Released by FDA: 4/16/01.  Posted by FDA:  4/24/01

Kristina Spranger 
Manager, Worldwide Regulatory Strategy 
Pfizer Inc. 235 East 42nd Street 
New York, New York 10017

Re:  NDA # 20-130 
       Estrostep (norethindrone acetate and ethinyl estradiol) Tablets
       MACMIS # 9920

Dear Ms. Spranger:

Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a professional journal advertisement (ID EXO53A01) for Estrostep (norethindrone acetate and ethinyl estradiol) Tablets that is misleading and in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations.

Specifically, this journal advertisement claims that there are “new findings” that “show no significant weight gain associated with Estrostep.”   The claim is misleading because it is not supported by adequate and well-controlled clinical trials.   Furthermore, the histogram depicted in the journal advertisement implies that the two-pound difference between Estrostep and placebo is a benefit.   However, this difference is not clinically significant.

The journal advertisement cites data from two multi-center 6-month studies to support the claim that Estrostep showed no significant weight gain.  These studies are inadequate to support this claim because weight gain or loss was not a prospectively defined endpoint.  Instead, it was determined through a post-hoc analysis of the risk assessments from these studies.  Thus, DDMAC has concluded that claims that state or imply that weight gain is not a concern with Estrostep are not supported.

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

1. Immediately discontinue the use of this journal advertisement and any other promotional material and practices with the same or similar messages, including the tagline “weighs in right for OC users.”
   
   
2. Respond to this letter by April 30, 2001. 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 Dr. Lisa L. Stockbridge by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, FIFD-42, rm. 1 7B-20, 5600 Fishers Lane, Rockville, MD 20857.  DDMAC reminds you that only written communications are considered official.  

In all future correspondence regarding this particular matter, please refer to MACMIS ID# 9920 in addition to the NDA number.

Sincerely,

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