It happens with smartphones, social networks and even designer handbags. But it is not supposed to happen with prescription drugs marketed to doctors, according to federal law.
That is the charge leveled againstAllergan, the maker ofBotox, in a phalanx of false-claims lawsuits and federal inquiries that resulted last week in the company’sagreeing to pay $600 million to resolve criminal and civil complaints of illegal marketing tactics.Allergan also agreed to plead guilty to one misdemeanor chargeof misbranding Botox from 2000 through 2005, but the company denied the other allegations.
Allergan’s settlementwith the Justice Department resolves the latest crackdown by the federal government against major drug makers. Last year,PfizerandEli Lillypaid hefty sums to resolve federal charges of illegal marketing.
The lengthy federal investigation of Allergan tracked the rise of Botox in an ever-expanding market. Over the last decade, Botox has gained fame— and talk show notoriety— as a wrinkle killer. Along the way, the drug has become a blockbuster brand, with worldwide sales last year of about $1.3 billion, in no small part because it can also be used to treat a variety of muscle and gland disorders.
TheFood and Drug Administrationhas over time approved the injections to mitigate uncontrolled blinking, certain neck muscle spasms, excessive underarmsweating, andwrinklesbetween the eyebrows. This year, the agency again expanded the use of Botox, permitting injections for increasedmuscle stiffnessin the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.
Meanwhile, Allergan is currently studying Botox as a treatment for overactive bladders, and owns patents on dozens of other potential Botox treatments.
The company denies most of the complaints in lawsuits by whistle-blowers and federal prosecutors. But documents released by the Justice Department related to the settlement outlined claims that Allergan had systematically built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, pain, muscle spasticity andcerebral palsyin children.
Doctors are allowed to prescribe drugs in unapproved ways as they deem medically appropriate, but it is illegal for a drug maker to promote those unapproved, or off-label, uses. Court filings have described an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as aheadachetreatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors; and paid kickbacks to doctors to induce them to prescribe Botox.
“What concerns F.D.A. is that, if companies can promote off-label uses without submitting evidence showing the drug to be safe and effective, it potentially puts patients at risk and subverts the drug approval system,” Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said in a phone interview about the case on Tuesday.
Without an independent determination by agency experts on the optimal doses and precautions for a particular drug treatment, he said, doctors can wind up prescribing medications without good evidence.
Except for the one misbranding charge, Allergan has denied the criminal and civil accusations, including those of kickbacks and fraud, said Caroline Van Hove, a company spokeswoman, adding that the allegations were not proved.
“I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm,” Ms. Van Hove wrote in an e-mail to a reporter on Monday,“and we adamantly deny any implication that this occurred.”
Allergan, she added, has spent hundreds of millions of dollars in medical research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she said. Several drug makers finance the Neurotoxin Institute, an independent scientific group, she added.
The settlement agreement comes at a delicate moment for the potentially vast new use of Botox to prevent chronic migraines, a debilitating condition. The agency is expected to decide by the end of October on Allergan’s application for that use, which was submitted just last year.
Even so, according to evidence in a separate product liability lawsuit, Botox headache shots already had sales in the United States of nearly $56 million in 2007, signaling growing use for that treatment.
Ms. Van Hove of Allergan said the company had not promoted Botox for migraines, but it had communicated appropriate scientific information about studies on that use.
If the F.D.A. approves the headache shots, she added, the treatment will“address a significant and outstanding need in the treatment of chronicmigrainethat cannot be dismissed or discredited as a result of this settlement.”
Dr. Sharfstein of the F.D.A. said the Allergan settlement for off-label marketing would not influence the agency’s scientific review of the migraine application.“I think the approval should follow the evidence,” he said.
Millions of dollars are indeed at stake for Allergan.
The British medicines agency recently approved Botoxas a migraine treatment. If the F.D.A. were to follow Britain’s lead, some Wall Street analysts have estimated that sales of the drug for migraines could reach $1 billion or more annually worldwide by 2016.
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