Allergan reacted angrily to FDA notice-of-violation order on company’s botox ads and brochures. Allergan Inc. is refusing a Food and Drug Administration demand to pull allegedly illegal and misleading television ads and patient brochures for wrinkle-erasing Botox Cosmetics.
Allergan reacted angrily Monday to the FDA notice-of-violation order that the Orange County firm “immediately cease distribution” of advertisements and brochures, claiming they violate federal law and contain misleading information.
Allergan’s brochure misleads patients on duration of a wrinkle-reducing Botox injection, which is usually about four months, said Mary Malarkey, director of case management for the FDA’s Center for Biologics Evaluation and Research. The agency also said the Allergen Web site for physicians led to confusion on dilution of the Botox solution.
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 that would be taken to the Justice Department.
Allergan said it will not pull the advertisements or the brochure
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 about Botox Cosmetic.
Cassiano said the FDA has never previously indicated there was a problem.
The FDA has responsibility for policing ads for drugs and products such as botulinum toxin type A, or Botox, which was approved by the FDA this year for use on a specific wrinkle that develops between the eyebrows and the forehead.