Sept. 13, 2002 -- Botox ads are wrinkling brows at the FDA.
Botox advertisements are misleading, the federal agency says. The charge comes in an FDA letter asking Botox maker Allergan Inc. to change its TV, print, and Internet ads.
The agency asks that Allergan immediately pull the ads until changes are made.
The FDA approves Botox only for one use: to paralyze the frown muscles between the eyebrows. Doctors, however, can use Botox any way they see fit. This has led to extensive use of the drug to freeze other wrinkle-causing face muscles.
It's perfectly legal for doctors to do this. But drug companies aren't allowed to promote their drugs for such uses. That's where Allergan is running into trouble.
The TV ads "strongly suggest that the product is intended to treat the signs of aging. ..." the FDA letter says. Botox brochures claim Botox "can dramatically reduce your toughest wrinkle." This may make people think the drug is approved for use in all kinds of wrinkles, the letter states.
The FDA has other problems with the ads:
- They don't clearly say that Botox treatment is temporary.
- They don't clearly say that Botox is approved only for use in adults 18 to 65 years old.
- They don't clearly say that Botox is approved only for use on wrinkles between the eyebrows.
Though the FDA has the power ultimately to seek a court order banning sales of a drug, there is no suggestion that such drastic actions will be needed. The relatively friendly "violative" letter uses the word "please" several times. It is the earliest and mildest rebuke in the FDA arsenal.
"The letter asks the company in 10 days to submit a response in writing and come to compliance," FDA spokesman Jason Brodsky tells WebMD. "[It] is the lowest level of enforcement."
Such a response will be ready in a few days, says Allergan spokeswoman Christine Cassiano.
"We strongly believe that this can be resolved amicably with FDA," Cassiano tells WebMD. "It is not something that we think will change our longstanding good relationship with the FDA."