Eli Lilly Receives FDA Warning Letter - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Eli Lilly Receives FDA Warning Letter


ePT--the Electronic Newsletter of Pharmaceutical Technology

Eli Lilly has received an FDA Warning Letter because of a “misleading” image of a multicolored brain scan that appeared on the company’s website for the diagnostic Positron Emission Tomography (PET) tracer, Amyvid. Amyvid is indicated for PET brain scans to review β-amyloid neuritic plaque density in patients who are being evaluated for Alzheimer’s Disease.

According to FDA, the use of the colored brain image classifies as misbranding because Amyvid’s product labeling states that Amyvid images must be displayed and reviewed in black and white. Black and white scale “with the maximum intensity of the scales set to the maximum intensity of all the brain pixels” is necessary for accurately reviewing the scans. Amyvid’s product information also includes several black and white example scans to illustrate interpretation. The use of a color image suggests that the scans can be displayed and interpreted in color.

“While many PET images are displayed and reviewed in color, Amyvid scans...must be displayed and reviewed using a black and white scale,” states FDA’s Warning Letter. “Additionally, the [product insert] does not provide instructions for estimating β-amyloid neuritic plaque density using a color scale with Amyvid. Therefore, use of color PET scan image of a brain in Amyvid promotional materials is misleading.”

The image has also been used in other marketing materials, including in the commercial exhibit hall of the American Academy of Neurology annual meeting, which was held in New Orleans, April 23–26, 2012.

Eli Lilly has not yet issued a press statement in response to the Warning Letter.

Amyvid was approved by FDA in April 2012, but received a complete response letter from FDA in March 2011 because of concerns about how to review and interpret Amyvid scans. In response, Eli Lilly created a specific training program.

Related Articles

PhRMA’s Research and Hope Awards Unveiled

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here