Back to news and insights
Article

The never-ending saga of off-label promotion

October 3, 2017

The concern of misbranded products leading to patient harm and potential fraud is inarguable.

Prescribing medicines off-label is a common practice, but with life science companies prohibited from sharing information about off-label uses, do physicians get the best available information to make sound clinical decisions?

Based on the Pharmaceutical Research and Manufacturers of America ("PhRMA") and the Biotechnology Innovation Organization ("BIO") principles, as well as the US Food and Drug Administration ("FDA") guidance, one thing is for sure - truthful and non-misleading communication will need to be supported by robust, comprehensive, and balanced scientific analysis.

In this article FRA's Jenny McVey will outline the industry's response to the continued lack of clarity around off-label communication and the long-awaited guidance from the FDA.

Read the full article in LSCU.

No items found.
Article

European Public Prosecutor's Office: A New Reality in EU Financial Crime Enforcement

August 14, 2025
Article

A Practical Discussion on Preparing for the UK Failure to Prevent Fraud Offence

July 25, 2025
Article

Revenue Recognition Frauds for Lawyers: Bill-and-Hold arrangements

July 25, 2025
News

Equal Representation for Expert Witnesses Spotlight Series Featuring Victoria Richards

July 25, 2025