Allergan Files "Free-Speech" Complaint Against Govt

Last week, Allergan, maker of Botox (onabotulinumtoxinA), announced a suit against the US government, seeking "declaratory relief" from such long-time federally mandated off-label speech restrictions.* The complaint, filed in US District Court for the District of Columbia, specifically applies to the sharing of information about Botox Therapeutic (not Botox Cosmetic) and recent requirements of the FDA's Risk Evaluation and Mitigation Strategies (REMS) program. In its complaint, the company is represented by Paul Clement, former Solicitor General and a current partner in the DC law firm of King & Spalding.

Allergan's suit was filed with respect to the FDA's REMS program for botulinum toxin products. The program was instituted this year because of postmarketing reports of toxin spread after injections for off-label conditions—namely, spasticity in children with cerebral palsy and arm spasticity in adults. In the program, the FDA requires manufacturers to create a "communication plan" that provides information to physicians about the risk of the distant spread of botulinum toxin after local injection.

But Allergan argues that the FDA's required communication plan puts the company in a double bind—effectively mandating proactive discussions about the safety of off-label Botox Therapeutic, while simultaneously prohibiting proactive off-label discussions. Allergan claims that it cannot reasonably abide by the FDA's REMS program for Botox Therapeutic (ie, "proactively provide comprehensive information to physicians about these off-label uses [emphasis added]") without fear of prosecution. The company writes, "Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of [Botox]."

In a conference call on Friday, Allergan's General Counsel, Douglas Ingram, provided additional information about the complaint and fielded questions. Ingram stressed that the company's suit applies to the provision of "truthful," "nonmisleading," and "comprehensive" information about the off-label uses of Botox Therapeutic. Ingram would not comment on a recent investigation of the company by the US Attorney's Office for the Northern District of Georgia, which issued a subpoena in March to the California-based firm regarding the alleged off-label promotion of Botox for headache. Both Ingram and Allergan CEO, David Pyott, stressed that the company's current complaint does not relate to alleged past activities. Ingram also declined to comment on Pfizer's recent record-breaking $2.3-billion settlement with the government concerning off-label drug promotion.

* Mandated by the Federal Food, Drug, and Cosmetic Act of 1938. The FDCA dictates that an approved drug is "misbranded," if it is marketed (in interstate commerce) for an unapproved use. The act stipulates that the product's approved label, in this case, does not provide "adequate directions for use."