Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions
Author:
Publisher: DIANE Publishing
Published: 2010
Total Pages: 16
ISBN-13: 143798553X
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Drug Wars
Author: Robin Feldman
Publisher: Cambridge University Press
Published: 2017-06-09
Total Pages: 165
ISBN-13: 131673949X
DOWNLOAD EBOOKWhile 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.
The Antitrust Enterprise
Author: Herbert HOVENKAMP
Publisher: Harvard University Press
Published: 2009-06-30
Total Pages: 392
ISBN-13: 9780674038820
DOWNLOAD EBOOKAfter 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.
Delay, Deny, Defend
Author: Jay M. Feinman
Publisher: Penguin
Published: 2010-03-18
Total Pages: 241
ISBN-13: 1101196289
DOWNLOAD EBOOKAn expose of insurance injustice and a plan for consumers and lawmakers to fight it Over the last two decades, insurance has become less of a safety net and more of a spider's web: sticky and complicated, designed to ensnare as much as to aid. Insurance companies now often try to delay payment of justified claims, deny payment altogether, and defend these actions by forcing claimants to enter litigation. Jay M. Feinman, a legal scholar and insurance expert, explains how these trends developed, how the government ought to fix the system, and what the rest of us can do to protect ourselves. He shows that the denial of valid claims is not occasional or accidental or the fault of a few bad employees. It's the result of an increasing and systematic focus on maximizing profits by major companies such as Allstate and State Farm. Citing dozens of stories of victims who were unfairly denied payment, Feinman explains how people can be more cautious when shopping for policies and what to do when pursuing a disputed claim. He also lays out a plan for the legal reforms needed to prevent future abuses. This exposé will help drive the discussion of this increasingly hot- button issue.
Pay-For-Delay Deals
Author: Competition P. Subcommittee on Antitrust
Publisher: CreateSpace
Published: 2015-06-17
Total Pages: 134
ISBN-13: 9781514385494
DOWNLOAD EBOOKIn 2012, analysts estimate that Americans spent $325 billion on prescription drugs and they predict that drug sales will rise by more than four percent in the year 2014. Generic drugs, which can cost as much as 90 percent lower than brand-name drugs, help rein in the costs. A brand-name drug that costs $300 per month might be sold as a generic for as little as $30 per month, but for several years, pay-for-delay deals have robbed consumers of cost-saving generic drugs. At the very core, these deals involve collusion between brand and generic competitors to keep generic competition off the market. A brand-name drug company pays their generic competitor cash or another form of payment. In exchange, the generic delays its entry into the marketplace. The brand company wins because it gets to maintain its monopoly, and the generic company wins because they get paid more than they would have if they came to market. But American consumers and American taxpayers lose out on lower-cost generic drugs to the tune of billions of dollars each year, $3.5 billion according to the Federal Trade Commission.
Pay to Delay
Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Publisher:
Published: 2010
Total Pages: 184
ISBN-13:
DOWNLOAD EBOOKGeneric Drugs
Author: Christina M. Curtin
Publisher: Nova Science Publishers
Published: 2011
Total Pages: 0
ISBN-13: 9781611220711
DOWNLOAD EBOOKBrand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. "Pay-for-delay" agreements are "win-win" for the companies: brand name pharmaceutical prices stay high, and the brand and generic share the benefits of the brand's monopoly profits. Consumers lose, however: they miss out on generic prices that can be as much as 90 percent less than brand prices. For example, brand-name medication that costs $300 per month, might be sold as a generic for as little as $30 per month. This book examines the "pay-for-delay' program and how drug company pay-offs cost consumers billions.
Model Rules of Professional Conduct
Author: American Bar Association. House of Delegates
Publisher: American Bar Association
Published: 2007
Total Pages: 216
ISBN-13: 9781590318737
DOWNLOAD EBOOKThe Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Making Medicines Affordable
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2018-03-01
Total Pages: 235
ISBN-13: 0309468086
DOWNLOAD EBOOKThanks 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.
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law
Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
Published: 2018-08-14
Total Pages: 520
ISBN-13: 9403501146
DOWNLOAD EBOOKReverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
