In a new twist on "direct mail campaigns," marketers at Eli Lilly have taken DTC to an unprecedented level. The company is currently under investigation by the Florida attorney general for allegedly mailing Prozac Weekly (fluoxetine) to a woman who did not have, or request, a prescription for the product. The investigation stems from a privacy invasion lawsuit that the Florida resident filed against Lilly, Walgreens, a local hospital, and several doctors-for misusing her medical history and engaging in the unlawful practice of medicine.

The woman had apparently taken antidepressants in the past and that information was in her records. According to a report in the Chicago Tribune, the letter accompanying the product said, "Enclosed you will find a free one-month trial of Prozac Weekly. If you wish to try Prozac Weekly, stop your daily antidepressant one day before starting Prozac Weekly, then take only Prozac Weekly once a week thereafter. Congratulations on being one step to full recovery."

Privacy and ethical considerations aside, direct distribution of pharmaceuticals to consumers is illegal under both Florida state law and the federal Food, Drug, and Cosmetic Act, according to Brian Waldman, an attorney with the Food & Drug Group of Arent Fox. Complicating the issue are the doctors who allegedly wrote the prescription and the participation of Walgreens, the pharmacy that filled and mailed it. "It clearly smacks of a sham," Waldman adds. "The fact that the patients aren't consulting their physicians and requesting the medication, there may be some medical malpractice issues here." That is another facet the investigation must determine: Was the sample product sent as marketing material or medical advice?

"Although Lilly supports informing people about new treatment options and encouraging them to discuss these options with their doctor, what occurred in Florida went beyond that. It is inappropriate and inconsistent with corporate policy for Lilly sales personnel to support programs in which medicine is mailed to patients without the patient's request. We take any allegation involving privacy very seriously."

The district attorney's office is also investigating how many Florida residents received the Prozac samples and whether other pharmacies were involved. The case highlights recent privacy lawsuits that patients have filed against manufacturers and pharmacies for using medical and consumer records as a database for compliance reminder mailings. By stepping over the line and sending actual products, a few marketers may inspire regulators to tighten privacy and direct mail regulations for the entire industry.