Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Product Liability Law & StrategyKickerFeaturesSectionsNewsLJN Newsletters

Considerations When Disseminating Off-Label Information

By Alan Minsk and David Hoffman
March 31, 2004

How is the dissemination of information regarding an unapproved indication for an approved drug or medical device like speeding on the highway? You might not get caught, but it can be dangerous and it might land you in court.

Most pharmaceutical and medical device companies promote their products for unapproved ' or off-label ' uses. The term “off-label” as used in this article refers to a situation in which the Food and Drug Administration (FDA) has approved or cleared the sale of a product for a particular indication, but a company markets it for a different use. Companies can make millions of dollars on off-label sales and, in some cases, the sales associated with off-label use are more profitable than sales associated with the authorized indication. Off-label promotion is a business reality. However, gains from off-label promotions can be quickly offset by costs associated with product liability litigation and the loss of good will within the medical and consumer communities.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

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 Image

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 Image

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 Image

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 Image

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.