Released by FDA: 11/15/00.  Posted by FDA:  12/6/00

Ms. Roma Plakyda 
Regulatory Services Specialist 
Bristol-Myers Squibb Company
P.O. Box 4500
Princeton, NJ 08543-4500

Re:   NDA 21-145
        Vaniqa (eflornithine hydrochloride) Cream, 13.9%
        MACMIS ID#9515

Dear Ms. Plakyda:

As part of our routine monitoring program, the Division of Drug Marketing, Advertising,  and Communications (DDMAC) has reviewed a direct-to-consumer (DTC) broadcast television advertisement (A2K011) for Vaniqa (eflornithine hydrochloride cream, 13.9% disseminated by Bristol-Myers Squibb Company (BMS).  DDMAC has concluded that the broadcast advertisement is in violation of the Federal Food, Drug and Cosmetic Act and its implementing regulations for the following reasons:

Your broadcast advertisement is misleading because it minimizes important contextual information regarding Vaniqa through the use of small type size and ambiguous language.  The advertisement briefly displays a SUPER in small sized type that states, "Works with current hair removal methods."  This language inadequately communicates the concept discussed in the approved patient labeling about the necessity of continued use of the patient's current hair removal techniques while using Vaniqa.

Furthermore, your broadcast advertisement does not fulfill the requirements for adequate provision of the approved product labeling.   The presentation of the 1- 888  phone number and the website SUPER, combined with other text presented in the same frame, lacks sufficient prominence, spacing, and contrast to be legible and understandable by the viewer.  This issue was discussed with BMS in our September 27, 2000, comment letter. 

Action Requested

You should immediately cease the airing of’ this television broadcast advertisement and the use of all other promotional materials for Vaniqa that contain the same or similar presentations cited in this letter.  You should submit a written response, on or before November 30. 2000, describing your intent and plans to comply with the above.  Your letter should include a list of all promotional materials that were discontinued, and the discontinuation dates.

You should direct your response to me by facsimile at (301) 594-6771. or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42. Rm. 17 B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official.  In all correspondence regarding this particular submission, please refer to MACMIS ID# 9515 in addition to the NDA number.

Sincerely,

 

Cheryl Y. Roberts, MS, JD
Regulatory Review Officer
Division of  Drug Marketing,
   Advertising and Communications