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Botox Maker Sues to Have Off-Label Marketing Rules Lifted

Oct 2, 2009 | Parker Waichman Alonso LLP

Allergan Inc. is claiming that rules forbidding it from distributing information about the off-label use of Botox wrinkle treatment and other drugs are a violation of its First Amendment right to free speech.  According to The  Wall Street Journal, the drug maker has filed suit against the Food & Drug Administration (FDA) over the restrictions.

Using a drug in a way that has not been approved by the FDA is known as off-label use.  As we've reported in the past, doctors are free to prescribe off-label, but the Food, Drug and Cosmetic Act of 1938 prohibits drug makers from promoting such uses.  According to The Wall Street Journal, they may provide doctors with accurate information about off-label uses - such as scientific studies - if a doctor requests such material.

Critics of off-label promotion say such marketing practices are harmful, as the vast majority of off-label uses have not been subjected to enough scientific scrutiny to ensure their safety.  Even so, off-label prescribing is common.  According to The Wall Street Journal, a 2006 study in the Archives of Internal Medicine found that 21% of drug use is off-label.

When drug makers do promote off-label uses, they can get in a lot of trouble.  For example, last month we reported that Pfizer had agreed to a $2.3 billion settlement with the U.S.  Department of Justice  to resolve allegations that it had illegally marketed several drugs including the antipsychotic Geodone, the pain killer Bextra; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug.  That agreement marked the largest healthcare fraud settlement in the history of the U.S. Department of Justice.

Allergan's Botox is approved to treat facial wrinkles,  eye muscle disorders and excessive underarm sweating.   According to Reuters, Allergan is currently testing Botox for a variety of uses including treatment for upper limb spasticity in stroke victims as well as for migraine headaches.

In April, the FDA mandated a boxed warning for  Botox and other botulinum toxin injection treatments regarding the risk of adverse events when the effects of  the drugs spread beyond the injection site. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for muscle-spasm conditions, an off-label use.

In a statement, the company said the FDA's ban on off-label promotion was particularly difficult since the agency had required the Botox safety update. "To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique," the company's statement said. "Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution."

Reuters is reporting that Allergan has also maintained that its lawsuit against the FDA is not in response to a federal investigation into Botox marketing that was launched by federal prosecutors last year.