Allergan’s complaint argues that the Food, Drug, & Cosmetic Act does not prohibit the prescription or administration of off-label uses of legal drugs, and that such off-label uses are in fact quite common. The complaint alleges that “on its face,” the Act permits a manufacturer to “speak freely to health care professionals about an off-label use of a prescription drug,” so long as it does not “proscribe, recommend, or suggest” the off-label use or render the labeling “false or misleading.” The complaint alleges that the FDA, however, has expansively interpreted the terms “labeling” and “suggest” to prohibit any communication by the manufacturer regarding an off-label use of the drug. The complaint asserts that such a prohibition of truthful speech violates the First Amendment.
The complaint further alleges that manufacturers are presented with a “catch-22” if off-label uses become common. In that event, the complaint argues, the manufacturer, merely by becoming aware of the off-label use, is obligated to provide “adequate directions” for use under the FDA’s regulations. But by doing so, it violates the FDA regulations against improper “labeling.”
Allergan’s complaint alleges that in particular, Botox, which is approved for treatment of certain types of involuntary muscle movements, has been commonly used off-label for other types of spasms (the cosmetic form of Botox is not at issue in the suit). Allergan proposes in its complaint to provide information to doctors (but not consumers) about proper use of the medication for these treatments in a way that maximizes the benefits while minimizing the risks, but it “fears” that its “planned truthful, non-misleading scientific speech to physicians” would lead to “criminal prosecution and severe civil penalties.”
Allergan additionally asserts that the FDA regulations may affect the filing of civil complaints, arguing that “even by filing this complaint and exercising its First Amendment right to petition the Government,” Allergan might “run afoul of the FDA’s regulatory scheme by demonstrating its knowledge that Botox is sold to physicians who use it to treat” the off-label conditions.
Allergan has moved for a preliminary injunction to prevent the FDA from applying its regulation interpreting the Food, Drug, & Cosmetic Act. A hearing on the motion has been set for March 2, 2010.
