Botox maker seeks to lift U.S. ban

Allergan Inc., maker of wrinkle treatment Botox, is challenging the government’s ban on marketing off-label uses for pharmaceuticals.

In a lawsuit filed Thursday, the Irvine company argued that it should be allowed to give doctors information about using Botox for treatments not approved by the Food and Drug Administration, including bladder problems, muscle spasms and headaches.

Botox is approved by the FDA for use cosmetically as a wrinkle treatment and medically for eye-muscle disorders, excessive underarm sweating and cervical dystonia in adults, which causes abnormal head positions and neck pain.

Though doctors can legally prescribe drugs for unapproved uses, it is illegal for companies to encourage doctors to use medications in ways not approved by the FDA.

Allergan says companies should be allowed to provide physicians with information on risks, benefits, dosage levels, limitations and what patients to treat in off-label uses, said Caroline Van Hove, an Allergan spokeswoman.


The company has compiled information about off-label uses of Botox, including benefits and safety issues, and would like to provide it to doctors, Van Hove said.

“We don’t want to promote off-label use, but we need to make sure physicians are using our products in the safest way possible,” she said.

To that end, Allergan is hoping the FDA will create regulations that require drug makers to inform doctors about off-label uses while encouraging physicians to take part in clinical trials and studies that will push off-label uses into government approval, she said.

Van Hove said Allergan estimates about 20% of Botox use in the U.S. is off label.

The lawsuit was filed in U.S. District Court for the District of Columbia against the FDA, as well as the heads of the FDA and the Department of Health and Human Services.

Megan Scott, an FDA spokeswoman, said the agency does not comment on pending litigation.