Released by FDA: 7/12/01.  Posted by FDA:  7/30/01

Rita A. Wittich
Vice President, Worldwide Regulatory Strategy 
Regulatory Affairs
Pfizer Inc
235 East 42nd Street 
New York, NY 10017

RE:    NDA #20-702
           Lipitor (atorvastatin calcium) Tablets 
           MACMIS ID# 9607

Dear Ms. Wittich:

This letter concerns a journal advertisement (BC121A00) for Lipitor (atorvastatin calcium) tablets disseminated by Pfizer Inc.  As part of its routine monitoring program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this journal advertisement and concluded it is false or misleading, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. Our specific objections follow:

Promotion of Unapproved Use

Lack of Fair Balance

The journal ad is misleading because it fails to present important information concerning the risks associated with Lipitor with a prominence and readability reasonably comparable to the presentation relating to the effectiveness of the drug.  For example, you present efficacy claims such as "Lipitor provides impressive LDL-C reductions," "72% of patients reached their NCEP LDL-C goal at 10 mg," and "Powerful effect on lipid parameters" as large headers that are bolded for further emphasis.  You also present specific reductions in LDL-C, TG, and HDL-C very prominently by the use of bolding and large type size.  In contrast, important risk information is presented in small type size on the bottom of page 6 and is further de-emphasized by its presentation in paragraph form without any header or signal to alert readers to its importance. Therefore, the journal ad lacks fair balance taking into account implementing factors such as layout, paragraphing, white space, and other techniques apt to achieve emphasis.

Broadening of Indication

The Indications and Usage section of the Pl states, "Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate."  Your advertisement contains prominent claims about Lipitor's usefulness, such as "Lipitor provides impressive LDL-C reduction."   However, you have minimized important information regarding the approved indication for Lipitor.  Specifically, the indication statement is presented at the bottom of page 6 in paragraph format and a 'small font size, making it difficult to read.  Moreover, the disclaimer "when diet and exercise fail" is also presented in a much smaller font size than the claims describing Lipitor's use.  As a result, the advertisement suggests that all patients, including those with high cholesterol who have not tried to lower cholesterol using diet and exercise, are candidates for Lipitor.  Therefore, the ad is misleading because it broadens the approved indication by minimizing information about the correct use of Lipitor.

In order to address these objections, you should immediately cease distribution of this journal ad immediately and all other promotional materials for Lipitor that contain the same or similar claims or. presentations.  You should respond in writing by July 26, 2001, with your intent and plans to comply with this request. Your response should include a list of materials discontinued, and the date on which these materials were discontinued.

If you have any further questions, please direct them 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 1713-20, 5600 Fishers Lane, Rockville, MD 20857.

We remind you that only written communications are considered official.  In all future correspondence regarding this particular matter please refer to MACMIS ID #9607 in addition to the NDA number.

Sincerely,

 

Andrew S.T. Haffer, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising, and Communications