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Off-Label Promotion and Product Liability Considerations
Much has been written, including by us in January 2016, about the Food and Drug Administration's (FDA's) court losses in the area of off-label promotion (e.g., promotion of a pharmaceutical product's unapproved uses). The agency held a public meeting in November 2016, and it is unclear how and when the FDA will issue any guidance, if at all, on its enforcement policy toward off-label promotion. Nevertheless, companies must remember that the agency will continue to take enforcement action, as appropriate, and FDA enforcement letters are made publicly available on its website. As such, non-compliance with FDA rules increases product liability exposure. In addition, even if the agency does not act, inaction does not preclude a product liability claim if someone is injured as a result of an unapproved use promoted by the company.
Herein, we provide an update on the current regulatory landscape in the off-label promotional area and also review potential liability risks for companies to consider. We conclude with recommendations to reduce these risks.
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.
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.
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.
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.
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.