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FDA INSIGHTS NEWSLETTER
A newsletter of priceless wisdom from former FDA officials
Truth in Advertising
By Carmen Medina, MPH, Ph.D.
Former FDA Investigator
As a former FDA investigator, I can tell you that the intentional omission or minimization of risk information is the most common FD-483 cited in the List of Observations and in Warming Letters. So it is not surprising that FDA just issued a new, proposed advertising guideline for drug and device manufacturers. The goal is to ensure that all product risk information is adequately presented to the public, consumers and health-care professionals.
The guidelines propose more concise language related to mitigating risks associated with certain products. It is no longer sufficient to note that a drug or device needs monitoring by a physician—the specifics must be listed. The agency is also evaluating consumer advertisements and physician detailing materials with an eye on whether or not they convey accurate and complete product information. Misleading ads such as having a pregnant woman in the foreground of a smoking cessation commercial, when the product has not actually been clinically tested on pregnant women would be considered false and misleading. Additionally, playing upbeat music, like “Let the Sun Shine” while displaying a product’s side effects would also be considered misleading.
The 24-page proposed guideline even gets into copy layout, font size, and the use of white space in printed materials as they best relate to presenting risk information.
See next FDA newsletter article:
FDA Fights Battle on Two Critical Fronts
Carmen Medina, MPH, Ph.D. (c) |
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FDA INSIGHTS |
