On Sept. 6, 2012, the FDA issued a letter sent to Eli Lilly and Company regarding a web page for PET imaging compound Amyvid. The letter reads:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration Silver Spring, MD 20993
Josephine Secnik, MS, MBA Director, Global Regulatory Affairs– U.S. Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285
RE: NDA #202008
Amyvid™ (Florbetapir F 18 Injection) for intravenous use
MA #9
Dear Ms. Secnik:
As part of its routine monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP), Division of Professional Drug Promotion (DPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a webpage (AM77988) for Amyvid™ (Florbetapir F 18 Injection) (Amyvid), submitted by Eli Lilly and Company’s (Eli Lilly) under cover of Form FDA-2253. This webpage includes a misleading multi-colored image of the brain. Additionally, OPDP 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, Louisiana on April 23-26, 2012. OPDP has determined that the materials misbrand Amyvid in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
Background
Below are the indication and summary of the most serious and common risks associated with the use of Amyvid.1 According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI):
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scanresult reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.
1 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional piece cited in this letter.
Limitations of Use:
• A positive Amyvid scan does not establish a diagnosis of AD or other cognitive
disorder.
• Safety and effectiveness of Amyvid have not been established for:
o Predicting development of dementia or other neurologiccondition;
o Monitoring responses to therapies.
The PI for Amyvid contains Warnings and Precautions regarding the risk of image
misinterpretation and other errors as well as the risk of radiation exposure. In addition,
according to the ADVERSE REACTIONS section of the PI, the most commonly reported
adverse reactions include headache, musculoskeletal pain, fatigue, and nausea.
Misleading Presentation
The Amyvid webpage features a multi-colored brain image. 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. According to the DOSAGE AND
ADMINISTRATION section of the 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 PI further includes several examples of black and white
scans to illustrate proper image interpretation.
While many PET images are displayed and reviewed in color, Amyvid scans, as described
above, must be displayed and reviewed using a black and white scale. Additionally, the PI
does not provide instructions for estimating β-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.
Conclusion and Requested Action
For the reasons discussed above, this webpage misbrands Amyvid in violation of the FD&C
Act, 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
(b) (4)
Please direct your response to the undersigned at the Food and Drug Administration,
Center for Drug Evaluation and Research, Office of Prescription Drug Promotion,
Division of Professional Drug Promotion, 5901-B Ammendale Road, Beltsville,
Reference ID: 3173022
Josephine Secnik Page 3 Eli Lilly and Company NDA 202008/MA #9
Maryland 20705-1266 or by facsimile at (301) 847-8444. Please note that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has been reorganized and elevated to the Office of Prescription Drug Promotion (OPDP). OPDP consists of the Immediate Office, the Division of Professional Drug Promotion (DPDP) and the Division of Consumer Drug Promotion (DCDP). To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. In addition, OPDP recently migrated to a different tracking system. Therefore, OPDP letters will now refer to MA numbers instead of MACMIS numbers. Please refer to MA # 9 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Amyvid comply with each applicable requirement of the FD&C Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
James S. Dvorsky, PharmD Regulatory Review Officer Division of Professional Drug Promotion Office of Prescription Drug Promotion
{See appended electronic signature page}
Andrew S.T. Haffer, PharmD Acting Director Division of Professional Drug Promotion Office of Prescription Drug Promotion
Reference ID: 3173022
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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
JAMES S DVORSKY 08/10/2012
ANDREW S HAFFER 08/10/2012
Reference ID: 3173022
Promotional Material
Posted: September 2012
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