Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses

The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process.

Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that the FDA’s ban on “off-label” drug promotion by pharmaceutical companies violates their first amendment rights to free speech. The ban restricts Allergan from offering information about off-label use of Botox, an antiwrinkle drug that is used by many doctors for unapproved uses, such as treatment of muscle spaticity in children with cerebral palsy.

Although doctors are allowed to prescribe medications for non-approved uses, drug makers are prohibited from marketing those applications. Allergan says that the ban is unconstitutional and prevents them from offering truthful information and other data that could help doctors prescribe the drugs effectively and safely.

Botox contains extremely minute quantities of Botulinum Toxin A, which causes muscle paralysis. Although the medication is most commonly known for its cosmetic uses to remove wrinkles, it is also approved treat cervical dystonia, spasms of the eyelids and symptoms of severe underarm sweating.

One of the most common off-label Botox uses is among children with cerebral palsy, who are given much larger doses of the drug. The toxin is used to prevent muscles from involuntarily contracting, helping alleviate stiff, jerky and difficult movements commonly associated with cerebral palsy.

Earlier this year, the FDA required a black box warning for Botox about the risk of serious injury or death if the drug spreads from the area of the injection to other parts of the body. The warning was issued after the FDA received a number of reports of Botox problems, most commonly involving off-label use at higher doses.

Allergan claims that they should be permitted to provide doctors with dosing guidelines and instructions on injection techniques that could help reduce the risk associated with Botox off-label use and improve patient safety.

The effect of a successful overturn of the FDA ban on drug companies marketing off-label uses of their products could have far reaching effects. According to a 2006 study in the Archives of Internal Medicine, more than 20% of all drug prescriptions in the United States are already off-label, and this number could increase dramatically if drug companies are allowed to promote information about unapproved use.

Despite the ban, which has been in effect since 1938, many pharmaceutical companies have been accused of promoting drugs off-label, which can substantially increase sales. Last month, Pfizer agreed to pay $2.3 billion in fines to resolve claims that they promoted the recalled painkiller Bextra for unapproved uses. Government prosecutors said that Pfizer marketed Bextra for uses that would require larger doses even after learning that the health risks of the drug increased with dosage.

Last week, Eli Lilly & Co. agreed to pay $25.1 million to the state of Connecticut, on top of more than $1.4 billion in fines that were part of a January settlement over off-label promotion and hiding side effects associated with their antipsychotic drug Zyprexa.

AstraZeneca also faces allegations of off-label promotion for its antipsychotic drug Seroquel in lawsuits filed by nearly 20,000 plaintiffs who claim the drug maker failed to adequately warn about potential side effects of Seroquel that may increase the risk of diabetes, weight gain, hyperglycemia and a rare movement disorder known as tardive dyskinesia.