Allergan and Botox or FDA: Who Has the Last Word?

September 30th, 2010. By janem

As you may know, Allergan Inc. recently pled guilty to off-label promotion of its product Botox and dished out $600 million to resolve its criminal and civil liability suits. Allergan apparently made it a top corporate priority to maximize sales of Botox for headaches, pain, spasticity and juvenile cerebral palsy from 2000 to 2005—the time the FDA hadn’t approved Botox for marketing. Oh yeah, and Botox wasn’t approved to treat wrinkles either. So what was it approved for?

In 1989, Botox was FDA-approved to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction). In 2000 and 2004, it was approved to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating). Then in 2010, approval was given to treat adult upper-limb spasticity. That’s it.

But greed got the better of Allergan and it concocted a plan in 2003 to tap into the headache and pain market: It came up with the “CD/HA Initiative” (CD standing for on-label cervical dystonia) as a “rescue strategy”, it claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.” So the FDA steps in and justice is served.

The civil penalties will be divided between federal and state health plans that were billed for unapproved uses of Botox, and five whistle-blowers who filed lawsuits in Georgia under the False Claims Act.

EXCEPT that Allergan seems to get the last word in:  As part of the agreement, the company was required to drop its lawsuit filed against the FDA in October challenging a government rule that prohibits companies from marketing “off-label” promotions, i.e., unapproved uses.

“This is a good outcome that protects the American people,” said the FDA Commissioner. “The off-label promotion of drugs threatens public health and the regulatory framework of the FDA.”

HUH? Why did the FDA make a deal to drop Allergan’s off-label promotions suit—is the agency that unsure of its legal position,  or does Allergan have deeper legal pockets? Or?? Curious minds would sure like to know…

Tags: Allergan, Botox, Off-label

This was posted on Thursday, September 30th, 2010 at 5:20 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.