Released by FDA: 11/14/00. Posted by FDA: 12/6/00
Jerome M. Prahl
Associate Director
Regulatory Affairs
G.D. Searle & Co.
4901 Searle Parkway
Skokie, Illinois 60077
RE: NDA 20-998
Celebrex (celecoxib)
capsules
MACMIS ID #9514
Dear Mr. Prahl:
This letter refers to G.D. Searle & Co’s (Searle) submission of direct-to-consumer (DTC) promotional materials under cover of Form FDA 2253 for Celebrex (celecoxib) capsules. This submission included a 60-second “full product” broadcast television (TV) advertisement and a 15-second “reminder” TV advertisement, identified as CF20243T and CE20567T, respectively. The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed these broadcast advertisements and has concluded that they are in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Our specific objections follow:
Full Product Advertisement
 | The 60-second “full product” TV advertisement is misleading because the totality of the images, the music, and the audio statements that you present overstate the efficacy for Celebrex. For example, supers such as “Bill--arthritic knees,” various multiple physical activities portrayed by arthritis patients (such as rowing a boat and riding a scooter), the soundtrack “Celebrate, Celebrate. Do what you like to do.” and the audio statement. “Powerful 24-hour relief from osteoarthntis pain and stiffness.” collectively suggest that Celebrex is more effective than has been demonstrated by substantial evidence. |
Reminder Advertisement
| Reminder advertisements call attention to the name of the drug product, but may not contain written, printed, or graphic representations or suggestions relating to the drug product. Your advertisement is misleading because the audio statement, “Celebrate. Celebrate. Do what you like to do.” makes a representation or suggestion about the efficacy of Celebrex. |
Requested Actions
You should immediately cease distribution of these violative broadcast TV advertisements and other similar promotional materials for Celebrex that contain the same or similar claims or presentations. You should submit a written response, on or before, November 29, 2000, describing your intent and plans to comply with the above. Your letter should also include a list of materials discontinued and the date on which these materials were discontinued.
You should direct your response to me by facsimile at (301) 594-6771, or by writing at the Food and Drug Administration, Division of Drug Marketing. Advertising and Communications, HFD-40, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official.
In all future correspondence regarding this matter, please refer to the MACMIS # 9514 and the NDA number.
Sincerely,
Spencer Salis, Pharm.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising and Communications
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