WASHINGTON—The maker of a widely used women's osteoporosis drug has agreed to plead guilty to illegally pushing the drug for such "off-label" uses as the prevention of breast cancer.
In a criminal and civil settlement announced Wednesday by the Department of Justice, Eli Lilly and Co. agreed to plead guilty to a criminal misdemeanor count of violating federal drug laws through its promotion of Evista, a blockbuster drug with 2004 worldwide sales of just over $1 billion.
In addition to the criminal plea, Lilly agreed to pay $36 million in criminal and civil fines and other penalties and enter into a wide-ranging consent decree to prevent improper marketing.
In a statement, Lilly's chairman and chief executive, Sidney Taurel, said "we deeply regret" the improper marketing conduct. While the company says it doesn't agree with all the government's allegations, it agreed to settle the dispute to close the matter.
The Food and Drug Administration approves drugs to treat specific illnesses in certain people. Drugmakers are allowed to market drugs only for those approved uses.
Doctors, however, are free to prescribe drugs as they see fit—even if they're for off-label, or unapproved, uses. And while some off-label uses are beneficial and based on good science, others have little proof of effectiveness behind them. As a result, consumers often take on risks inherent with any prescription drug with little or no assurance that the drug could help them.
A 2003 series in Knight Ridder newspapers detailed the rapid growth of off-label prescriptions and showed how drugmakers were increasingly relying on off-label sales to boost profits. Among the drugs featured in that series was Evista, which internal Lilly documents reviewed by Knight Ridder showed was being pushed for the prevention of breast cancer. The drug is approved only for the prevention and treatment of osteoporosis in women after menopause.
According to the Justice Department and its Office of Consumer Litigation, which handled the case announced Wednesday, Lilly's illegal conduct arose as the company tried to maximize Evista's sales. The issue is important, the Justice Department said, because without the "benefit of careful FDA oversight," off-label promotions can harm consumers.
In this case, it meant that patients worried about getting breast cancer might take Evista instead of a drug that has been proven in clinical trials to prevent breast cancer.
Lilly says it's conducting clinical studies to determine whether Evista can reduce the risk of breast cancer. It will be at least a year, however, before the results of those studies are submitted to the FDA for review, a spokesman said.
In expansive documents released along with the settlement, the Justice Department said Lilly was initially disappointed by Evista's lackluster sales in 1998, when the drug was launched.
Then, "in order to expand sales of the drug, Lilly sought to broaden the market for Evista by promoting it for unapproved uses."
In 1998, Lilly promoted unapproved uses for Evista, including touting it to prevent or reduce the risk of breast cancer and to reduce the risk of heart disease, the Justice Department said.
Lilly sales representatives were "encouraged" to send unsolicited letters to doctors on their routes to promote off-label uses, and they were "trained to prompt or bait questions by doctors in order to promote" off-label uses.
Marketing research surveys indicated that doctors said they were told by Lilly sales representatives that Evista may reduce the risk of breast cancer. The settlement information also lists sales calls in several states—Illinois, Texas, California and Alabama, among others—in which Lilly representatives pushed Evista for off-label uses.
The settlement is subject to approval by the federal court in Indianapolis, where Lilly is based.
The Justice Department is continuing to investigate companies for improper off-label promotions. In 2004, Pfizer Inc. agreed to pay $430 million for the off-label marketing of its epilepsy drug Neurontin; that case stemmed from actions by Warner-Lambert Co. employees before Pfizer bought the company.
In October of this year, Serono S.A. agreed to pay $704 million for its improper promotion and marketing of an AIDS-wasting drug called Serostim.
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To read the government's documents filed in this case, go to:
www.usdoj.gov/civil/ocl/cases/Lilly/index.htm.
To read Knight Ridder's series on off-label prescribing, go to:
http://www.realcities.com/mld/krwashington/news/special_packages/riskyrx/.
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(c) 2005, Knight Ridder/Tribune Information Services.
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