Released by FDA: 5/13/02.  Posted by FDA:  5/21/02

Leslie Rogers, MD 
Director, Regulatory Affairs 
GlaxoSmithKline
P.O. Box 13398 
Five Moore Drive 
Research Triangle Park, NC 27709

RE:   NDA 20-132
        Imitrex (sumatriptan succinate) Tablets 
        MACMIS 1D#: 10795

Dear Dr. Rogers:

This letter notifies GlaxoSmithKline (GSK) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct-to-consumer television (TV) advertisement (ad) that is in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.  Specifically, the 60 second DTC TV ad "Hospital Nursery" (submitted on FDA Form 2253) makes an unsubstantiated and hence misleading comparative claim about Imitrex Tablets.

Misleading Comparative Claim

The TV ad is misleading because it suggests that Imitrex is more effective than has been demonstrated by "substantial evidence" (generally, two adequate and well-controlled head-to-head clinical trials).  The beginning of the ad portrays a nurse migraine sufferer looking at a stout amber prescription medicine bottle in conjunction with her voiceover "...a migraine my medicine just dulled the pain.  So I talked to my doctor.  He prescribed Imitrex.  Imitrex targets your total migraine."   The stout amber bottle is likely to be identified by consumers as containing a prescription medicine (i.e., her regular pain reliever).  As you know, there are several competing prescription pain relievers sold in this type of container.  This video portrayal referring to another prescription medicine, combined with the "medicine just dulled the pain" claim, implies that Imitrex is superior to another prescription pain reliever(s), in the absence of substantial evidence.  See 21 CFR § 202.1(e)(6)(ii).  FDA is not aware of any studies comparing Imitrex to other prescription pain relievers.  Therefore, this presentation is in violation of the Act because it makes an unsubstantiated and hence misleading comparative claim.

Requested Action

GSK should immediately discontinue this ad and all other promotional materials and activities for Imitrex that contain the same or similar violative presentations.  GSK should submit a written response to DDMAC on or before May 28, 2002, describing its intent and plans to comply with the above. I n its letter to DDMAC, GSK should include the date on which this and other similarly violative materials were discontinued.

GSK should direct its response to Lisa L. Stockbridge, Ph.D., by facsimile at (301) 594-6771, or by written communication at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42, Rm. 17-B-20, 5600 Fishers Lane, Rockville, Maryland 20857.

In all future correspondence on this matter, please refer to MACMYS ID# 10795 as well as the NDA number.  DDMAC reminds you that only written communications are considered official.

Sincerely,

 

Joan Hankin, JD
Consumer Promotion Analyst 
Division of Drug Marketing,
Advertising, and Communications