Allergan agrees to pay $600 million for illegally promoting "off-label" use of Botox for conditions such as juvenile cerebral palsy

From MoneyLife:

Allergan has pleaded guilty for its “off-label” promotion of Botox and has agreed to pay $600 million to settle charges in a longstanding federal investigation. But the Botox maker maintains that the drug is safe and says many people have taken it with no problems.

Allergan Inc, a multi-specialty healthcare company, has agreed to pay $600 million to settle federal charges for “illegally promoting and selling” Botox through 2005 for “unapproved uses” like treating headaches.

According to ConsumerAffairs.com, the US Food and Drug Administration (FDA) had approved Botox only for use in rare conditions but the company had vigorously promoted it for “off-label uses”, including relief from headaches, pain, spasticity and juvenile cerebral palsy. Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication.

US attorney Sally Yates has been quoted as saying that Allergan made it a top corporate priority to maximise sales of far more lucrative off-label uses that were not approved by the FDA. Yates further says, “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.”

Botox is designed to block nerve impulses to certain muscles, causing them to relax. The product is approved to treat uncontrolled muscle contractions of the neck and shoulder muscles. Botox is also approved for cosmetic use to treat wrinkles between the eyebrows and to help control excessive underarm sweating.

In some cases, the toxic, active ingredient in Botox — a derivative of botulism toxin Type A, one of the deadliest poisons known — can affect respiratory muscles and cause difficulty in swallowing, a condition known as dysphagia. The product warns doctors and consumers of that side effect.

The FDA said that it appears the active ingredient in Botox can spread from distant parts of the body — such as children’s leg muscles — to muscles that affect breathing.

The company, based in Irvine, California, was named in both civil and criminal complaints filed in the US District Court in Atlanta.

Allergan, on its website, has agreed to plead guilty to a single misdemeanor
“misbranding” charge covering the period 2000 through 2005 and pay to the government $375 million. This misbranding charge is known as a strict liability offence. A prescription drug is considered misbranded when its labelling does not contain adequate directions for its “intended uses”.

In addition, Allergan has agreed to pay $225 million to resolve civil claims asserted by the US Department of Justice under the civil False Claims Act. The civil settlement is an element of a global settlement that Allergan believes is in the best interest of its stockholders.

The Botox maker said, “As part of its plea, Allergan has agreed that between 2000 through 2005, its marketing of Botox resulted in intended uses for the therapeutic treatment of headache, pain, spasticity and juvenile cerebral palsy. These uses were off-label during the relevant time frame and thus the labelling for Botox did not bear directions for these intended uses, resulting in the product being misbranded.”

In March 2010, the US FDA approved Botox for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper-limb spasticity. The label now included directions for that use, it added.

Allergan denies liability associated with these civil allegations and does not believe there is merit in them factually or legally, said the company in a statement.

However, if one glances through ConsumerAffairs.com, a series of cases have been mentioned against the company. The sites states that Botox users are pursuing a class action lawsuit against Allergan, claiming the company failed to adequately warn users of the drug’s dangers. The suit, filed in July 2008, claims the toxin-based drug killed at least three people, including a seven-year-old girl with cerebral palsy who got Botox injections to help control spasticity in her limbs.

The US FDA said in February that Botox was being injected at an alarming rate among children, especially those who are being treated for limb spasticity associated with cerebral palsy.

It noted that neither Botox nor a similar product, Myobloc, was approved for such use in the US and said there have been deaths associated with the usage of the two treatments among children.

The FDA said in February 2008 that it knew of no deaths among adults but the class action, filed in California's Orange County Superior Court, said a 69-year-old Texas nurse and a 71-year-old woman both died after receiving Botox injections.

The nurse had been receiving injections for neck and shoulder pain, while the 71-year-old, who lived in Arizona, was taking Botox at a mall clinic for wrinkles around her mouth. The suit says she had trouble breathing and swallowing after the treatment and died a short time later.

All three of the cases involved uses of Botox that are not approved by the US FDA.The suit also charges that Botox left at least 12 other patients with a range of disabilities, including some who were taking the drug for approved uses, such as smoothing frown lines.