Allergan's recently announced $600 million settlement to resolve federal charges that it marketed Botox (onabotulinumtoxinA) for unapproved uses could hinder innovation and hamper patient care, some dermatologists worry. But in the long term, sources agree that the settlement will have little impact on the fortunes of the drug or its maker.
National report - Allergan's recently announced $600 million settlement to resolve federal charges that it marketed Botox (onabotulinumtoxinA) for unapproved uses could hinder innovation and hamper patient care, some dermatologists worry.
But in the long term, sources agree that the settlement will have little impact on the fortunes of the drug or its maker.
Under terms of the settlement with the Justice Department, announced Sept. 1, Allergan will plead guilty only to one criminal misdemeanor charge of misbranding Botox between 2000 and 2005, according to a company press release.
The department charged that Allergan undertook a systematic strategy to promote Botox for the unapproved indications of headache, pain, spasticity and juvenile cerebral palsy.
Botox is approved by the Food and Drug Administration (FDA) for treatment of strabismus and blepharospasm, cervical dystonia, severe primary axillary hyperhidrosis, glabellar lines and upper limb spasticity.
Additionally, Allergan will drop a First Amendment lawsuit in which the company had sought permission to share "truthful scientific and medical information" to help physicians evaluate risks and benefits of off-label treatment for spasticity, a company press release states.
Allergan also has entered into a five-year corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services, under which it will be required to publish information about its payments to doctors.
"We believe the settlement is in the best interest of our stockholders and employees, as (we) can spend our time and resources on the development of new medicines and devices instead of legal fees," Caroline Van Hove, Allergan vice president, corporate communications, tells Dermatology Times.
Dermatologists expressed surprise over Allergan's alleged wrongdoing.
Seth B. Forman, M.D., adds that the Allergan representatives he knows have never promoted off-label indications. He is a Tampa, Fla., private practitioner and assistant clinical professor of dermatology, University of Central Florida College of Medicine.
"Most of the companies are incredibly stringent, because they are aware that the federal government is looking to them as piggy banks," he says. Dr. Beer is director of Palm Beach Aesthetic Center, West Palm Beach, Fla.
The settlement - the latest in the Justice Department's continuing crackdown on off-label promotion of drugs by pharmaceutical companies - may have a dampening effect on future research, Dr. Beer says.
With drug manufacturers looking over their shoulders, "It is increasingly difficult to get medical science answers pertaining to potential off-label uses" that might help patients, because companies are afraid the FDA will construe such information as promotion, he says.
The settlement also will "stifle discussions that lead to innovations," Dr. Beer says. "If corporations cannot discuss future directions to research with the clinicians who treat patients, they will stop doing this in the United States and look abroad."