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Allergan sues to share safety information about off-label use of Botox

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IRVINE, Calif. — Allergan has filed a federal lawsuit seeking a court ruling that would allow it to share relevant information with the medical community on the safe use of botulinum toxin A for certain off-label therapeutic uses, the company announced in a press release.

In the suit, "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 release said. "The lawsuit does not involve Botox Cosmetic."

The U.S. Food and Drug Administration has acknowledged the legitimacy and importance of the off-label uses of many products, and many federal and private health plans cover off-label uses for therapeutic Botox. However, the FDA and U.S. Department of Justice "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," the release said.

"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 program for all botulinum toxin products approved in the United States, including Botox," the release said.

Proactive communication of safety information is critical to compliance with the new FDA requirements, according to Allergan.

"Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution," the release said.

The suit does not challenge the government's ability to prohibit pharmaceutical companies from distributing false or misleading information about 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," the release said. "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."