Allergan Disputes Botox Marketing Restrictions

It was announced last Friday that Botox manufacturer Allergan Inc filed suit against the United States FDA, arguing that restrictions placed on marketing off-label Botox are not in the best interest of patients or physicians.

The lawsuit isn’t intended to increase Botox sales, but rather increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. regarding off-label applications.

Although Botox is typically used (and approved) to treat wrinkles on the face and forehead, a breadth of other treatment applications exist.

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.