Isn't this supremely frustrating? My doctor informed me how many more drug options for PD exist in other countries and says hold up here is FDA. I understand the need for safety and standards but when it is an already well-established drug?!? Plus used for years in other counties where there is an historical record of use? I don't get it other than that there is no "sponsor" (meaning pharmaceutical corp owning it or re-marketing it for profit) behind it for the FDA to approve it for off-label use. Meaning it is about profit; there is no patent to be file, no high priced designer drug, and no monopoly.

Is there anyone who knows the pharma trade and FDA to explain why this happens? Or maybe given its success in other countries why doctors here won't prescribe it off label? ...besides malpractice threat?

Laura