Allergan takes legal action against US govt over right to share info with physicians on Botox

California, USA-based Allergan says it has filed a declaratory relief action in the US District Court for the District of Columbia seeking a ruling that would allow the firm 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.

Botox is approved for several uses by the US Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. However, physicians often use it for unapproved indications including muscle-spasm conditions.

In the law suit, Allergan contends that the US 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 law suit does not involve Botox Cosmetic.

Under current law, drugs are approved by the FDA for specific uses. Once a drug is cleared, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses. It is estimated that approximately 20% of all prescriptions in the USA are used by physicians for off-label 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. 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, says the company, 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 USA, including Botox. The safety updates and REMS program require the company to speak in general terms about certain off-label uses of its product. 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, it claims.

Allergan's suit does not challenge the government's ability to prohibit pharmaceutical sponsors from disseminating false or misleading information about their products. Rather, it 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 says it 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.