Botox marketer squelches media speculation on FDA letter response
IRVINE, CA., Sept. 12, 2002 -- Allergan issued a comment on the FDA's untitled letter dated September 5, 2002 regarding certain Botox Cosmetic marketing material.
In the September 5 letter, the FDA raised concerns with a portion of Allergan's promotional material for Botox Cosmetic. Allergan said it is currently engaged in preliminary discussions with the FDA and intended to respond to the untitled letter by September 16, 2002.
"In recent media accounts, the impression has been given that Allergan intends to 'take on the FDA' over the September 5 letter. This is incorrect," said David E.I. Pyott, Allergan's Chairman of the Board, President and CEO. "Allergan has the highest regard for the FDA and for its division, the Center for Biologics Evaluation and Research (CBER), with which Allergan has worked productively for many years.
"CBER has been very reasonable in its review of Allergan's marketing material for Botox Cosmetic, and I have no reason to believe they will be anything but reasonable here.
"CBER has raised some concerns about some of our material, which is their right, as it is our right to provide a detailed written response for their review. I am quite confident that we will be able to address CBER's concerns to their complete satisfaction, as we have always done in the past.
"It would be premature for Allergan to make any decision about the untitled letter without providing the FDA with a response and engaging in a meaningful discussion with the FDA. This is the normal process after a routine review and comment by the FDA on promotional items.
"If, after discussions with the FDA, changes to marketing material are ultimately required, Allergan will of course make those changes."
Source: Allergan, Inc. www.allergan.com
Posted: September 2002