In a lengthy statement on its website Allergan acknowledged the settlement and said it had been cooperating with the government's investigation. The company said "agreed to plead guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005."
It added, "These uses were off-label during the relevant time frame and thus the labeling for BOTOX(R) did not bear directions for these intended uses, resulting in the product being misbranded."
Allergan, however, says that earlier this year, it received FDA approval for Botox to be used for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity," so the product now includes instructions for this use.
Based on conclusion of clinical trials, it has filed an application with the FDA to approve the product for treating migraine headaches.
The Justice charges included the following:
Allergan's marketing tactics violated the Food Drug and Cosmetic Act, which requires a company to specify each intended use of a biological product. After the FDA approves the product as safe and effective for a specific use, any manufacturer promotion for other uses, known as "off-label" uses, renders the product misbranded, Justice officials say.
In 1989, the FDA approved Botox, a prescription biological product containing botulinum toxin type A, a purified neurotoxin, to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contractions). In 2000 and 2004, approval was given to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excess underarm sweating), respectively. In 2010, approval was given to treat adult upper-limb spasticity.