Yaz - Bad Ads
A lot of talk following Yaz and Yasmin has revolved around the contraceptive Yaz, produced by drug company Bayer. The FDA cited Bayer two years ago for the twin offenses of promoting the drug for uses it was not yet tested or approved for, and for downplaying the potential risks of the medicine. Since that time, a number of cases have been filed alleging links between Yaz and rising blood potassium levels that have lead to heart attacks and strokes in women on the medicine.
The offense in question is covered by the FDA's Truthful Prescription Drug Advertising and Promotion program, also called the Bad Ad program. Bad Ads is an organized set of guidelines intended to hold pharma companies such as Bayer accountable in television and online advertisement.
Guidelines from the Bad Ad program cover a lot of ground, and should give consumers more ammunition when they see an advertisement they suspect breaches the guidelines.
For example, advertisements for prescription drugs are required to be accurate about the details, both positive and negative, for each medication. The commercials also can't go against the prescription guidelines set out by the FDA. Furthermore, only evidence supported by clinical trials should be used in the commercials. Thus the Yaz “Balloons” commercial fails on all three counts — it downplayed the potential risks that were coming to light (point one) and promoted Yaz for uses the FDA had not put its approval to (points two and three).
The FDA assures consumers that if they wish, they can report a violation anonymously. In the case of a commercial on television, this is often a good course of action because just alerting the FDA will prompt it to see the commercial and begin asking questions. On the other hand, should the suspected breach be discovered during a private presentation at a convention or meeting, then the FDA does encourage whistleblowers to provide contact information so the case can be followed up more effectively.
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