Download or read book Paying Off Generics to Prevent Competition with Brand Name Drugs written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2007 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Paying off generics to prevent competition with brand name drugs should it be prohibited hearing written by and published by DIANE Publishing. This book was released on with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book H R 1706 the Protecting Consumer Access to Generic Drugs Act of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection and published by . This book was released on 2012 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pay to Delay written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy and published by . This book was released on 2010 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Law and Economics of Generic Drug Regulation written by Christopher Scott Hemphill and published by Stanford University. This book was released on 2010 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Protecting Consumer Access to Generic Drugs Act of 2007 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection and published by . This book was released on 2007 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report on the Activities March 31 2009 111 1 Senate Report 111 11 STAR PRINT written by and published by . This book was released on 2009 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Hastings Law Journal written by and published by . This book was released on 2013 with total page 676 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative and Executive Calendar written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2007 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Hastings Journal written by and published by . This book was released on 2008 with total page 796 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Managed Care Pharmacy Practice written by Navarro and published by Jones & Bartlett Publishers. This book was released on 2008-12-11 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.
Download or read book Legislative and Executive Calendar 110 1 2 Committee on the Judiciary S Prt 110 57 Final Edition written by and published by . This book was released on 2010 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Indiana Health Law Review written by and published by . This book was released on 2008 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 1963 with total page 1462 pages. Available in PDF, EPUB and Kindle. Book excerpt:
