Off Label Prescription Drugs

Off label use
Evergreening
Off-label marketing

This back door approval of a drug for uses other than those for which it has been through clinical trials and safety testing is facilitated by it being legal to prescribe a drug for a different condition other than the original once it has been approved for that primary use. The patient will almost certainly not realise that it is solely the prescribing doctor's opinion that directs the use of this legal prescription drug, but for a different ailment. The patient generally trusts the doctor to make an accurate diagnosis and then a suitable safe (possible) remedy. This practice is potentially very dangerous since the original trial should involve the specific disease area and initially healthy patients (Phase I) before moving to patients suffering from the condition for which the drug is intended (Phase II). Finally, Phase III may last between 2-4 years and is essentially an extended period of Phase II. The financial overheads for running clinical trials are very high and time-consuming (during the fixed and limited patent period), though entirely designed (in principle) to safeguard the ultimate user: the patient who is suffering from the condition and is therefore very vulnerable.

Drug (Therapeutic) Evaluation

It is unlawful to market, advertise or otherwise promote the off-label use of drugs, including controlled substances, though not to prescribe once a license has been approved and granted.

The doctor should be asked about the product history of the proposed medicine. Is it primarily for the condition that has been diagnosed?