Allergan Suing U.s. to Void Rules, Market Off-label Botox Uses
The company will seek a court order allowing it to give doctors information about uses for Botox that havent been approved by the U.S. Food and Drug Administration, Allergan said in a statement distributed yesterday. U.S. rules that make it a crime for drugmakers to promote medicines for unapproved uses contravene the First Amendment of the U.S. Constitution and the federal Food, Drug and Cosmetics Act, according to the statement.
While doctors are free to prescribe any drug to treat illnesses regardless of FDA approvals, pharmaceutical companies are prohibited from promoting medicines for off-label uses. A copy of the complaint, to be filed in federal court in Washington, names the FDA and the Justice Department as defendants, said Caroline Van Hove, an Allergan spokeswoman.
Botox, a purified form of the deadly poison botulinum, paralyzes muscles and nerves and is used to relax wrinkles and treat neurological disorders.
Almost 2.5 million Americans had Botox injections last year for cosmetic purposes, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It became fashionable among aging celebrities as a nonsurgical way to appear younger.
Safety Updates
The FDA has required safety updates on labels for all botulinum toxin products, including Botox, to beef up warnings about side affects such botulism poisoning and muscle weakness. Most side affects have been reported following treatment of arm and leg spasms, a use not approved by the FDA, and a neck- twisting disorder.
Allergan should be allowed to proactively provide dosing guidelines, injection techniques and other information to doctors about these off-label uses, according to the companys statement.
The FDA declined to approve the use of Botox by patients who have suffered a stroke, pending the completion of a safety plan, the company said in May.
Tracy Schmaler, a Justice Department spokeswoman, had no immediate comment. Karen Riley, an FDA spokeswoman, didnt immediately respond to a voice-mail message left after regular business hours.
Botox accounted for almost a third of Allergans revenue last year with $1.3 billion in sales, split between cosmetic and therapeutic uses.
Eli Lilly & Co., the largest maker of psychiatric drugs, agreed to pay $1.42 billion in January to resolve a Justice Department investigation into off-label marketing of Zyprexa, its best selling drug.