Off-Label

In a pharmaceutical context, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service.

From the regulatory point of view, off-label is not merely unapproved but (at least to some extent) disapproved, and subject to secondary regulation.

• US Food & Drug Administration (FDA)
  
• UK Pesticides Saftey Directorate (PSD)
  

But off-label usage is apparently increasing. This raises several questions which I shall raise in separate blog postings. [Update: links added]

Innovation	The technological leading edge is often/always off the label.
Knowledge and Uncertainty	Off-label usage is disseminated by informal knowledge mechanisms ("samizdat").
Trust	On-label and off-label usage rely on different trust mechanisms.
Service-Based Business	There is a critical asymmetry between on-label and off-label, which must be accommodated in the geometry of services.