As part of its routine monitoring and surveillance program, the FDA’s Office of Prescription Drug Promotion (OPDP), division of professional drug promotion has reviewed a website for Florbetapir F-18 Injection (Amyvid), and found it includes “a misleading multi-colored image of the brain,” according to the agency.
Additionally, OPDP said it has been made aware that “these misleading images” appeared in the commercial exhibit hall of the American Academy of Neurology annual meeting held in New Orleans, April 23-26. OPDP has determined that the materials “misbrand” Amyvid in violation of the Federal Food, Drug and Cosmetic Act.
The letter, written by James S. Dvorsky, PharmD, a regulatory review officer at OPDP, was addressed to Josephine Secnik, MS, MBA, director, U.S. global regulatory affairs at Lilly.
This presentation “misleadingly suggests that the 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,” stated the FDA.
According to the Dosage and Administration section of the prescribing information (PI), Amyvid PET scans should be displayed and reviewed “using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all the brain pixels.” The agency said the PI further includes several examples of black and white scans to illustrate proper image interpretation.
Although many PET images are displayed and reviewed in color, Amyvid scans must be displayed and reviewed using a black and white scale, the FDA warning letter stated. Additionally, the PI does not provide instructions for estimating beta-amyloid neuritic plaque density using a color scale with Amyvid.
“Therefore, use of the color PET scan image of a brain in Amyvid promotional materials is misleading, particularly considering the warning regarding the risk for image misinterpretation and other errors,” the FDA wrote.
Thus, the OPDP declared Lilly in violation of the Federal Food, Drug and Cosmetic Act for misbranding Amyvid.