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Off-Label Marketing and the First Amendment
Prosecutions for “off-label marketing” by manufacturers have become an important component of the government's health care initiative. “Off-label” usage of prescription drugs and medical devices refers to using a product for a purpose that is not specified in the labeling approved by the Food and Drug Administration (FDA). Manufacturers are prohibited from promoting off-label uses of their products, but health care providers may prescribe or use them as they choose, whether or not the use fits within the FDA-approved “label.” 21 U.S.C. ' 396.
Government fines and criminal prosecutions against manufacturers for promoting “off-label” uses have surged, especially for pharmaceuticals. In 2009 alone, the Department of Justice (DOJ) announced the largest health care fraud settlement in U.S. history ' a $2.3-billion settlement with Pfizer arising from the off-label promotion of certain pharmaceutical products. Eli Lilly, Bristol-Myers Squibb, and Novartis have also entered into multi-million-dollar settlements. AstraZeneca agreed in April 2010 to a $520 million settlement in connection with off-label marketing.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.