Allergan Inc Files Suit Against FDA, Disputes Marketing Restrictions
Pharmaceutical co. Allergan Inc’s recently filed suit against the Food and Drug Administration contends that marketing restrictions placed on off-label Botox go against the best interest of patients and physicians.
Botox is commonly used – and FDA approved – for treating wrinkles on the face and forehead, but a wide range of alternative treatments have been successfully administered.
Doctors have used Botox to treat hyperhidrosis, migraine headaches, muscle spasms, and many other problems.
U.S. law permits physicians to administer medicine for whatever use they deem appropriate. However, doctors aren’t 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 off label uses of Botox. 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 according to Allergan, is in no way intended to boost Botox sales.