A physician, M.D. or D.O., licensed to practice medicine or surgery in a state within the USA has the ability to write prescriptions for most medications. This includes drugs for off-label use. Revlimid was and is being used off-label today. Pharma companies cannot and do not advertise or advocate off-label use of drugs, but it is "suggested" by drug reps within the confines of doctor's offices or verbally in one on one encounters. This is enabled by published trial results in peer reviewed journals, and presentations by thought leaders at medical conferences. Off-label statistics, although well known by pharma companies, are never released in the public domain or commented upon. That would be illegal, and subject to fine. The FDA has been lax, the practice has been condoned and kept in the shadows. It has been left up to the doctor's good judgement, which at times is sorely lacking. However, there are more stumbling blocks, as PBMs and insurance drug plans may request further information or documentation on the indication to authorize filling of the prescription. The FDA is furthering efforts to prohibit off-label use of drugs, and this will be a major topic of debate going forward, especially if Obamacare is implemented.