The Food & Drug Administration has recently notified Eli Lilly & Co. and Bayer Healthcare that it has objections to ads used for some of their drugs.
For Eli Lilly, it was print advertisements for its depression drug, Cymbalta. Print ads used on WebMD Little Blue Book; a publication to assist patients in locating physicians and other medical services. The FDA set forth that “…the main body of the print ad entirely omits risk information, including the contraindications, warnings and precautions, and the most frequently reported adverse reactions from the [product labeling]” This required information was set forth in a box on an adjacent page, but the FDA felt that it was not “sufficient to provide appropriate qualification or pertinent information for the claims made in the body of the ad or to mitigate the overall misleading presentation,”. An Eli Lilly spokesman responded:
“Lilly remains confident in Cymbalta’s efficacy and safety in its approved indications…”
I am not sure that Eli Lilly really gets the point the FDA is trying to make and one might argue their TV ads are less about the drug and more about “spin”:
For Bayer Healthcare it is their advertising for the drug, Mirena. The FDA’s concerns expressed are very familiar and similar to those already expressed to Bayer and involving its birth control products, Yaz and Yasmin. In the case of Mirena, the FDA set forth that:
“These claims misleadingly overstate the proven efficacy of Mirena,” the letter said. “Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, 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.”
It would seem that Bayer cannot seem to grasp that marketing prescription drugs to the consumer is about providing complete and adequate information so consumers can make informed decisions and ask their physicians relevant questions about drugs. What marketing prescription drugs directly to consumers is NOT about is “Broadway show” types of productions or the sort of misdirection one can expect from a “three card Monte” carnival huckster.
Drug manufacturers, such as Bayer and Eli Lilly, have been selling over the counter, prescription drugs for a long time. They certainly should fully understand the regulations governing advertising and they certainly appreciate the FDA’s need for good information to unsophisticated consumers. It is one thing to use “sleight of hand” advertising with a sophisticated audience such as physicians, but to be more interested in dramatic, glitzy, productions as opposed to accurate, solid information in the case of direct to consumer advertising, is simply wrong.
Do the manufacturers have trouble understanding the FDA regulations?
Of course not. They pay good money to people who are particularly skilled at understanding the advertising regulations. Perhaps the manufacturers are simply testing the extent to which they can push the limits of regulations in order to ramp up sales? Perhaps drug manufacturers have come to believe that regulations are made to be broken; at least long enough to give a product a solid and quick boost in public recognition before they are caught breaking the rules?