Colored Brain Sparks FDA Warning Letter

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Warning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them.

Warning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them. Not only are warning letters issued by FDA for cGMP deficiencies, letters can also be initiated by marketing or advertising blunders, including the misuse of social media and product websites.

Last week, Eli Lilly received an


after the agency’s routine monitoring and surveillance program spotted an image of a colored brain on the website for Amyvid, a diagnostic PET tracer used by healthcare professionals when evaluating Alzheimer’s Disease and other causes of cognitive decline. According to FDA, the brain classifies as misbranding because Amyvid’s product labeling states that images must be displayed and reviewed in black and white.

It’s not just the website image either that Eli Lilly has been pulled up over; the image also appeared in the commercial exhibit hall of the American Academy of Neurology annual meeting, which was held in New Orleans in April earlier this year.

According to FDA, the coloured image “misleadingly” suggests that Amyvid PET images can be displayed and interpreted in colour. Many PET images are reviewed in colour, but Amyvid scans must be displayed and interpreted in black and white only. FDA also added that “the PI [product labeling] does not provide instructions for estimating b-amyloid neuritic plaque density using a color scale with Amyvid”.

Amyvid’s product labeling states that the scans should be displayed using a black and white scale, with the maximum intensity of the scale set to the maximum intensity of all the brain pixels. Image interpretation is based on comparing radioactivity in cortical gray matter with activity in the adjacent white matter. The labeling also provides several examples (in black and white) to aid proper image identification. Examples are shown on the Amyvid website.

When it comes to marketing and advertising, colour is important so perhaps it’s no surprise that Eli Lilly would choose a colour image over a black and white one for advertising purposes. The letter highlights the challenge for pharmaceutical companies to remain compliant, not only in cGMP, but also in marketing and advertising materials that may appear in print, online or on social media pages. Pharmaceutical companies are already keeping a wary eye on how they use social media and how they display information on their websites. It looks as if color and images will be further points that need to be carefully considered.