The US Food and Drug Administration (FDA) has sent a warning letter to pharmaceutical manufacturer Eli Lilly over alleged deficiencies present in marketing materials distributed by the company through its website, FDA announced on 10 September.
The letter, posted on FDA's website by the Office of Prescription Drug Promotion (OPDP), references marketing materials published for Amyvid (Florbetapir F 18 Injection), a positron emission tomography (PET) drug used to help evaluate patients who may have Alzheimer's disease.
Amyvid was approved in April 2012 by FDA, at which time regulators said it represented a jump forward in being able to detect the presence of β-amyloid neuritic plaque, a protein buildup understood to be associated with Alzheimer's disease and other cognitive impairments. Previously, the presence of plaque was only determinable using post-mortem tissue collection, FDA said.
After the drug's approval, Eli Lilly launched a website for the product, in which it used a multi-colored photo of a brain to supplement the website's aesthetics. Eli Lilly would also go on to use the same image in an exhibition it sponsored at the American Academy of Neurology's annual meeting.
In its warning letter to Eli Lilly, FDA said the image misbrands the drug because it, "Suggests that Amyvid PET images can be displayed, and therefore interpreted, in color."
"This is not the case," FDA remarked.
Scans generated with the use of Amyvid should be displayed and reviewed in black and white, as color PET scan images run the risk of being misinterpreted and causing errors, FDA explained.
It is unclear whether such errors may have occurred, as FDA recommended at the time of the drug's approval that the images only be interpreted by healthcare professionals who have undergone a, "Special training program developed by the manufacturer."
The Amyvid label also includes information on how to interpret the Amyvid PET images. "In reviewing the images, include all transaxial slices of the brain using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all the brain pixels," says the label.
Eli Lilly Responds
The Amyvid website has since been updated by Eli Lilly, with an out-of-focus photo of a black-and-white brain scan replacing the colorful version censured by FDA.
"Eli Lilly takes these matters very
seriously," said Lilly spokeswoman Keri McGrath in a statement to Regulatory Focus. "Lilly took immediate steps to discontinue use of multi-colored brain
images in promotional materials and has addressed the agency's concerns."
McGrath explained that the use of color in its advertising and promotional materials was a, "Creative design element," and the image itself was only intended as a," Stylistic background."
All other promotional content for Amyvid has since been redesigned to conform with FDA's warning letter, said McGrath.