On April 15, 2002, Allergan received approval by the U.S. FDA for Botox Cosmetic (botulinum toxin type A) for the temporary improvement in the appearance of moderate to severe glabellar lines (brow furrow) in adult men and women 65 or younger. For this use, Botox would be marketed as Botox Cosmetic.
 Although already approved by the U.S. Food and Drug Administration (FDA) for a variety of lesser known medical conditions such as cervical dystonia, blepharospasm (uncontrollable blinking) and strabismus (crossed eyes), Botox was best known for an off-label use—relaxing facial wrinkles. Consumer and media familiarity of Botox was quite high for its use in smoothing facial wrinkles, as many “trendsetter” physicians had been using the product for a number of years among their image-conscious patients.
Although the level of product awareness for Botox was an advantage, it also created challenges in the pre-approval phase. Because Botox was not approved for cosmetic use in the U.S. and had achieved limited approval by other international regulatory agencies, Allergan was unable to proactively correct misperceptions often reported by the media. For example, many stories focused on the treatment as “botulism,” as opposed to a pharmaceutical product that is a “purified protein derived from a naturally occurring bacteria,” or how Botox resulted in “paralyzed muscles” when the affect was more like a “smooth and relaxed” softening of facial wrinkles.
One of the challenges was that Botox had an image of only being accessible to celebrities or the wealthy rather than to everyday people. It was important that the PR campaign not only penetrate top-tier beauty/fashion/grooming media but also general health/lifestyle media with “real people” rather than “celebrity” Botox Cosmetic experiences.
Another challenge was keeping media interest in the Botox Cosmetic story through a lengthy FDA-review process.
The clinical trials were the primary research. Market research followed. Research conducted during the pre-approval phase that was significant to building a communications platform included: Consumer research was conducted into the different types of facial enhancement options available. A continuum of treatment options was then developed to illustrate how a consumer may progress from one treatment type to the next. Charting facial enhancement options and the decision-making evolution helped to understand the end user and target communications according to where a consumer group may be along the continuum.
Key market research was conducted to determine the U.S. markets where Botox use, familiarity and potential for future use was greatest. These markets were ranked according to the “vanity factor”, which helped in the prioritization of media market targets, known as “vanity markets.”
For Burson-Marsteller to be able to identify which messages led to misperceptions and inaccuracies about the Botox product, a media audit was conducted. More appropriate messages were developed to convey key product attributes and results of treatment. Databank research from the scientific academies of Dermatology and Plastic Surgery provided useful information on the popularity and frequency of certain facial enhancement procedures.
 The strategic approach was to build a cadre of physician experts (primarily from vanity markets) who can advise on messaging; train other potential “injectors” to expand product use and how to safely administer; serve as spokespeople/advocates, emphasizing the ‘art and science’ of the Botox product. FDA approval was then leveraged to reinforce “science of Botox,”
Throughout the summer and fall of 2001, the internal Allergan PR team and the Burson-Marsteller PR team worked together to prepare for the FDA approval of BotoxCosmetic. One of the first activities was to work with a panel of dermatologists and plastic surgeons who were heavy Botox Cosmetic users, known as key “injectors,” to gain insight into their practice patterns and patient attitudes toward treatment.
A core message track was developed and refined that accurately communicated to both consumers and media the key product attributes and results achieved with a proper Botox Cosmetic treatment. This core message track was a critical component to the pre-approval communications preparation and was the foundation for all approval and post-approval communications for the product.
Strategic planning for the U.S. FDA approval of Botox Cosmetic began in May 2001. By Fall 2001, most materials and campaign elements were developed. Planning consisted mainly of the following: Designing a media preparedness plan for pre-approval interest in product and for leveraging media announcement at approval; Identification and training of physician “injector” advocates and patient advocates; Development of a core message track that included messaging for current therapeutic uses, data for aesthetic use under FDA review, importance of seeking treatment from a trained aesthetically oriented physician; Development of media materials ranging from fact sheets, backgrounders, briefing documents, speaker bios, video and radio news releases, etc.
To maintain and expand media interest in the brand, desk-side briefings were coordinated during pre-approval with key top-tier reporters to discuss the Botox brand. Attention was focused on a deeper overview of the versatility of Botox and discussed the varied therapeutic uses already FDA-approved and the uses in research.
 On the day of the FDA approval, April 15, 2002, Allergan and B-M conducted a “media blitz” to make the announcement. Outreach was conducted to national media, in addition to targeted local media in each of the Vanity Markets where relationships had been developed with key physician (dermatologists/plastic surgeons) thought leaders.
Press materials were distributed to top-tier media outlets nationally. Media interviews were arranged with Associated Press, New York Times, Wall Street Journal as well as a number of other top-tier wire services and broadcast news outlets such as NBC’s Today Show; a video news release was distributed to broadcast outlets nationally. To ensure “blanket” coverage of the FDA approval, stations in the Top-50 ADI markets were alerted to the availability of the VNR and b-roll package.
In an effort to reach the millions of radio listeners in America, a 60-second radio news release (RNR) was developed and distributed to all radio networks and stations across the U.S; A satellite media tour was coordinated with television stations across the U.S. featuring Dr. Heidi A. Waldorf, Assistant Clinical Professor, Department of Dermatology, Mt. Sinai School of Medicine and Amelia Verlin, a satisfied BotoxCosmetic user.
Media outreach was also conducted to broadcast television stations in the Top-100 ADI markets, as well to national and regional cable stations, to secure participation in the tour; a radio media tour was conducted with Dr. William H. Beeson, Assistant Clinical Professor, Departments of Otolaryngology, Head and Neck Surgery and Dermatology, Indiana University School of Medicine.
More importantly, to quote Allergan’s third quarter SEC-10Q report, “Sales of Botox increased by $90.3 million in the first nine months of 2002 compared to the same periods in 2001.” “Botox sales increased in both the United Stares and international markets…driven primarily by the April 2002 approval of BotoxCosmetic by the U.S. Food and Drug Administration (FDA).”
In post-FDA approval follow-up calls, “key injector” physicians reported that their “phones are ringing off the hook” with patients wanting to hear more about Botox Cosmetic.
In the last year, the Botox brand name has become so well known in the U.S., it is synonymous with the treatment. In most articles, the brand name is substituted for the longer generic name, helping to market the brand and protect it from competition. The SEC report states that ”Allergan believes that its worldwide market share is over 80 percent for neurotoxins including Botox.”