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Author : Anonim
Publisher : DIANE Publishing
Page : 129 pages
File Size : 49,5 Mb
Release : 2002
Category : Electronic
ISBN : 9781428951938
Author : United States. Federal Trade Commission
Publisher : Unknown
Page : 136 pages
File Size : 40,9 Mb
Release : 2002
Category : Drugs
ISBN : UCR:31210019512472
Author : United States. Federal Trade Commission
Publisher : William s Hein & Company
Page : 113 pages
File Size : 44,6 Mb
Release : 2002-01-01
Category : Law
ISBN : 1575887452
"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 : Unknown
Page : 0 pages
File Size : 41,6 Mb
Release : 2002
Category : Patent medicines
ISBN : OCLC:759565319
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 150 pages
File Size : 44,7 Mb
Release : 2002
Category : Competition
ISBN : UVA:X005093558
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 142 pages
File Size : 46,7 Mb
Release : 2004-08
Category : Competition
ISBN : 0756742196
Hearing on whether innovator drug companies may be using questionable tactics to delay the entry of generic competitors. Witnesses: Mark A. Barondess; Lester M. Crawford, Acting Commr., & Daniel D. Troy, Chief Counsel, Food & Drug Admin. (FDA); Gregory J. Glover, Ropes & Tray, on behalf of PhRMA; Kathleen D. Jaeger, Pres. & CEO, Generic Pharmaceutical Assoc.; Sharon Levine, Assoc. Exec. Dir., the Permanente Medical Group, on behalf of RxHealthValue; & Timothy J. Muris, Chmn., Fed. Trade Comm. (FTC).
Author : Anonim
Publisher : DIANE Publishing
Page : 16 pages
File Size : 41,8 Mb
Release : 2010
Category : Drugs
ISBN : 9781437985535
Author : Kevin J. Hickey,Kevin T. Richards
Publisher : Unknown
Page : 58 pages
File Size : 44,6 Mb
Release : 2021
Category : Drugs
ISBN : OCLC:1274040129
Author : United States. Federal Trade Commission
Publisher : Unknown
Page : 128 pages
File Size : 40,8 Mb
Release : 2002
Category : Drugs
ISBN : OCLC:50438405
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 : Robin Feldman,Evan Frondorf
Publisher : Cambridge University Press
Page : 165 pages
File Size : 55,7 Mb
Release : 2017-06-09
Category : Law
ISBN : 9781107168480
In this book, Feldman and Frondorf explain how companies employ strategies that block generic medicines from the market and keep prices high.
Author : Christopher Scott Hemphill
Publisher : Stanford University
Page : 249 pages
File Size : 52,6 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 : 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 : 54,9 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 : United States. Congress. Senate. Committee on the Judiciary
Publisher : Unknown
Page : 120 pages
File Size : 46,6 Mb
Release : 2003
Category : Competition
ISBN : PURD:32754077084873
Author : United States. Cabinet Committee on Price Stability
Publisher : Unknown
Page : 174 pages
File Size : 49,7 Mb
Release : 1969
Category : Big business
ISBN : UIUC:30112064510438
Author : Anonim
Publisher : Unknown
Page : 88 pages
File Size : 45,7 Mb
Release : 1981
Category : Drugs
ISBN : UCR:31210024829986
