Evergreening

Evergreening
Off Label Prescription Drugs

The ground between 'evergreening' and 'off label prescribing' becomes very shadowy. Evergreening involves the manufacturers of a particular drug restricting or preventing competition from a generic (equivalent) to that drug by extending the original patent (before it expires). Applying a drug to another (untested) situation while still covered by patent is known as off label prescribing and does not require any clinical trials. The assumption being that if a drug is safe for one condition and manufactured to the same ethical standard, then it is an acceptable practice. And safe. It relies totally on the knowledge of the prescribing doctor and accurate and complete information.

Those doctors are constantly targeted

by company salesmen

Consider the use of an aircraft that has been passed and approved for conveying passengers through the air. But used as a means of transport on a public road. The original use of the device (plane) has been approved, so the assumption could be that it is safe and appropriate to use on a road.

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?