FDA Slams Lilly, Says It Misbranded Alzheimer's Imaging Test

Earlier this year, the FDA approved an imaging agent from Eli Lilly (LLY) for detecting beta-amyloid plaques in patients with cognitive impairment and who are being evaluated for Alzheimer’s disease. Known as Amyvid, this is the first diagnostic agent approved for people who undergo a positron emission tomography, or PET, scan. But the approval was not a slam dunk – the agency initially declined to approve Amyvid over concerns that scans can be accurately read.

Now, the FDA has tagged Lilly for offering physicians what the agency calls a misleading way to interpret scan results on the Amyvid web site and in recent displays at a medical conference. To wit, Lilly offered a multi-colored image of the brain, when the Amyvid labeling information says PET scans should be displayed and reviewed using a black-and-white scale “with the maximum intensity of the scale set to the maximum intensity of all the brain pixels.”

Why does this matter? In August 10 untitled letter, the FDA writes this “presentation misleadingly suggests that Amyvid PET images can be displayed, and therefore interpreted, in color in patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline, when this is not the case… While many PET images are displayed and reviewed in color, Amyvid scans must be displayed and reviewed using a black and white scale.”

And so, the FDA has accused Lilly of misbranding its product. The offending image, by the way, no longer appears on the Amyvid web site (look here), but the FDA says its Office of Prescription Drug Promotion was also made aware that the colorful scans appeared in the commercial exhibit hall of the American Academy of Neurology annual meeting held in New Orleans last April.

To read the remainder of this article, go to Pharmalot.

Ed Silverman is the editor of Pharmalot and a contributor toYCharts Pro Investor Service which includes professional stock charts, stock ratings and portfolio strategies.

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