According to an FBI press release, Allergan Inc. - the maker of Botox - has agreed to pay $600 million in criminal and civil penalties for violations of the False Claims Act. The FBI’s consumer fraud unit conducted a three year investigation into Allergan’s fraudulent promoting of Botox for non-FDA approved off-label sales to patents suffering from headaches, pain, spasticity, and juvenile cerebral palsy. In addition, the FBI probe uncovered numerous instances of illegal kickbacks paid to physicians who prescribed Botox for non-cosmetic purposes.
Allergan’s crimes first came to light in Atlanta in 2007 when a local physician and an Allergan employee came to the FBI to complain about Allergan’s practices. The subsequent investigation found that Allergan’s fraudulent practices were not confined to the Atlanta area, but rather encompassed a corporate-wide strategy to expand Botox sales outside of the cosmetic pharmaceutical arena. As stated in the press release:
“U.S. Attorney Yates said Allergan made ‘hundreds of millions of dollars’ promoting the off-label uses of Botox. And Tony West, Assistant Attorney General for the Department of Justice’s Civil Division, pointed out that this is not a victimless crime.
‘When our public health care programs are burdened with fraudulent charges, it drives the cost of health care up for all of us—consumers pay more in premiums, companies pay more to cover their employees’ West explained. ‘And when a pharmaceutical manufacturer violates the integrity of the drug approval process established by Congress and the FDA by paying kickbacks to encourage the off-label use of an unapproved drug, that not only undermines the judgments of health care professionals, it also threatens to put patients’ health and safety at risk’.”
Kudos to the FBI and the US Department of Justice for their gallant efforts in bringing this case to light. Their actions should send a strong message to all US pharmaceutical companies that FDA regulations are put in place to protect the public, and that any act that compromises the public’s safety in order to increase profits cannot be tolerated.
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Frank Michels
Kent Pitman
markinjapan
old new lefty
Steve Klingaman
Alan Nothnagle
Salon.com
Comments
You bring up some good points. I’ll be the first to admit that I know nothing about FDA licensing procedures, and even less about the inner workings of the pharmaceutical industry. I did a little research on the origin of Botox, and you are correct that it was originally developed for non-cosmetic use.
However, one has to wonder:
“If Botox is a ‘real and valid treatment’ for the ailments you mentioned, why didn’t Allergan have it approved by the FDA for treatment of these ailments?”
And, “Why did physicians accept under-the-table kickbacks for prescribing Botox for these off-label ailments.”
And, “Why did Allergan pay a $600 million out-of-court settlement if they felt that their off-label use of Botox was legit?”
A $600 million settlement is a pretty strong statement of wrong doing.
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