Botox Lawsuit Highlights Another Wrinkle for REMS

While Botox (onabotulinumtoxinA) is best known for its cosmetic use in the temporary smoothing of wrinkles, a large part of the product’s revenue stream for the product — one-third to one-half of its annual $1.3 billion in annual sales, according to some industry estimates — comes from off-label use, for the treatment of neurological and other medical conditions including migraine headaches, upper limb spasticity in stroke victims, lower-limb spasticity in juveniles with cerebral palsy and more.

In developing its mandated REMS program for Botox, Allergan, Inc. (Irvine, CA) is being required by FDA to develop a communication plan that articulates to physicians the safest ways to use Botox. At the same time, existing federal prohibitions on off-label promotion restrict drugmakers’ ability to document off-label use. Withhold key information and you do a potential disservice to physicians who may legitimately choose to prescribe Botox for a growing list of neurological indications. Say too much and you risk the wrath of FDA and the Dept. of Justice.

Critics assert that the federal prohibition on off-label drug promotion is FDA’s equivalent of “Don’t ask, don’t tell,” and that once squared off against rigorous REMS requirements for comprehensive educational disclosure to prescribers, the off-label marketing prohibition creates a set of conflicting objectives. According to industry estimates, roughly 20% of all prescriptions currently written are for off-label indications.

Double jeopardy

Seeking a higher authority to address this apparent contradiction, Allergan filed a lawsuit against FDA in the federal district court in Washington, DC, on October 1. The company contends that unless it can get judicial relief to get the off-label prohibition lifted, its hands are tied when it comes to providing the most comprehensive educational outreach.

“To serve the objectives of REMS for Botox, and to assist physicians in evaluating the benefits and risks of the product, Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of Botox,” said Douglas Ingram, Allergan EVP, in a company statement. “We believe that the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care.” Industry observers say that without judicial relief, Allergan and other drug companies in a similar position are unable to provide truthful and relevant information to practitioners without fear of reprisal from FDA.

“The government is allowing drugs to be used off-label but at the same time is not allowing companies to proactively provide information about it,” says Ingram. “That doesn’t serve public health.”

Allergan and Botox are becoming something of a lightning rod for litigation. Product-liability law firms are opening practices to handle patient complaints; FDA itself has been investigating off-label promotion of the drug already; and lately, a lawsuit has been filed over the single- or multiple-use of the vials in which Allergan sells its product.

For the REMS litigation, industry observers say an outcome that is favorable to Allergan would be a watershed event for its potential to redefine not just REMS requirements, but pharmaceutical marketing in general. At presstime, no details on a hearing date had been announced. PC