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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection
Publisher : Unknown
Page : 172 pages
File Size : 53,6 Mb
Release : 2007
Category : Law
ISBN : PSU:000065527481
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection
Publisher : Unknown
Page : 328 pages
File Size : 49,7 Mb
Release : 2012
Category : Law
ISBN : MINN:31951D03586254V
Author : Anonim
Publisher : Unknown
Page : 310 pages
File Size : 40,9 Mb
Release : 2009
Category : Electronic
ISBN : UOM:39015084752248
Author : United States. Congress. House. Committee on Energy and Commerce
Publisher : Unknown
Page : 312 pages
File Size : 50,5 Mb
Release : 2009
Category : Electronic
ISBN : UCR:31210022719510
Author : United States. Congress. House. Committee on Energy and Commerce
Publisher : Unknown
Page : 312 pages
File Size : 44,5 Mb
Release : 2009
Category : Energy policy
ISBN : STANFORD:36105050504385
Author : Christopher Scott Hemphill
Publisher : Stanford University
Page : 249 pages
File Size : 53,6 Mb
Release : 2010
Category : Electronic
ISBN : STANFORD:np770mr7521
This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.
Author : Kevin J. Hickey,Kevin T. Richards
Publisher : Unknown
Page : 58 pages
File Size : 48,9 Mb
Release : 2021
Category : Drugs
ISBN : OCLC:1274040129
Author : United States. Congress. House. Committee on Energy and Commerce
Publisher : Unknown
Page : 636 pages
File Size : 46,8 Mb
Release : 2007
Category : Electronic
ISBN : PSU:000066595991
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 : 49,7 Mb
Release : 2018-03-01
Category : Medical
ISBN : 9780309468084
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 : Hugh Hansen
Publisher : Bloomsbury Publishing
Page : 893 pages
File Size : 42,7 Mb
Release : 2008-03-26
Category : Law
ISBN : 9781847314154
Hart Publishing is pleased to announce that it has recently become publisher of this prestigious and much valued work. The 15th Annual volume in the series collects the presentations and discussion from the Annual Fordham IP Conference. The contributions, by leading world experts, analyze the most pressing issues in copyright, trademark and patent law as seen from the perspectives of the USA, the EU, Asia and WIPO. This volume, in common with its predecessors, seeks to make a lasting contribution to discourse in IP law; few of the chapters are merely descriptive, and most raise questions of policy or discuss new developments. Praise for the Fordham International Intellectual Property Conference: "This must be one of the most enjoyable and thought-provoking conferences in the IP field. The high quality of the speakers is matched by the intense, audience-led debates and challenges which follow." Hugh Laddie, (formerly Mr. Justice Laddie) University College, London and consultant to Rouse & Co, Willoughby & Partners. "Faculty for this conference are always well-known 'names' well respected leaders in their fields, speaking with a combination of candor and timeliness that is unrivaled by any other forum of its kind." The Honorable Marybeth Peters, Register of Copyrights, United States Copyright Office.
Author : Anonim
Publisher : American Bar Association
Page : 462 pages
File Size : 46,7 Mb
Release : 2011-07-16
Category : Electronic
ISBN : 1604428864
For over 37 years, Antitrust Law Developments and its annual supplements have been recognized as the single most authoritative and comprehensive set of research tools for antitrust practitioners. The 2009 Annual Review of Antitrust Law Developments summarizes developments during 2009 in the courts, at the agencies, and in Congress.
Author : Anonim
Publisher : Unknown
Page : 286 pages
File Size : 42,9 Mb
Release : 2008
Category : Actions and defenses
ISBN : STANFORD:36105064217255
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy,Richard A. Feinstein
Publisher : Unknown
Page : 184 pages
File Size : 49,5 Mb
Release : 2010
Category : Business & Economics
ISBN : PURD:32754081070439
Author : Anonim
Publisher : Unknown
Page : 1364 pages
File Size : 55,9 Mb
Release : 2008-05
Category : India
ISBN : CORNELL:31924083443444
Author : United States. Congress. Senate. Committee on Homeland Security and Governmental Affairs
Publisher : Unknown
Page : 492 pages
File Size : 42,6 Mb
Release : 2024-05-19
Category : Electronic
ISBN : IND:30000154107878