Allergan, Inc., the maker of wrinkle-smooting Botox, has agreed to pay $600 million to settle a year-long federal investigation into its marketing of the top-selling, botulin-based drug. The investigation, involving charges of paying kickbacks to induce physicians to inject Botox for off-label uses and teaching doctors how to bill for off-label uses, including coaching doctors how to miscode Botox claims leading to millions of dollars of false claims being submitted to federal and state programs, was started by a whistle-blower complaint. The Justice Department says the company will plead guilty of one misdemeanor charge of “misbranding.” (Allergen also reached an agreement with the Department of Health and Human Services’ Office of the Inspector General that requires the company to submit compliance reports, and to post on its website any payments to doctors, such as honoria, travel or lodging.”
Manufacturers are prohibited from promoting drugs for unapproved, or “off-label,” uses. Botox is approved by the F.D.A. to treat uncontrolled blinking; crossed eyes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. It also is approved for cosmetic purposes — to smooth lines between the eyebrows – and two weeks ago, ironically, it was approved as a treatment to prevent chronic migraine headaches, one of the charges for which it agreed to pay the $600 million.
The misuse of prescription drugs, both purposely and through negligence, happens frequently and often has dire consequences. If you or a loved one may be the victim of such misuse, please contact our office for a free, confidential consultation to discuss your case.
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Jeffrey P. Gale, P.A. is a South Florida based law firm committed to the judicial system and to representing and obtaining justice for individuals – the poor, the injured, the forgotten, the voiceless, the defenseless and the damned, and to protecting the rights of such people from corporate and government oppression. We do not represent government, corporations or large business interests.