Court Approves Allergan Settlement of Botox Investigation
A federal judge has approved a $600 million settlement and guilty plea from Allergan, Inc., which has admited that it tried to market and sell Botox for unapproved uses.
On Tuesday, a U.S. District Court judge in Atlanta approved the Botox settlement between Allergan and the U.S. Department of Justice (DOJ). The settlement ends a criminal investigation into Allergan’s Botox marketing activities, which prosecutors say was aimed at increasing off-label sales for headaches, cerebral palsy, pain and spasticity. The settlement agreement was first reported in early September.
According to allegations raised in the lawsuit over Botox marketing, the company went as far as training doctors how to bill for unapproved uses and created a Botox Reimbursement Hotline to help doctors get reimbursed for using Botox in ways that have not been sanctioned by the FDA.
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Learn MoreThe terms of the settlement include an admission of guilt by Allergan, Inc., a criminal fine of $375 million, and a $225 million civil settlement with the federal government. The civil aspect of the settlement resolves allegations that the company’s off-label marketing practices included teaching doctors how to falsify reimbursement claims in order to trick the government into subsidizing the use of Botox for unapproved applications. The civil aspect includes several whistleblower lawsuits brought by plaintiffs who will share in the federal civil settlement amount.
Allergan has also agreed to a five-year corporate integrity agreement with the government. The corporate integrity agreement will include independent audits to ensure that the company is following federal drug marketing regulations.
While this guilty plea was considered a misdemeanor, a similar infraction in the future would be considered a felony. If Allergan is found guilty of a felony the U.S. Department of Health and Human Services would automatically exclude all of the company’s products from all government health programs.
Botox, which contains small quantities of the bacteria associated with the development of botulism poisoning, is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.
A number of problems with Botox have been reported among users, where the medication can spread from the area of the injection to other parts of the body. This can result in symptoms of botulism poisoning, such as paralysis, difficulty swallowing, respiratory distress and other issues. These Botox reactions have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.
Federal regulations make it illegal for drug companies to promote their products for uses that have not been approved by the FDA, even though it is legal for doctors to prescribe drugs for any use they feel is appropriate. However, doctors are rarely reimbursed by the federal government through Medicaid and other programs when they use drugs for such unapproved applications.
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2 Comments
MelissaOctober 11, 2012 at 12:55 pm
I have had tension headaches and migraines for several years . I went to neurologists, mds,ends,allergists, etc . I found an md /do who was able to taylor a program that helped me to lead an active life, and care for and adopt two special needs children. After my doctor moved out of FLorida, the group of doctors taking care of me did not want to continue with the same treatments. As I began show[Show More]I have had tension headaches and migraines for several years . I went to neurologists, mds,ends,allergists, etc . I found an md /do who was able to taylor a program that helped me to lead an active life, and care for and adopt two special needs children. After my doctor moved out of FLorida, the group of doctors taking care of me did not want to continue with the same treatments. As I began showing in the urgent care facility more often, they insisted I see one of their neurologists or they would refuse to give me a pain relief shot. (even though I had seen one of their neuros for about a year of treatment with seizure meds with no us uses) the doctor who became my new primary was with their group and I had already was on preventative treatment with him . As soon as I saw the neurologist he made it very clear to me that Botox was what he wanted me to do. I did not feel comfortable with it, and he basically showed no real interest in relieving my pain. Each time I went to urgent care the head of the facility always treated me like a criminal, and always spoke about Botox. I felt bullied into the treatment as my pain grew and was told the only side effect would be no headaches. After the Botox (which the doctor seemed to be toying with me because I had turned the lights out in the small room I was in- he said could give me the shots with the lights off because he's given them so many times he could do it with his eyes closed) I begged for him to turn the light on and he opened the blinds. I immediately went to the clinic after getting 24 injections in the back of my head , forehead ,etc. Those Botox injections changed my life for the worst. I began choking on any food that I tried to eat, and was advised to,wear a soft neck brace for a while. I felt excruciating, intolerable pain that had me bedridden for weeks on end, I begged for my doctor to put me in the hospital. Finally after 43days of excruciating pain and urgent care refusing to help me any longer my neuro put me in the hospital . I was in pain for everyday of the three week stay except for the last few. When another neurologist on call gave me a shot of geodon that gave me immediate pain relief. He told my husband that he needed to get me out of the hospital as my regular nuoarologistbwas on duty next. I got a notice from the medical group that I was no longer welcome as a patient. Of course, prompted by the neurologist. I was in the hospital when they sent he notice. That was 2008, today I am bedridden most days, have bouts of extreme hair loss, can no longer drive, and take pain meds from a pain management doctor e wry day. No one should have this much pain and how I wish I had not let them back me into a corner to get the Botox- but when you're in pain sometimes you have no voice and are at the mercy of the person treating you . I found out later that his paperwork said that he thought I had a mild form of cervical distonia and that's how he got my insurance to cover all but a portion . The one time that I wish they had denied a claim. I never could have afforded the $2000.00 worth of Botox otherwise. For me Botox took my pain from bad to excruciating, Im sorry that I,be misspelled several words but I can not figure out how to go back to correct. God bless
SocorroMarch 16, 2011 at 5:09 pm
I recv'd a botox injection and affected my neck muscles hard. I was told I was not a client for the botox at all. I seems to have caused more pain and more spasms that have recently gone from my neck to my left arm, back and just recently down my back to my bottom. I can not sit down due to major pain. I can sit for about 10 minutes and it takes alot for me to get up cause I have to completely b[Show More]I recv'd a botox injection and affected my neck muscles hard. I was told I was not a client for the botox at all. I seems to have caused more pain and more spasms that have recently gone from my neck to my left arm, back and just recently down my back to my bottom. I can not sit down due to major pain. I can sit for about 10 minutes and it takes alot for me to get up cause I have to completely bend and stretch my back to be able to get up vary slowly with alot of pain. I have been diagnosed with head injury, neck injury, shoulder injury and left arm/back injury due to an accident. I have since then been diagnosed with fibromyalgia, torticollis, no metabolism, I cannot go and have a normal bowel movement, can't tell til its time to do so and its get to a bathroom now. My arms go numb, hands, I swear I feel as my body is shutting down slowly even with stretching. I am scared.