Drugmaker Wants FDA to Can Limits on Drugs' 'Off-Label' Promotion

Drugmaker Allergan Inc. has sued the Food and Drug Administration, alleging the agency's expanding drug labeling rules unconstitutionally bar it from telling physicians about its products' "off-label" uses.

In a declaratory judgment action filed in the U.S. District Court for the District of Columbia, the firm says it fears criminal prosecution and hefty monetary penalties for giving doctors truthful information regarding the discretionary use of certain products because of the FDA's recent regulatory crackdown on the promotion of drugs' "off-label" uses.

While the Food, Drug & Cosmetic Act does not interfere with a physicians' individual discretion to prescribe drugs for unapproved purposes (and about one-fifth of prescription-drug use falls into that category), the FDA recently has "promulgated a series of overlapping and interlocking regulations that combine to render unlawful virtually all manufacturer communication, through any avenue, to any audience, about the lawful, off-label use of a prescription drug," the complaint says.

California-based Allergan says the regulatory stance prevents drugmakers from providing data about the safe and effective use of FDA-approved drugs for off-label uses and "even prohibits a manufacturer from informing medical professionals who already used a drug off-label how to minimize the risk of rare but serious adverse events."

Allergan's arguments concern its product Botox (onabotulinumtoxinA), an injectible medication that is FDA-approved for the treatment of eyelid spasms, crossed eyes and involuntary neck muscle contractions. The drug, however, also is commonly used to reduce spasticity in adult stroke patients and limit lower-limb spasticity in children with cerebral palsy.

The lawsuit does not involve Allergan's sister product, Botox Cosmetic, which is used to reduce wrinkles for personal appearance.

The company seeks a declaratory judgment that the FDCA does not bar drug companies from engaging in "truthful and non-misleading speech about off-label uses" or including similar language in their drugs' labeling.

Allergan says it wants U.S. District Judge John D. Bates' clarification on the matter, given the FDA's recent position that the FDA-approved definition of "labeling" encompasses not only the containers and wrappers accompanying a drug, but also any "brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs" and associated printed or visual matter use to promote it.

The company says it also was prompted to seek a declaratory judgment because of the FDA's successful actions against drugmakers over off-label product promotions, such as the agency's recent $1.4 billion settlement with Eli Lilly & Co. regarding charges that the company aggressively promoted its drug Zyprexa for unapproved purposes.

In a media statement released with the filing of the lawsuit, Allergan stressed that it does not seek to challenge the FDA's authority to keep drugmakers from using "false or misleading information about their products," but only the right to "proactively provide the medical community with truthful, important information about common, off-label uses of Botox."

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Representing Allergan are Paul Clement, Zachary Tripp and Matthew Lash of King & Spalding in Washington.