Regulating Off-Label Promotion — A Critical Test

Prohibition against off-label drug promotion challenged.

Off-Label Promotion, On-Target Sales

For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug approved for acne. Government regulatory bodies review laboratory, animal, and human data to confirm that a drug has the claimed efficacy and safety prior to approving its release in the market for specif...

Regulating off-label promotion of medications: has the pendulum swung too far?

Prescribing medications off-label is commonplace in dermatology. Recent policy changes on the regulatory abilities of the US FDA and legal precedents regarding this topic have led to intense debate on free speech about off-label drug use by physicians and drug manufacturers. Here, we summarize and discuss the risks and benefits of off-label promotion and how this relates to quality patient care...

An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion

Spencer Phillips Hey and Aaron Kesselheim propose that informativeness-asserting scientific facts-rather than truthfulness ought to be the standard for regulating commercial speech about pharmaceuticals.

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012

BACKGROUND European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated ...