Released by FDA: 6/29/01.  Posted by FDA:  7/31/01

Ms. Andrea Garrity 
Director, Regulatory Affairs 
Pfizer, Inc. 
235 East 42nd Street 
New York, New York 10017-5755

Re:   NDA #s 20-235, 20-882 
         Neurontin (gabapentin) 
         MACMIS # 10174

Dear Ms. Garrity:

Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a slim jim (ID #NSJ5O95A1) for Neurontin that is misleading and in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations.

Specifically, this slim jim misleadingly claims improvement in quality of life (QOL) parameters based on the Neurontin Evaluation of Outcomes in Neurological Practice (NEON) study.   Among other QOL parameters, the misleading presentation includes improvement in social limitations, memory difficulties, energy level, and work limitations. The NEON study is not considered to be substantial evidence for claims of QOL improvements because it is not a controlled study.

To address these objections, DDMAC recommends that Pfizer do the following:

1.  Immediately discontinue the use of this slim jim and any other promotional material and practices with the same or similar messages.

2.  Respond to this letter within ten days.   Your response should include a statement of your intent to comply with the above, a list of all promotional materials with the same or similar issues, and your methods for discontinuing these promotional materials.

If you have any questions or comments, please contact Ms. Laurie Burke by facsimile at (301) 594- 6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, Rm 17B-20, 5600 Fishers Lane, Rockville, MD 20S57.   DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS II) # 10174 in addition to the NDA number.

Sincerely,

 

Lisa L. Stockbridge, Ph.D. 
Regulatory Reviewer 
Division of Drug Marketing, 
   Advertising and Communications