One of the FDA-approved graphic warning labels
Full disclosure: I have worked on Tobacco Prevention and Control social marketing campaigns for more than 10 years. As you may have heard, beginning September 2012 the FDA will require cigarette companies to place very large and graphic warning labels on the packaging of their cigarette products. The nine labels can be viewed here: http://www.fda.gov/TobaccoProducts/Labeling/CigaretteWarningLabels/default.htm.
These labels will have to cover the top half of the cigarette box and 20% of any tobacco advertisement. Read the rest of this entry »
The dangers of marketing genetic tests.
Some months ago, scientists sent samples of the same DNA to several direct-to- consumer (DTC) genetic testing services. When the reports came back the interpretations of the findings were wildly different. This has just been confirmed by the General Accounting Office and was reported on this week in Washington. So if you want to know if you’re predisposed to some ailment, don’t bother spending the $300 to $1,000 that these tests cost.
Even worse than the rotten results were the horrific marketing practices that the GAO uncovered: One firm claimed that the product they sold could “repair DNA.” Others claimed they could tell parents which sports their children would do well in. One woman was told she would definitely develop breast cancer, while another was assured that the company would test her fiancé’s DNA secretly. Read the rest of this entry »
The danger of marketing without FDA approval
The strange story of drug store–based genetic tests.
It was a quick trip on and off the shelves at several thousand Walgreens drug stores for Pathway Genomics direct-to-consumer genetic testing kit. Less than 48 hours after announcing the availability of the test kits, Walgreens pulled back due to an intervention by the Food and Drug Administration saying that the test was without regulatory approval, telling Genetic Pathways that it would be an “illegally marketed device.” In Act II of this genetic drama, CVS also pulled out of marketing the same product a few days ago.
For my money, I can’t believe they went to market without considering the FDA’s reaction. Naivety? Cockiness? When you work in a regulated environment, particularly one in which the regulations are under development and fluid, assume nothing. I have clients that have worked with the FDA, not around them, even thought their product did not require FDA approval. They obtained the guidance they needed to move forward and both parties were better off for the interaction.
Imagine all that must have been involved in doing two deals of this magnitude. But, according to the FDA, “if a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”
Duh!
Read another blog entry about this issue.
