Allergan Files Federal Lawsuit For Common Therapeutic Off-Label Treatments Of Botox

Allergan has filed a declaratory relief action in the US District Court for the District of Columbia seeking a ruling that would allow Allergan to proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of Botox (onabotulinumtoxinA) for certain ‘off-label’ therapeutic uses.

In the lawsuit, Allergan contends that the Government’s legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act. The lawsuit does not involve Botox Cosmetic.

The FDA has asked for safety updates to the prescribing labels and a Risk Evaluation and Mitigation Strategies (REMS) program for all botulinum toxin products approved in the US, including Botoxd. The safety updates and REMS program require Allergan to speak in general terms about certain off-label uses of Botox.

However, to ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique. Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution.

Douglas Ingram, executive vice president, chief administrative officer and secretary of Allergan, said: “After careful consideration, Allergan filed this lawsuit to enable it to communicate fully with the medical community on off-label, therapeutic uses of Botox to treat patients suffering from serious, debilitating conditions. To serve the objectives of the FDA-mandated REMS program 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.

“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.”

Allergan’s suit does not challenge the Government’s ability to prohibit pharmaceutical sponsors from disseminating false or misleading information about their products. Rather, the lawsuit only seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox. Moreover, far from seeking freedom from regulation, Allergan hopes this suit will lead to clear regulatory guidance on how it can lawfully provide accurate and relevant information on the full range of issues physicians should consider in determining the best therapies for their patients, said the company.