ‘orphan’ diseases. More than 7000 rare diseases are known that collectively affect some 6-7% of the developed world’s population; however, individually, any single, rare disease may only affect a handful of people making them commercially unattractive for the biopharmaceutical industry to target. Ground breaking legislation, starting with the Orphan Drug Act that was passed in the US in 1983 to provide financial incentives for companies to develop orphan drugs, has sparked ever increasing interest from biopharmaceutical companies to tackle rare diseases. These developments have made rare diseases, and the orphan drugs that treat them, sufficiently attractive to pharmaceutical development and many pharmaceutical companies now have research units dedicated to this area of research. It is therefore timely to review the area of orphan drugs and some of the basic science, drug discovery and regulatory factors that underpin this important, and growing, area of biomedical research. Written by a combination of academic and industry experts working in the field, this text brings together expert authors in the regulatory, drug development, genetics, biochemistry, patient advocacy group, medicinal chemistry and commercial domains to create a unique and timely reference for all biomedical researchers interested in finding out more about orphan drugs and the rare diseases they treat. Providing an up-to-date monograph, this book covers the basic science, drug discovery and regulatory elements behind orphan drugs and will appeal to medicinal and pharmaceutical chemists, biochemists and anyone working within the fields of rare disease research and drug development or pharmaceuticals in industry or academia.
Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215024572
Category : Political Science
Languages : en
Pages : 556
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Book Description
Incorporating HC 1030-i to iii.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133947
Category : Medical
Languages : en
Pages : 346
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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
