Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Off-Label Promotion and Product Liability Considerations
The Food and Drug Administration ('FDA') prohibits the pharmaceutical industry from promoting products for off-label uses, unless certain prescribed statutory and regulatory requirements are met. A company may choose, although ill advised, to ignore this regulatory prohibition and admonition, but it must consider what happens when unfavorable events occur.
It is well documented that government bodies are scrutinizing companies' promotional efforts, particularly marketing of products for unapproved uses, commonly referred to as 'off-label promotion.' These government bodies include: Congress; the Food and Drug Administration; the U.S. Department of Health and Human Services' Office of Inspector General; the Justice Department; and state attorneys general. Of course, it is important for any company to consider the regulatory implications of disseminating off-label information. However, it is shortsighted for companies not to consider potential product liability implications of off-label promotion.
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.
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.