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FDA sued over off-label marketing stance

Allergan has filed a lawsuit challenging the FDA's right to prohibit it from providing physicians with information about the off-label use of Botox

The specialty pharmaceuticals company Allergan has filed a lawsuit in the US District Court for the District of Columbia challenging the Food and Drug Administration's (FDA) right to prohibit the company from communicating "truthful and relevant" information to physicians about off-label uses for its botulinum toxin drug, Botox. The US Department of Justice, which works with the FDA on enforcing its regulations, is also named in the suit.

In the short term, Allergan is seeking a preliminary injunction that would allow the company to communicate with physicians about off-label uses without fear of government prosecution, Douglas S Ingram, the company's chief administrative officer and secretary, noted during a conference call with investors. Allergan hopes that the matter will be decided in the next six to 12 months, he added.

In the longer term, the company hopes the suit will lead not to a lack of FDA regulation about off-label promotions, but to a clear set of guidelines on how companies can communicate important information to doctors without violating the law, Ingram noted.

Ingram stressed that Allergan does not currently engage in off-label promotions for Botox, but rather that the suit is forward-looking. "We have strong policies against any promotion of Botox off-label," he said during the conference call. "In fact, one of the reasons that we're filing this lawsuit is because we take compliance very seriously. We do not intend to engage in civil disobedience; we aren't going to do things that are inconsistent with the government's view, which is why we need the court's intervention."

"Even as we conduct extensive clinical trials and obtain new indications for Botox, we can anticipate that it will continue to have a significant number of off-label uses given its mechanism of action," he said. "To exercise their best medical judgment and make informed decisions, physicians benefit from current and truthful information on the risks, benefits and alternatives of treatments, regardless of their on- or off-label use." Such information is particularly important for physician-administered products like Botox, which must be injected using the proper technique, the company states in the lawsuit.

Botox is approved to treat abnormal head position and neck pain associated with cervical dystonia, as well as to treat certain types of eye muscle problems and spasms, and for severe underarm sweating that is not treatable with topical medications. However, Allergan contends that other uses of the drug, including for serious and debilitating conditions such as several types of adult and juvenile spasticity, are “medically accepted and commonly prescribed” even though they lack FDA approval. (Botox Cosmetic, which is approved by the FDA for smoothing frown lines and has made Botox a household name, is not a part of the current suit.)

Allergan argues in the lawsuit that the FDA's stance that pharma companies may not "proactively communicate truthful information to physicians" about off-label indications violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act, which allows physicians to prescribe an FDA-approved drug for uses they deem appropriate whether or not the indication has been approved by the agency.

Allergan said the suit was spurred in large part by the FDA's recent requirement that Botox and other botulinum toxin products be marketed under Risk Evaluation and Mitigation Strategies(REMS).

"The REMS programme for Botox is unusual because it requires communications about certain off-label uses," Ingram explained during the conference call. "If we are to speak about an off-label use and serve the underlying goals of the REMS, Allergan believes we must proactively provide comprehensive information to physicians about these off-label uses, such as dose guidelines, patient selection criteria, injection technique, and the like. However, a proactive dialogue of that nature would place Allergan at an untenably high risk of government enforcement" under the current FDA regulations.

7th October 2009

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