Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Off-Label Marketing of Drugs and Medical Devices
Policing the marketing of drugs and devices was once primarily the preserve of the Food and Drug Administration (FDA), which focused on misleading labels and outright quackery. No longer. Nowadays, many federal investigations, worked jointly by the FDA, Department of Justice (DOJ) and Health and Human Services (HHS), are fueled by the enormous financial recoveries that can be won from manufacturers accused of illegally promoting FDA-approved drugs or devices, bearing an FDA-approved label, for uses not approved by the FDA ('off-label' uses).
For example, Warner-Lambert pleaded guilty, paid $430 million, and entered into a 'Corporate Integrity Agreement' to resolve civil and criminal charges over off-label promotion of the drug Neurontin'. Other reported settlements relate at least in part to off-label allegations: Genentech ($50 million); Lilly ($36 million); Serono ($704 million); Schering-Plough ($435 million); Intermune ($36 million) and, more recently, Purdue Frederick ($470 million).
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- 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
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
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.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.