The First Amendment of the United States Constitution protects the freedom of speech. Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury. So-called “commercial speech” is a category of speech afforded partial, but not total, protection by the country’s courts. Regarding the First Amendment debate, the FDA faces a conflict: to balance the need for neutral and candid research within the medical community concerning off-label uses against the self interest of drug makers, who stand to profit if their drugs may be sold for more medical conditions. Continue reading
AstraZeneca recently settled federal investigations regarding its marketing practices of Seroquel for $520 million. Although Seroquel had only been approved by the FDA to treat schizophrenia and acute bipolar I disorder, whistleblower James Wetta accused the company of embarking on a national sales program to promote Seroquel for off-label use by the elderly, children and prisoners. According to the complaint, AstraZeneca disseminated false information to child and adolescent psychiatrists, primary care physicians, and elderly patients suffering from age related dementia. Among the off-label marketing tactics alleged by Wetta was sponsorship of “continuing medical education” seminars, which doctors must enroll in to keep their medical license. Continue reading
The U.S. Food and Drug Administration (FDA) has issued a letter to drug maker Novartis warning it to cease its incomplete and misleading promotion of the leukemia fighting drug Tasigna on Facebook. Novartis had been using Facebook’s “share button” to market the drug on the social website giant. However, in violation of federal laws, the advertisements failed to include the risks associated with taking the drug. Additionally, despite the fact that clinical trials have not shown the drug to be more effective than its competitors, the Facebook advertisement promoted the drug as superior to other products – again in violation of federal law. Continue reading
A multi-state agreement was reached between 49 states, the District of Columbia, and Alpharma Inc. on June 8 to settle allegations of kickbacks and off-label promotion of its drug, Kadian. A whistleblower receiving $5.33 million of the total $42.5 million settlement initially filed the lawsuit in 2006 under the False Claims Act.
Between January 2000 and December 2008, Alpharma allegedly paid kickbacks to doctors to encourage them to prescribe Kadian or both approved and off-label uses. Continue reading
Pharmaceutical company Elan Corporation recently announced an agreement with the DOJ to pay $203.5 million to settle Medicaid fraud claims involving its previously divested antiepileptic drug, Zonegran. As a result of the agreement, Elan pled guilty to a misdemeanor violation of the Food Drug and Cosmetics Act (FDCA) and plans to enter into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. Continue reading