Off-Label Botox Marketing Gets $600 Million Fine

Allergan has been slapped with a $600M fine for illegally marketing Botox for off-label use.

After a years-long investigation, the company pled guilty to one misdemeanor charge of “misbranding.”

Allergan had marketed Botox to physicians for treating migraine and headache pain. In addition to advertising the drug’s off-label uses, the company allegedly also instructed doctors on how to “miscode” Botox insurance claims.

Though Botox is commonly used to treat a variety of facial wrinkles, it is only approved to treat the vertical lines (shaped like the number 11) between the brows. It has also been approved for treatment of spasms, eye muscle problems, and excessive underarm perspiration.

Botox is widely used for off-label treatments, including TMJ treatment, facial cosmetics, cerebral palsy treatment, and headaches. However, the manufacturer is not supposed to market the drug for off-label uses.

But Allergan has never been shy when it comes to marketing. In fact, the company filed a lawsuit last year arguing that the FDA should not be able to limit the manufacturer’s marketing and communications with physicians.

“In the lawsuit, Allergan contends that the Government’s legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.”

–Allergan Files Federal Lawsuit to Allow It to Share Relevant Information with the Medical Community on the Safe Use of BOTOX® for Common Therapeutic Off-Label Treatments

As part of this settlement, Allergan will drop that lawsuit.

The company has also been aggressively marketing Latisse, a new prescription medication that grows eyelashes. Ads feature celebrity users Brooke Shields and Claire Danes, showing off their longer lashes.

Of course, the warning included in their advertisements is enough to give the cosmetically-minded pause:

“LATISSE® may cause darkening of the eyelid skin which may be reversible. LATISSE® may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.”

Read more: Botox maker to pay $600M to resolve investigation