Allergan Raises Eyebrows With Response To FDA Concerns About Botox Ads

Allergan plans to meet with FDA to discuss the agency's concerns with its direct-to-consumer ads for Botox Cosmetic (botulinum toxin A).

Allergan's initial response to a Sept. 5 letter from the Center for Biologics Evaluation & Research Advertising & Promotional Labeling Branch requesting cessation of the ad campaign raised the possibility of a court challenge to the agency's DTC policy. The company said that it did not intend to withdraw or revise the ads.

However, in a Sept. 12 press release, the company struck a more conciliatory note.

"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," Allergan said. A written response is due by Sept. 16.

"In recent media accounts, the impression has been given that Allergan intends to 'take on the FDA' over the Sept. 5 letter. This is incorrect. Allergan has the highest regard for the FDA and for...CBER, with which Allergan has worked productively for many years."

"If, after discussions with the FDA, changes to marketing material are ultimately required, Allergan will of course make those changes."

Allergan's press release follows comments from FDA General Counsel Daniel Troy at a Food & Drug Law Institute meeting Sept. 11 stressing that the general counsel's office stands behind all agency ad letters (see ¹ (Also see "FDA Chief Counsel, Ad Division Concur On 94% Of Violation Letters, Troy Says" - Pink Sheet, 16 Sep, 2002.) ). "Take them seriously because we are prepared to back them up by litigation, if need be," Troy said. "That doesn't mean we're not open to people coming back and saying, 'I think you've made a mistake here.'"

Advertising and Promotional Labeling Branch Chief Glenn Byrd told FDLI that he expects an amicable resolution. "We are aware of the concerns that have been raised by the manufacturer regarding our letter....We will work very closely with Allergan and with our Office of Chief Counsel to ensure that we come to a mutual exchange and agreement."

The ² Sept. 5 CBER letter says Allergan's "WOW" TV commercial does not qualify as a "reminder" ad campaign and so needs risk disclosure.

"These ads, which (1) focus attention on complexion and image, (2) make repeated references to age, and (3) make the statement, 'Ask your dermatologist or plastic surgeon about Botox Cosmetic'...strongly suggest that the product is intended to treat the signs of aging or glabellar lines," FDA said.

The letter asks Allergan to immediately stop broadcasting the "WOW" ads until they have been revised and submitted to FDA for review.

In addition to the TV reminder ad, the letter cites a Botox patient brochure that says: "It seems like everybody is talking about Botox Cosmetic, the highly effective, non-surgical procedure that can dramatically reduce your toughest wrinkle within 7 days."

The brochure's statement is misleading "because it does not emphasize that this is a temporary procedure," FDA said. "In addition, the term 'toughest wrinkle' does not adequately specify the approved indication for use and misleadingly suggests that Botox Cosmetic is for use in all tough wrinkles."

Washington Legal Foundation Chief Counsel Richard Samp told FDLI that FDA would have a tough time defending that part of the letter in court. "The fact that you don't specify precisely which wrinkles - I am not sure a court would really say that that is false or misleading," Samp said. He suggested that if Allergan did choose to fight the letter, "perhaps we'll get a better understanding from the courts of precisely what false and misleading is."

Botox was approved for temporary improvement in the appearance of glabellar lines (brow furrow) in April. At that time, Allergan Senior Product Manager-Botox Cosmetic Darren Innouye noted that he expected CBER to keep a close eye on Botox promotions. "They are going to be very vigilant on our promotional campaigns, DTC broadcast as well, so we're concerned about that" (³ , p. 4).

Allergan received an FDA warning letter on Botox in August 2001 for omitting risk information included in the drug's labeling from its website. FDA also questioned third-party promotions of Botox as a wrinkle treatment before the indication was approved (⁴ (Also see "DISCLOSURE OF UNAPPROVED STATUS OF PRODUCTS DOES NOT PREVENT EXCHANGE OF INFO ON OFF-LABEL USES, FDA MAINTAINS IN REQUEST FOR COMMENTS ON CME POLICY" - Pink Sheet, 21 Nov, 1994.), p. 12).