Off-Label Promotion, On-Target Sales

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...

Prohibition against off-label drug promotion challenged.

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.

Sales Promotion Models

Firms spend a significant part of their marketing budgets on sales promotions. Retail (2012) indicates that during 1997–2011, promotion accounted for roughly 75% of marketing expenditures for US packaged goods manufacturers; the other 25% was for advertising. In 2011, 58% of the budget was spent on promotion to the trade (i.e., from manufacturers to retailers), and 15% on manufacturer promotion...

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 ...