Released by FDA: 6/8/01.  Posted by FDA:  7/26/01

Kenneth Palmer, M.S , Associate Director
Drug Regulatory Affairs 
Sanofi-Synthelabo Inc. 
90 Park Avenue
New York, New York 10016

RE:    NDA 20-839 
          Plavix (clopidogrel bisulfate) 75 mg Tablets 
          MACMIS ID#: 10107

Dear Mr. Palmer:

This letter concerns Sanof-Synthelabo Inc ‘s (Sanofi) dissemination of a direct-to-consumer (DTC) television broadcast advertisement (ad) for Plavix Tablets (i.e.,  60 second direct espouse DRTV "Grandpa”/69202885).  The Division of Marketing, Advertising,  and Communications (DDMAC) reviewed this ad as part of its monitoring and surveillance program and concludes that it is misleading and fails to comply with regulatory requirements.   Therefore,  this ad violates the Federal Food, Drug, and Cosmetic Act and applicable regulations.   Our specific objections follow.

Misleading Minimization of the Role of the Physician in the Prescribing  Process

The broadcast ad is misleading because it minimizes the role of the doctor in determining whether Plavix is the appropriate medication to prescribe for the patients condition.  The narrative spoken by the “patient” (an actor portraying a grandfather)  lacks any clear and prominent mention of his need to talk to a doctor in deciding if Plavix is right for him (e.g., “I talked to my doctor about Plavix” or “Ask your doctor if  Plavix is right for you”).   The lack of this disclosure, in combination with the overall tone of the ad, undermines the prescription-only status of Plavix by implying that the patient alone, rather than in consultation with a health care professional, weights the product’s benefits and risks in deciding if Plavix is appropriate.   The overall presentation suggests that the patient merely needs to call a toll-free phone number to receive product information and make arrangements for getting the drug.   Furthermore. this misleading impression is not sufficiently remedied by the one-time reference to Plavix as a "prescription pill,” or to the SUPER  ‘‘Talk to your doctor” displayed later in the ad while risk information is being discussed.

Failure to Fulfill "Adequate Provision" Through Insufficient Presentation

The broadcast ad does not fulfill the regulatory requirement for ensuring “adequatc’ provision” for disseminating the approved product labeling.  One component of “adequate provision"  is the inclusion of’ a disclosure that healthcare providers, such as doctors, are an additional source of drug product information.   The SUPER “Talk to your doctor" appears during the description of product risk information but lacks the needed context to communicate that the physician is a source of product in formation.

Sanofi should immediately cease running this broadcast ad for Plavix and cease using any other promotional materials that contain the same or similar presentations.   We should receive your written response no later than June 22, 2001, and it should list any similarly violative materials, with a description of your method of discontinuation and the discontinuation date.

Your response should be directed to Andrew S.T. Haffer, Pharm.D., by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm l7-B-20, 5600 Fishers Lane, Rockville, Maryland 20857.   We remind Sanofi that only written communications are official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID# 10107 in addition to the NDA number

Sincerely,

 

Joan Hankin, J.D. 
Consumer Promotion Analyst 
Division of Drug Marketing, 
Advertising, and Communications