FDA Sued by Allergan Over "Off-Label" Policy


Yesterday, the company who makes BOTOX, Allergan, filed a lawsuit contending that the Government's legal position regarding active marketing to doctors for off-label use violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.

Under current law, the FDA approves drugs for specific uses. While it is legal for physicians to exercise medical judgment for off-label use of an approved drug, the FDA and Department of Justice take the position that federal law prohibits pharmaceutical sponsors from proactively providing information to the medical community on off-label uses.

It has been estimated that approximately 20% of all prescriptions in the United States are used by physicians for off-label indications. This is especially true in serious conditions such as cancer and AIDS. The FDA has acknowledged the importance of the off-label use of many pharmaceutical products. Many federal, state and private health plans routinely pay for off-label drug uses, including off-label therapeutic uses of the non-cosmetic BOTOX (onabotulinumtoxinA) for certain types of adult and juvenile spasticity.


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. The safety updates and REMS program require Allergan to speak in general terms about certain off-label uses of BOTOX. The company feels this new policy will hinder their ability to ensure that physicians are equipped to treat patients as safely and successfully as possible.

The new policy will not allow Allergan to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique.

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(R). 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 Press Release


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