Released by FDA: 11/16/00.  Posted by FDA:  12/6/00

Gregory T. Brophy, Ph.D. 
Director, U.S. Regulatory Affairs 
Eli Lilly and Company 
Lilly Corporate Center 
Indianapolis, Indiana 46285

RE:   NDA#18-936 
        Sarafem (fluoxetine HCI) Tablets 
        MACMIS # 9523

Dear Dr. Brophy:

This letter concerns a 60-second Direct-to-Consumer (DTC) television broadcast advertisement (“Shopping Cart” ID# SA 18116) that Eli Lilly and Company (Lilly) has disseminated for Sarafem (fluoxetine HCI) Tablets.  As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this advertisement and concluded that it is misleading, lacking in fair balance, and therefore in violation of the Federal Food, Drug, and Cosmetic Act and its applicable regulations.

Specifically, DDMAC objects to the following issues in the DTC broadcast advertisement:

Inadequate Presentation of Indication

The graphics of the advertisement show a frustrated woman trying to pull her shopping cart out of its interlocked lineup in front of a store.  The concurrent audio states “Think it’s PMS? It could be PMDD.”  The imagery and audio presentation of the advertisement never completely define or accurately illustrate premenstrual dysphoric disorder (PMDD) and there is no clear distinction between premenstrual syndrome (PMS) and PMDD communicated.  Consequently, the overall message broadens the indication and trivializes the seriousness of PMDD, a disorder whose hallmarks include a markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability.  For a diagnosis of PMDD, these and other symptoms must markedly interfere with work, school, usual social activities, and relationships.

Fair Balance

The advertisement is lacking fair balance because the graphics accompanying the audio presentation of the risk information are very distracting and minimize the important risk information.  The distractions include competition from the imagery, scene changes, camera shots, and concurrent supers.

Adequate Provision

The elements of adequate provision in the advertisement appear as supers that lack prominence and readability.  Specifically, the font size is too small and the color lends insufficient contrast to the graphics in each scene.  Therefore, the advertisement does not fulfill the requirements for adequate provision of the approved product labeling.

Requested Action

DDMAC requests that Lilly immediately cease using this broadcast advertisement and all other promotional materials for Sarafem that contain the same or similar issues.  Lilly should submit a written response to DDMAC on or before November 30, 2000, describing its intent and plans to comply with the above.  In its letter to DDMAC, Lilly should include a list of all promotional materials that were discontinued and the date(s) of discontinuation.

If you have any further questions or comments, write to me at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, 5600 Fishers Lane, HFD-042, rm. 17B-17, Rockville, MD 20857.

DDMAC reminds you that only written communications are considered official. In all future correspondence regarding this matter, please refer to MACMIS #9523 in addition to the NDA number.

Sincerely,

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