Allergan, Inc filed a declaratory relief action in the United States 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. Some of these off-label uses are medically accepted and commonly prescribed but currently unapproved by the United States Food and Drug Administration (FDA). 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.

Under current law, drugs are approved by the FDA for specific uses. Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses. It is estimated that approximately 20 per cent of all prescriptions in the United States are used by physicians for off-labeli indications and are often used to treat very serious conditions such as cancer and AIDS. The FDA has acknowledged the legitimacy and importance of the off-label use of many pharmaceutical products. In fact, federal, state and private health plans routinely pay for many off-label drug uses, including off-label therapeutic uses of Botox for certain types of adult and juvenile spasticity. The FDA and Department of Justice, however, take the position that federal law prohibits pharmaceutical sponsors from proactively providing information to the medical community on off-label uses even when such information is accurate and complete.

This is a particularly significant problem for Allergan today as, effective September 2009, the FDA has required safety updates to the prescribing labels and a Risk Evaluation and Mitigation Strategies (REMS) program for all botulinum toxin products approved in the United States, including Botox. 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.

"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," said Douglas S Ingram, Allergan's executive vice president, chief administrative officer and secretary. "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.

Allergan is represented in its lawsuit by Paul D Clement, a partner at King & Spalding LLP in Washington and formerly the 43rd Solicitor General of the United States.

Botox is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.