Maggiedoll wrote:
Apple_in_my_Eye wrote:
IIRC at least 50% of all prescriptions are written for "off label" use. The reason (I've heard) is because the FDA testing process for getting a drug approved is hugely expensive, so the drug companies only want to do it once for each drug -- since they know doctors can prescribe it for other reasons later, as they are discovered, without further FDA approval.
Not quite.. Pfizer was recently fined $2.3
billion for activity promoting off-label usage of their drugs.
Prescribing by physicians for off-label use is 100% legal and common. Promoting or marketing off-label use of a drug to doctors by a drug company is illegal.
That was Pfizer's mistake -- they knew doctors could and would (legally) prescribe off-label if they 'sold' them hard enough. If it were about the principle of off-label prescribing, then the prescribing doctors would've been fined.
http://commonlaw.findlaw.com/2009/09/pf ... fines.htmlQuote:
When a drug maker applies for FDA approval of a drug, it must specify the uses for which it seeks approval. Drug companies are only allowed to promote the drug for uses approved by the FDA. If a use is not specified in the approval application, or is specifically refused by the FDA, then it is an "off-label" use. Promoting the drug at dosages higher than that approved by the FDA also constitutes off-label promotion.
A doctor may still prescribe the drug for an off-label use, but marketing the drug for such a use is forbidden.
According to the plea agreement in the case of Pfizer and the anti-inflammatory drug Bextra, Pfizer was actually marketing the drug for off-label uses which the FDA specifically denied approval due to safety concerns.