Generic drug entry prior to patent expiration an FTC study
Author :
Publisher : DIANE Publishing
Page : 129 pages
File Size : 30,53 MB
Release : 2002
Category :
ISBN : 1428951938
Author :
Publisher : DIANE Publishing
Page : 129 pages
File Size : 30,53 MB
Release : 2002
Category :
ISBN : 1428951938
Author : United States. Federal Trade Commission
Publisher : William s Hein & Company
Page : 113 pages
File Size : 16,56 MB
Release : 2002-01-01
Category : Law
ISBN : 9781575887456
"In April 2001, the Commission began an industry-wide study focused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study's purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established: generic entry prior to expiration of the brand-name company's patents on the relevant drug product. This report sets forth the results of the study. The study was prompted, in part, by the Commission's enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions. The study was designed to determine whether such agreements are isolated instances or more typical, and whether particular provisions of the Hatch-Waxman Amendments are susceptible to strategies to delay or deter consumer access to low-cost generic alternatives to brand-name drug products." -- from the Introduction, p. 1.
Author : United States. Federal Trade Commission
Publisher :
Page : pages
File Size : 16,83 MB
Release : 2002
Category : Drugs
ISBN :
In April 2001, the Commission began an industry-wide study focused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study's purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established: generic entry prior to expiration of the brand-name company's patents on the relevant drug product.
Author : United States. Federal Trade Commission
Publisher :
Page : 136 pages
File Size : 47,48 MB
Release : 2002
Category : Drugs
ISBN :
Author : Robin Feldman
Publisher : Cambridge University Press
Page : 165 pages
File Size : 22,80 MB
Release : 2017-06-09
Category : Law
ISBN : 131673949X
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 235 pages
File Size : 37,77 MB
Release : 2018-03-01
Category : Medical
ISBN : 0309468086
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 : Michael Kremer
Publisher :
Page : 56 pages
File Size : 21,5 MB
Release : 1996
Category :
ISBN :
Author : Herbert HOVENKAMP
Publisher : Harvard University Press
Page : 392 pages
File Size : 12,96 MB
Release : 2009-06-30
Category : Law
ISBN : 9780674038820
After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Author : B. Rajesh Kumar
Publisher : Springer
Page : 341 pages
File Size : 44,87 MB
Release : 2018-11-29
Category : Business & Economics
ISBN : 303002363X
This book highlights research-based case studies in order to analyze the wealth created in the world’s largest mergers and acquisitions (M&A). This book encourages cross fertilization in theory building and applied research by examining the links between M&A and wealth creation. Each chapter covers a specific case and offers a focused clinical examination of the entire lifecycle of M&A for each mega deal, exploring all aspects of the process. The success of M&A are analyzed through two main research approaches: event studies and financial performance analyses. The event studies examine the abnormal returns to the shareholders in the period surrounding the merger announcement. The financial performance studies examine the reported financial results of acquirers before and after the acquisition to see whether financial performance has improved after merger. The relation between method of payment, premium paid and stock returns are examined. The chapters also discuss synergies of the deal-cost and revenue synergies. Mergers and acquisitions represent a major force in modern financial and economic environment. Whether in times of boom or bust, M&As have emerged as a compelling strategy for growth. The biggest companies of modern day have all taken form through a series of restructuring activities like multiple mergers. Acquisitions continue to remain as the quickest route companies take to operate in new markets and to add new capabilities and resources. The cases covered in this book highlights high profile M&As and focuses on the wealth creation for shareholders of acquirer and target firms as a financial assessment of the merger’s success. The book should be useful for finance professionals, corporate planners, strategists, and managers.
Author : Joseph M. Kizza
Publisher : Springer Science & Business Media
Page : 375 pages
File Size : 33,59 MB
Release : 2007-06-02
Category : Computers
ISBN : 0387224661
This textbook provides an introduction to the social and policy issues which have arisen as a result of information technology. Whilst it assumes a modest familiarity with computers, its aim is to provide a guide to the issues suitable for undergraduates. In doing so, the author prompts the students to consider questions such as: "What are the moral codes of cyberspace?" Throughout, the book shows how in many ways the technological development is outpacing the ability of our legal systems to keep up, and how different paradigms applied to ethical questions may often offer conflicting conclusions. As a result students will find this to be a thought-provoking and valuable survey.