How do you turn a little known drug approved for a rare eye muscle disorder into a 440 million dollar a year product? Use word of mouth advertising, add some key opinion leader support and inject extensive “off-label”1 usage as an anti-wrinkle agent and you are well on your way.
Allergan received FDA approval for their new drug as a therapeutic agent in 1989. Considered a weapon of mass destruction in large doses, Botox is a therapeutic drug when the dosage is minute. It is injected in very small amounts into a muscle and paralyzes it providing relief for the patient.
Although Botox languished for its first seven years on the market, one of its side effects became well known. This was its potential to reduce facial lines. During its rather inauspicious opening period, “off label”1 cosmetic users dabbled with the drug for these anti-wrinkle properties. By the 1990’s these physician “dabblers” had become outspoken advocates leading the way to Botox gaining FDA approval as a cosmetic agent in 2002.
Off label use of the drug became widespread because doctors loved the economics of administering Botox injections. In a new twist on house calls women were holding “Botox parties”. Suburban women would gather at a friend’s house to be administered Botox injections by a qualified doctor. With shots costing $300 to $400 per injection and lasting only three to four months, this was a great business model for doctors complete with well heeled, repeat customers. These parties were widely reported in the news media and helped Botox become the fastest growing non surgical procedure in the cosmetic industry.
Before its approval as a cosmetic agent the promotion of Botox was a tricky issue. All the anti aging hype raised a few eyebrows over at the FDA and created a few worry lines on Allergan executives.
Officially, Allergan distanced themselves from Botox parties and positioned the company as a responsible, conservative corporation that developed Botox first for a medical rather than cosmetic use. They funded numerous studies testing the drug’s efficacy on a number of medical conditions including migraine headaches, cancer and back pain. The purpose of these studies was two fold, first to find new markets but more importantly to create a body of evidence proving the safety of Botox. This body of evidence became important when it came to getting FDA approval for Botox to be used as a cosmetic agent.
Botox, of course, continued to ride the wave of “word of mouth awareness” fueled by media reports of this miracle anti-aging remedy. As well, Allergan hired an outspoken husband and wife doctor team who were heavy advocates of the product as a cosmetic agent. The drug moved out of its ‘luxury indulgence’ box and enlarged its market further when a book was written by a prominent dermatologist promoting Botox as a wrinkle remedy for women who wanted to “look their best at any age”.
Keep your eyes open and exploit opportunities as they arise! Allergan took a treatment for a rare eye muscle disorder and turned its side effect into a 440 million dollar a year business. Feeling a little stressed from time to time? No worries – just inject a little Botox here and there to smooth out those lines.
1. Off label – Using a drug for conditions that it is not approved for. This is not illegal but a company can only promote a drug for medical conditions for which is has received FDA approval
2. “Beautiful Skin: Every Woman’s Guide to Looking Her Best at Any Age” Dr. David Bank and Estelle Sobel, Adams media 2000
3. Case studies, Best Practices LLC Botox