Law.com Subscribers SAVE 30%

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

Product Liability Law & StrategyCommercial LawFeaturesLitigationLJN NewslettersProducts Liability

Off-Label Promotion and Product Liability Considerations

By Alan Minsk
February 01, 2017

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.

This premium content is locked for Entertainment Law & Finance 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
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It Image

Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?

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.

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.

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.

Protecting Innovation in the Cyber World from Patent Trolls Image

With trillions of dollars to keep watch over, the last thing we need is the distraction of costly litigation brought on by patent assertion entities (PAEs or "patent trolls"), companies that don't make any products but instead seek royalties by asserting their patents against those who do make products.