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The intersection of the False Claims Act with the FDA rules restricting the promotion of off-label uses of approved drugs has generated a confusing blend of public and private enforcement, primarily through settlements that provide little hard law. Many question whether this multi-billion dollar enforcement regime achieves its public policy goals. This white paper comprehensively describes how a False Claims Act case evolves, especially with regard to the relationship between the U.S. Department of Justice and the multiple interested federal and state agencies. While the traditional off-label promotion case may be waning, the white paper predicts and analyzes the next frontier of off-label enforcement - the provision of pharmacoeconomics information to pharmacy benefit managers, payers, and provider organizations. The paper draws from a thorough review of the cases, literature and numerous interviews with players in all sectors of the enforcement space, and exhaustively canvasses the challenges for all parties in reaching appropriate policy solutions. It ultimately recommends transparency, both in what is (and is not) "promotion" and in enforcement. The latter recommendations address both government sharing of information with qui tam relators when it does not assume control of a case and disclosure of the government's rationale for the remedies it seeks in negotiating settlements.
The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the misbranding provisions of the Food, Drug and Cosmetic Act could not prohibit a pharmaceutical sales representative's truthful statements promoting the off-label use of one of his company's products. The case fueled a growing debate over pharmaceutical commercial speech, with the industry declaring victory over needless government regulation while critics decried the erosion of the FDA's ability to protect the public from harmful drugs. Yet a parallel area of pharmaceutical litigation has, curiously, proceeded almost untouched. In the months both leading up to and after Caronia, companies agreed to multi-million- and even billion-dollar Civil False Claims Act settlements based on allegations that they caused false claims to be submitted to Medicare and Medicaid by promoting their products off-label. While Caronia did not address the FCA, logic suggests that if companies have a First Amendment right to discuss truthful off-label uses of their products, it is difficult to see how claims submitted when the drugs are prescribed for those very uses can be considered “false.” This inconsistency is problematic, and likely unsustainable. If pharmaceutical manufacturers are emboldened by Caronia to challenge these FCA prosecutions, the litigation likely will turn on the truth or falsity of the company's statements regarding off-label uses. Despite its name, however, the FCA is particularly unsuited to addressing what are at core disputes over medical and scientific data. In order to maintain the integrity of this key anti-fraud enforcement tool, it is crucial to separate questions about the truth of the claims for payment from questions about the truth of the underlying scientific statements. Because Medicare and Medicaid coverage determinations rely heavily on FDA approval, however, those issues are inextricably intertwined. This article explores why off-label promotion has been treated inconsistently in the First Amendment and FCA contexts, and the ways in which this trend highlights the limitations of the FCA as a panacea for health care fraud.
Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.
The 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.
This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.
Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply.
Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.