Botox maker Allergan expects to spend $25 million to $35 million this year in connection with a Department of Justice probe of its marketing operations.
The federal investigation is focused on whether Allergan has promoted uses of Botox beyond those that have been approved by the Food and Drug Administration. The only approved cosmetic use of Botox is for smoothing wrinkles between the eyebrows, but doctors are allowed to inject it for any purposes they believe are medically appropriate.
David Pyott, chief executive and chairman of the Allergan board, told stock analysts in a conference call on Wednesday, July 30, that the probe covers the company’s marketing of Botox from January 2000 on.
On March 3, Allergan received a subpoena for documents related to the probe.
Asked how long the investigation was likely to continue, Pyott replied, “These things can take years.”
Allergan says it does not promote unauthorized uses of Botox.
In March, the company said it believed the subpoena focused on educational and promotional materials related to use of the weakened form of botulinum toxin for therapeutic uses, rather than as a wrinkle fighter.
“Allergan’s current understanding is that the inquiry involves questions regarding alleged off label promotion relating to the use of Botox for the treatment of headache. While Allergan is currently in phase III clinical studies investigating the use of Botox for the treatment of headache, this is not an FDA-approved use,” the company said.
A lawsuit filed earlier this month on behalf of Botox patients said Allergan markets Botox to doctors and patients “as a panacea for a large assortment of illnesses and cosmetic purposes.”
“Allergan-sponsored medical conferences promote Botox as an off-label panacea for over 100 ailments, including cerebral palsy, whiplash and headaches,” the suit said.
Related links:
- Botox, fillers more popular despite slow economy
- Allergan gets subpoena for Botox promotion documents
- 9 challenges to the reign of King Botox
- Therapeutic Botox led to four deaths, says lawsuit
- Survey: Is Botox Cosmetic safe?
- Health advocacy group blasts Comaneci, Spitz for Botox tour
I’ll bet they didn’t even flinch
I know the inner-works of Allergans Neurosciences Marketing: Even the most unethical people in the bussiness would be baffled. It is not upper management, it is the mid-level marketeers and their agencies that run the show.
Botox(r) is a magnificent compound, in the hands people often out-of-integrity
There are other problems than those shown above:
1) the Aesthetic Czar at Allergan was a Canadian physician who injected
Botox in the USA though he was unlicensed and did
not have a green card
2) This same individual altered data in a critical Botox dilution trial, This
was brought to the attention of Mr Pyott. Shortly thereater I was
fired as a consultant
Feds are investigating whether Allergan promotes unauthorized uses of the injectable toxin.