Released by FDA: 8/12/02.  Posted by FDA:  9/4/02

Christopher A. Graham
Director, Worldwide Regulatory Strategy
Pfizer Inc.
235 Fast 42^ndd Street
New York, NY 10017

RE:     NDA 20-702
          Lipitor (atorvastatin calcium) Tablets
          MACMIS ID#: 10939

Dear Mr. Graham:

This letter notifies Pfizer Inc. (Pfizer) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct-to-consumer (DTC) print advertisement (#LP 106204-B) for Lipitor (atorvastatin calcium) Tablets that is in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable regulations. The ad misleadingly suggests that Lipitor is safer than other statins.  The Lipitor DTC print ad has appeared in magazines with national distribution such as, Time, Reader's Digest, Good Housekeeping, Woman's Day, Cooking Light, and Health. The Lipitor "Brief Summary" part of the DTC print ad is misleading because it indicates that Lipitor may lack the side effects of other members of the statin class of lipid-lowering medications.

Specifically, DDMAC has the following objection to the DTC print ad "Brief Summary."

The Act and regulations require that prescription drug advertisements include a true statement of information relating to side effects, contraindications (including warnings, precautions, etc.), and effectiveness (21 U.S.C. 352(n) and 21 CFR 202.1(e)(1)), commonly referred to as the "Brief Summary."  By indicating in the "Brief Summary" that Lipitor has less serious risks associated with its use than other lipid-lowering statin medications, this ad is misleading, and therefore does not present a true statement of information in brief summary relating to side effects and contraindications.

Lipitor approved Product labeling

The Lipitor approved product labeling contains, among other risk information, the following warnings and precautions:

WARNINGS bolded /Skeletal Muscle section:

WARNINGS/Skeletal Muscle section:

PRECAUTION S/Dru Interactions section:

Lipitor "Brief Summary"

In contrast, the Lipitor "Brief Summary" as it appears in the full product DTC print ad contains, among other risk information, these statements:

WARNINGS bolded /Skeletal Muscle section:

WARNINGS/Skeletal Muscle section:

PRECAUTIONS/Drug Interactions section:

These statements in the Lipitor "Brief Summary" fail to disclose (indeed, they suggest to the contrary) that atorvastatin (Lipitor) has the same potential for risk of rhabdomyolysis (i.e., muscle deterioration exhibited by muscle pain, tenderness, or weakness) and myopathy as other lipid-lowering statin drugs.  Overall, this presentation suggests that Lipitor is safer than has been demonstrated.  The minimization of such serious risks associated with Lipitor therapy renders each Lipitor DTC print ad containing this "Brief Summary" misleading.

Pfizer should immediately discontinue this ad and all other promotional materials and activities for Lipitor that contain the same or similar violative presentations.  Pfizer should submit a written response to DDMAC on or before August 26, 2002, describing your intent and plans to comply with the above, and include the date on which this and other similarly violative materials were discontinued.

Pfizer should respond to the undersigned, by facsimile at (301) 594-6771, or in writing at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857.

In all fixture correspondence on this matter, please refer to MACMIS ID# 10939 as well as the NDA number. DDMAC reminds you that only written communications are considered official.

Sincerely,


Joan Hankin, JD
Consumer Promotion Analyst
Division of Drug Marketing,
   Advertising, and Communications