Floridian Sues Over Free Prozac Sample Sent Through Mail

WASHINGTON -- A Florida woman opened her mailbox last month to find a free box of once-a-week Prozac from her pharmacy chain--astonishing, she says, since she didn’t use Prozac and hadn’t asked her doctor to switch her from another antidepressant.

It’s not clear how many other patients received unsolicited Prozac (the woman’s attorneys say they know of two more so far) or whether the apparent campaign to sign up new Prozac customers extended beyond South Florida.

Prozac maker Eli Lilly & Co. issued an apology for the incident late Wednesday and said it is investigating. The Food and Drug Administration is watching closely.

The Prozac mailings may mark the first time a powerful prescription drug had been sent to patients neither expecting nor wanting new pills, an apparent twist on marketing campaigns to persuade patients to switch medications.

“I’m incredulous,” said drug safety expert Michael Cohen of the nonprofit Institute for Safe Medication Practices, who called the mailings dangerous. “You might have [people] other than the patient picking it up out of the mailbox and taking it. It could be a child.”

The big question: Is mailing patients unsolicited prescription drugs, as if they were detergent samples, legal?

Laws governing prescription-writing and pharmacy practices vary by state. The drugstore chain Walgreens maintains it properly filled prescriptions from doctors’ offices and mailed them free because it had “coupons” from Lilly to provide reimbursement. The Florida woman’s doctors aren’t talking.

Lilly issued a statement late Wednesday saying it was inappropriate to mail medicine to patients without their request.

“To the extent Lilly personnel may have participated in this program, Lilly apologizes to those patients affected by it,” said spokeswoman Debbie Davis. “We are investigating this matter vigorously, and if company policies were violated, Lilly will take appropriate action.”

The FDA--which regulates prescription medicines, their makers and their marketing--is monitoring the case to see whether it needs to intervene.

“Although the acts of prescribing and providing the drug likely come under state jurisdiction, FDA intends to keep an eye on this case because of the promotion issues it may raise,” said spokesman Larry Bachorik.

The Broward County woman, identified in court documents only as S.K., this week sued her doctors, Walgreens and Lilly, charging invasion of privacy and improper medical practice.

“Dear Patient,” reads a letter accompanying the pills that was signed by her local doctors. “We are very excited to be able to offer you a more convenient way to take your antidepressant medication.

“For your convenience, enclosed you will find a free one-month trial of Prozac Weekly,” the letter continues. It tells patients to stop their regular antidepressant a day before starting the once-a-week version.

“It really upset me,” S.K. said in a telephone interview arranged by one of her attorneys, Stephen Sheller of Philadelphia.

She said her grandchildren might have opened and swallowed the mailed drug, and anyone seeing her mail would learn she suffers from depression, which she keeps private. “Then I started to think, ‘Wait a minute, how did they know to send them to me?’ ”

S.K. said her doctor maintains that the office physicians signed a blank form letter provided by a Lilly salesman. S.K.’s medical records show no Prozac prescription, said fellow attorney Gary Farmer Jr.

Representatives of the doctors’ office, Holy Cross Medical Group, did not return calls.

The lawsuit charges that Walgreens must have allowed access to patient prescription records.

Walgreens didn’t allow anyone access to patient records and properly filled prescriptions from doctors’ offices for all the Prozac it mailed, said Michael Polzin of the chain’s Deerfield, Ill., office.