Selling drugs from your home – maybe not such a good idea, says FDA

Bringing it All Back Home

Here’s the scene: A dozen or so women are gathered in a living room. One stands, greets the others, then starts an easygoing sales pitch.

This isn’t a scene from 1965, it’s 2010. And the product isn’t Tupperware…

Here’s the pitch: “Thanks so much for joining us this evening. And, thank you (party host name) for opening your home. I’m (name) and (role) for Mom Central and I want to welcome everyone to this Simple Style Statements party.

“This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!”

No kidding. That’s part of a real script developed by Bayer and Mom Central, a social networking website. And this “Mirena Simple Style Statements Program” is a whole new way to sell drugs directly to consumers.

Thing is, Bayer and Mom Central didn’t exactly play by the rules. And that recently brought a stern letter from the FDA. Fortunately for us, that letter contains some unintentional hilarity that, of course, I’m going to share with you.

Thanks, FDA!

Get me rewrite

Mirena is a Bayer birth control delivery system for women who have had at least one child. Here’s how an article on the Mom Central site describes it: “A removable IUC (intrauterine contraceptive) that works for up to five years, it helps to simplify life and foster spontaneity in a wired world.”

See, in our wired world, it’s not enough for a birth control method to control birth. It’s got to multitask! It’s got to streamline life while also rekindling romance and passion.

So according to the party script, Mirena “allows for spontaneous intimacy,” and suggests that this one-of-a-kind birth control method will help women “reconnect” with partners.

And then along comes the FDA to spoil the party: “FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes…must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials.”

But here’s the real buzzkill: The FDA notes that according to Mirena’s product labeling, “…at least 5% of clinical trial patients reported DECREASED LIBIDO as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.”

This might be a first: the FDA discussing matters of romance.

Back to the script: “Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.”

That’s definitely a plus! It’s also false.

The FDA letter notes that Mirena product labeling calls for monthly examination of threads attached to the IUC. If the threads are displaced, pregnancy may occur. Also, patients have to be reexamined by their doctor within 12 weeks after the device is inserted, then at least once a year after that.

But here’s the real howler from the party speech: “What this party is really about is…figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding birth control that is compatible with your busy lifestyle.”

The agency is having none of it: “FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from ‘looking and feeling great.'”

Hard to argue with that.

Looks like Bayer is going to have to call Hollywood for a rewrite of their party script. In the meantime, you’ll know this revolution in drug marketing is taking off if you’re invited to a high cholesterol party and a friendly drug rep is handing out statin gift bags.

To Your Good Health,

Jenny Thompson

Source:
“Tupperware Parties And Prescription Drug Marketing: FDA Puts The Lid On A Drug Promotional Campaign” Daniel Kracov and Mahnu Davar, Consumer Advertising Law Blog, 1/19/10, consumeradvertisinglawblog.com