Ever since the Tupperware Company revolutionized direct-to-consumer (“DTC”) marketing through its famous “Tupperware™ parties” of the 1950s, manufacturers have been trying mimic its success. Pharmaceutical manufacturers are among the latest to revive this “old school” technique, and FDA has taken notice.
On January 12, 2010, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) posted a December 30, 2009 letter to Bayer HealthCare Pharmaceuticals Inc. (“Bayer”) on its website objecting to a script for a live consumer-directed program for the drug Mirena® entitled “Mirena Simple Style Statements Program” (“Program”). Mirena (levonorgestrel-releasing intrauterine system) is a drug delivery system indicated for intrauterine contraception for up to five years. The drug carries various contraindications and warnings and the FDA-approved label (“PI”) requires that patients be “reexamined and evaluated 4 to 12 weeks after insertion, and once a year thereafter, or more frequently if clinically indicated”.
The Program was developed as a partnership between Bayer and Mom Central, a commercial social networking site “dedicated to providing busy moms with smart household and parenting solutions”. According to FDA’s letter and the allegedly violative Program script, the Bayer-sponsored Program is presented in a consumer’s home or another private setting (such as a private restaurant party). A Mom Central representative starts the presentation with a scripted introduction and then hands the presentation off to a nurse practitioner who follows a scripted Mirena product presentation. After a question and answer session, the nurse practitioner (who Bayer says is trained to keep her messaging consistent with the Mirena PI) hands off the presentation to a stylist who offers fashion tips. The overall effect is to present Mirena as an attractive option to busy moms who are looking for a “lifestyle solution”.
The Mirena FDA letter underscores the need for the pharmaceutical industry to balance clever “lifestyle marketing” with FDA’s standards for substantiation for quality of life claims and risk/benefit balancing. In particular, FDA takes objection to statements in the Program script which suggest that Mirena increases levels of intimacy, romance, and emotional satisfaction. In FDA’s view, these statements overstate Mirena’s efficacy because they have not been proven to be quality of life outcomes supported by substantial clinical experience, noting that 5% of clinical trial patients actually reported decreased libido as a side effect. Further, the nurse practitioner was scripted to state that busy moms who use Mirena, “look and feel great”. FDA points out that this statement, among others, minimizes the risks associated with use of Mirena, which include, irregular bleeding, ovarian cysts, back pain, weight increase, acne and other risks which are not only inconsistent with “feeling great” but are also important risks that need to be communicated to consumers. Finally FDA notes that the script states that Mirena has “no daily, weekly, or monthly routines to comply with” as part of its overall message that Mirena fits into a convenient lifestyle. In fact, FDA notes that the Mirena PI requires both patient and physician follow up.
While presenting a prescription pharmaceutical product as an attractive lifestyle option may be a clever way to advertise directly to consumers, FDA’s response to this consumer program script has made clear that drugs are not Tupperware.
- Daniel Kracov and Mahnu Davar
