DTC Side Effects Include a Risk of State and Federal Crackdowns1 Jun, 2009 By: Response Contributor Response
For the first time in direct-to-consumer (DTC) pharmaceuticals marketing, the U.S. Food & Drug Administration (FDA) ordered a business to spend money on re-marketing a product to clarify misleading information in its ads.
Direct-to-consumer pharmaceutical marketers seek creative ways to cope with an epidemic of new restrictions.
In an unprecedented display of penalization, the FDA in February required Bayer HealthCare Pharmaceuticals, the manufacturer of Yaz — the "beyond birth control" pill — to spend $20 million in remedial marketing and submit all future DTC Yaz ads for approval. The lawsuit was initiated by 27 state attorneys general against one of the most popular and heavily marketed prescription drug brands in the U.S.
The Yaz television commercials and print ads were typified by stylish, independent women taking control of their lives by presumably overpowering the effects of PMDD (premenstrual dysphoric disorder) — which include moodiness, anxiety, headache, fatigue and irritability — by taking the product.
The FDA ordered Bayer to to re-market Yaz after original television advertisements made claims that the drug not only treated symptoms of PMDD, a rare and serious disorder, but also treated symptoms of the more common PMS.
The FDA found the ads problematic because Yaz was approved only to treat symptoms of PMDD, not PMS (premenstrual syndrome), whose symptoms also include headache, fatigue and irritability. PMS affects millions of women whereas PMDD is a rare, serious disorder.
The commercials stated that Yaz treated PMDD. However, they did not clearly explain that Yaz wasn't approved for PMS. During this time, direct response-driven sales of Yaz in the United States increased to about $616 million, compared to $262 million in 2007, according to health market researcher IMS Health.
In a warning letter issued in October 2008 to Bayer, the FDA said that the commercials failed to clearly make this distinction, and that they also did not explicitly state the risks and side effects associated with Yaz. The commercials were said to be in violation of a 2007 agreement between Bayer and the FDA — an agreement that was reached after an earlier run-in for alleged deceptive advertising for Baycol, a cholesterol-lowering drug, which failed to disclose risks and side effects.
The warning letter regarding Yaz stated: "The TV ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug. Thus, the TV ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act, and FDA's implementing regulations."
Bayer's first do-over spot begins: "You may have seen some Yaz commercials recently that were not clear," the actress says to the audience. "The FDA wants us to correct a few points in those ads."
GoInsulin.com is a place for consumers to share stories without the distraction of a hard sell or product promotion.