Botox Marketing Charges Settled

Allergan Inc., has agreed to settle a federal investigation over how it marketed <"">Botox, said the Associated Press (AP). The settlement becomes official once a federal judge approves it, said the AP, noting that officials at Allergan will appear in federal court today. The Botox probe lasted one year, with the Justice Department looking at Allergan’s marketing of Botox from 2001 through 2008, said the AP.

In a statement released yesterday, the Justice Department and Allergan announced that the drug maker will plead guilty to one misdemeanor charge of “misbranding” in which Allegan provoked doctors to use Botox off-label for “headache, pain, spasticity, and cerebral palsy in children,” said the AP. Off-label uses are not approved by the U.S. Food and Drug Administration (FDA); however, while physicians are free to prescribe approved drugs for nonapproved uses, it is illegal for drug makers to market approved medications for nonapproved uses.

Last April, the FDA mandated a black box label for Botox and similar products, warning of the risk of adverse events when the effects of a botulinum toxin injection spread beyond its injection site. The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving injections. The most serious cases involved hospitalization and death, and occurred mostly in children treated for cerebral palsy (CP)-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

As part of the plea, Allergan said it would pay $375 million, which includes forfeiture of $25 million in assets, as well as $225 million in civil fines, said the AP. This includes $210 million to the federal government—the rest to a number of states—connected to the probe, said the AP. Allergan denies liability for the civil claims, added the AP.

In a related deal, Allergan, will submit compliance reports to the Department of Health and Human Services’ Office of the Inspector General and will post physician payments, including honoraria, travel, or lodging, on its website, said the AP. Allergan “paid kickbacks to induce physicals to inject Botox for off-label uses and Allergan also taught 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 to submitted to federal and state programs,” Assistant Attorney General Tony West said, quoted the AP.

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA,” said Sally Yates, U.S. Attorney for the Northern District of Georgia, quoted the AP. “Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.”

A whistleblower complaint led to the probe; the five whistleblowers will split $37.8 million of the government’s settlement, explained the AP.

Earlier this year we wrote that a Botox overdose was blamed for the death of a seven-year-old Kristen Spears, who died in November 2007 of respiratory failure and pneumonia after receiving Botox injections to treat her severe CP. Her mother filed a lawsuit against Allergan. According to the lawsuit, Kristen began receiving Botox injections when she was six to calm CP-related leg spasms. Experts hired by Kristen’s mother said Kristen died because Botox weakened the muscles controlling her breathing and swallowing, leading to respiratory failure and pneumonia. The lawsuit alleged Allergan knew problems had been reported at least two years before her death.

Kristen’s mother also claimed Allergan encouraged Kristen’s doctor to treat CP patients with Botox and helped with his training, According to the LA Times, Kristen’s doctor testified in a deposition that he learned to use Botox on children with CP at Allergan-sponsored seminars in 2000 and 2001, adding that an Allergan sales rep visited his practice 50 times where they discussed treating juvenile CP patients.

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