Drugs are approved by the United States Food and Drug Administration for specific uses, but doctors are allowed to use their judgment to prescribe them for off-label uses, meaning, to treat illnesses other than the ones the FDA has approved the drug for. Pharmaceutical companies, however, are not allowed to promote such off-label uses.In fact, it was just a month ago that Pfizer Inc. (PFE) paid a record fine of $2.3 billion to settle civil and criminal charges for promoting off-label uses for its recalled Bextra arthritis drug and three other medicines. Earlier this year, Eli Lilly (LLY) agreed to pay $1.42 billion for off-label promotions of its Zyprexa schizophrenia drug.
The ban on off-label promotion stems from a law, The Food, Drug and Cosmetic Act of 1938, intended to protect consumers from bogus and potentially harmful products. But the ban, Allergan contends, can be more harmful than helpful as it prevents important information on off-label uses from reaching doctors and is therefore inconsistent with the intention of the Act. The ban, Allergan says, also violates its First Amendment right to free speech.
The Irvine, California-based company says -- and a study published in the Archives of Internal Medicine in 2006 agrees -- that it is estimated that approximately 20 percent of all prescriptions in the U.S. are used by physicians for off-label indications and are often used to treat very serious conditions such as cancer and AIDS. Not only that, but federal, state and private health plans routinely pay for many off-label drug uses.These, Allergan says, include off-label therapeutic uses of Botox for certain types of adult and juvenile spasticity.
Doctors can prescribe the drugs, but under the current rules, Allergan is not allowed to provide "accurate and complete" information on these off-label uses, including dosing guidelines, patient selection criteria and proper injection techniques. Caroline Van Hove, VP of Corporate Communications told DailyFinance Allergan finds it particularly difficult to adhere to the FDA's recent requirements to initiate REMS (Risk Evaluation and Mitigation Strategies) on Botox to prevent botulism poisoning and muscle weakness as well as other serious side affects when it can't provide comprehensive information to physicians for fear of prosecution. Most side effects, it notes, have been reported following treatment for uses not approved by the FDA.
Allergan is therefore seeking a ruling that would allow it to "proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of Botox for certain 'off-label' therapeutic uses. Some of these off-label uses are medically accepted and commonly prescribed but currently unapproved by the United States Food and Drug Administration."
While this lawsuit may not amount to much (attempts to reach the FDA were not immediately answered), it may highlight some problems arising from older laws. The U.S. government, through its agencies, needs to find a way to reconcile the need to protect the public from snake oil sellers, while allowing for the best practices to help patients. Of course, the question is whether Allergan's motives really are that pure or does it simply want a green light to actively promote off-label uses, as many other pharmas have done, rather than just provide important information on such uses to physicians who require it.
In September, a study showed Botox can help prevent migraine headaches, a use that if approved could be worth a potential $1 billion in added sales yearly. As it its, Botox accounted for almost a third of Allergan's revenue last year with $1.3 billion in sales, split between cosmetic and therapeutic uses. Botox also faces a challenge from Dysport, a drug made by Medicis Pharmaceutical Corp (MRX) and Ipsen.
Botox contains tiny amounts of a highly purified form of the deadly poison botulinum, which paralyzes muscles and nerves and is used to relax wrinkles and treat neurological disorders. Nearly 2.5 million Americans had Botox injections last year for cosmetic purposes, according to the American Society for Aesthetic Plastic Surgery. The drug was first approved in 1991 for medical uses and in 2002 as a wrinkle smoother, but is still awaiting approval for other uses.