Allergan Inc., manufacturer of Botox cosmetic has filed suit against the U.S. FDA, arguing that restrictions placed on marketing off-label Botox work against the best interest of patients and physicians.
Although Botox is typically used (and approved) to treat wrinkles on the face and forehead, a wide range of other treatment applications exist.
The FDA announced last year that Botox complications had been linked to off-label use, particularly in children treated for limb spasticity. According to current U.S. law, physicians are permitted to administer medicine for any application they deem appropriate. They aren’t however, allowed to market medicine for any application they please.
Such marketing restrictions have apparently hindered the pharmaceutical company’s ability to distribute safety information related to off-label Botox use. The suit is intended to increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. and is in no way intended to increase sales of the drug.
Tags: Botox
