Oregon benefits from Lilly case
Source: Register-Guard, Eugene, Oregon, USA
Oregonis among 32 states and Washington, D.C., receiving a record $62 millionsettlement announced Tuesday from drug maker Eli Lilly & Co. overimproper marketing of an antipsychotic drug.
Oregon Attorney General Hardy Myers, withIllinois Attorney General Lisa Madigan, led the multi-stateinvestigation. He alleged that Lilly improperly marketed the drugZyprexa for uses not approved by the Food and Drug Administration andfailed to adequately disclose the drug’s side effects to health careproviders.
“By now, we hope the entire United States’pharmaceutical industry is on notice that Oregon will not tolerate thedeceptive and unfair marketing and promotion of prescription drugs,”Myers said. “Not only are we securing significant changes in theoperation of these huge drug conglomerates, but we are leading the wayfor our colleagues in the other states and territories to do the same.”
In Eugene, mental health rights activistDavid Oaks hailed the settlement but called for tougher penalties fordrug makers engaging in similar practices.
“Obviously, it’s a victory,” Oaks said.“While the money is great, we would also like in the long run forcriminal penalties to be examined.”
Drug makers have such deep pockets theycan write enormous settlement checks, yet keep marketing their productsinappropriately, he said.
“I hope the money will be used for advocacy to prevent his kind of abuse in the future,” he said.
Zyprexa is the brand name for theprescription drug Olanzapine. The drug was first marketed for use inadults with schizophrenia in 1996. Since then, the FDA has approvedZyprexa for the treatment of acute mixed or manic episodes of bipolar Idisorder and for maintenance treatment of bipolar disorder.
Lilly was accused of marketing the drugfor pediatric care, for use at a high dose and for the treatment ofdementia, according to a statement from the Indiana attorney general’soffice. Doctors are free to prescribe drugs for uses not approved bythe FDA. But drug companies cannot market them for those situations.
The company did not admit wrongdoing in the settlement.
Tuesday’s settlement will be divided amongthe states and the district based on population, said Greg Zoeller,Indiana’s chief deputy attorney general. Indiana will receive $1.6million. Oregon will receive $2.5 million.
Some of the $2.5 million will pay forinvestigative and legal expenses. The balance will go into theDepartment of Justice consumer protection and enforcement fund, whichfinances the vast majority of the state’s consumer protectionactivities.
Lilly also agreed to several mandates thatextend for six years beyond Zyprexa’s patent expiration in 2011. Thecompany agreed to avoid making false, misleading or deceptive claimsabout the drug and not to promote it outside FDA-approved uses.
The drug maker also agreed to give itsmedical staff, not the marketing staff, ultimate responsibility forapproving the content in “all medical letters and medical referencesregarding Zyprexa,” according to the Oregon attorney general’sstatement.
“The one thing that’s really key here is they’ve agreed to have a much more transparent system,” Zoeller said.
However, Lilly spokesman Phil Belt saidmany of the items his company agreed to were things it either alreadydid, or was in the process of doing.
“There’s no admission of wrongdoing, there’s no dramatic changes in the way we’re doing business,” he said.
He said Lilly agreed to the settlement toavoid being wrapped up in litigation and other things it deemscounterproductive to drug development.
“We think its better for Lilly, better for patients, better for prescribers to have this kind of activity behind us,” he said.
Lilly said it will take a related charge of 4 cents per share in the third quarter for the settlement.
Zyprexa rang up $4.8 billion in sales lastyear. But Lilly also has settled more than 31,000 product liabilityclaims against the drug since 2005, shelling out more than $1.1 billionin the process.
Last year, Lilly paid $15 million to settle a lawsuit with the state of Alaska in March.
# # #
original article: http://www.registerguard.com/web/search/546519//story.csp