Allergan Disputes FDA Marketing Restrictions on Botox
Closed Published by newseditor October 5th, 2009 in Botox® Cosmetic
Are marketing restrictions for off label Botox hindering the physician’s ability to provide safe treatment? Pharmaceutical company Allergan has argued as such, and filed a suit against the FDA to loosen the restrictions.
While Botox is typically used – and FDA approved – for treating wrinkles on the face and forehead, a wide range of other applications have been successfully performed. Doctors have used Botox to treat hyperhidrosis, migraine headaches, muscle spasms, and many other problems.
According to current U.S. law, physicians are allowed to administer medicine for whatever use they deem appropriate. They aren’t however, allowed to advertise or market medicine for any application under the sun.
The marketing restrictions placed on off-label Botox have evidently hindered Allergan’s ability to distribute safety information related to such uses. The current lawsuit 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 boost Botox sales.
