Botox maker refuses FDA demand to pull ads
IRVINE, Calif. -- The maker of Botox, the wrinkle-smoothing botulism toxin, is refusing a demand by the Food and Drug Administration to pull ads the agency says are misleading.
Allergan Inc. reacted angrily Monday to the FDA's order to "immediately cease distribution" of advertisements and brochures.
The FDA said the company's multi-million dollar ad campaign does not specify the particular wrinkles Botox is approved to treat, in violation of federal law.
The agency also said the Botox brochure misleads patients about the duration of a wrinkle-reducing injection, which is usually about four months. The Allergan Web site for physicians also led to confusion on dilution of the Botox solution, said Mary Malarkey, director of case management for the FDA's Center for Biologics Evaluation and Research.
Allergan said it will not pull the advertisements or the brochure.
"We strongly disagree on all points," said Allergan spokeswoman Christine Cassiano, adding that the company "worked diligently" with the agency to produce accurate materials.
Cassiano said the FDA has never previously indicated there was a problem.
The company has 10 days to provide a written response to the FDA demand, which is one step short of a federal warning in which the FDA outlines enforcement action to the Justice Department.
Botulinum toxin type A, or Botox, was approved by the FDA this year for use on a specific wrinkle that develops between the eyebrows and the forehead.