Healthy Skepticism Library item: 14514

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Fugh-Berman A, Melnick D.
Off-Label Promotion, On-Target Sales.
PLoS Med 2008 Oct 28; 5:(10):e210
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050210

Abstract:

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 specific approved (“labeled”) uses.

Once a drug is approved for at least one indication, it may be prescribed off-label for a different condition, a different population, or in a different dose than what the drug is approved for. However, off-label uses have not been subject to the testing and review that is a precondition for marketing approval. The scientific review of evidence of effectiveness and safety that regulators weigh prior to approval for a labeled indication protects the patient. With off-label use, this protection often does not exist.

Off-label prescription of a drug is generally legal, but promotion of off-label uses by a drug manufacturer is usually illegal. This paper addresses public health issues associated with off-label use, and describes techniques by which pharmaceutical companies covertly promote off-label use even where such promotion is illegal.

Risks and Benefits for Patients

Risks-and Benefits-for Profits

How To Promote Off-Label

Commentaries and Case Studies

Marketing via Meetings: Abstracts and Posters

Medical and Graduate Education

The Role of Reps

Coverage through Compendia

Discussion/Conclusions