Released by FDA: 5/26/00.  Posted by FDA:  7/18/00

Ms. Christine (Duffy) Smith 
Leader, Promotional Regulatory Affairs 
AstraZeneca L.P. 
690 Lee Road (Building C) 
Chesterbrook, PA 19087-5627

RE:   NDA# 20-547 
        Accolate (zafirkulast) Tablets 
        MACMIS ID#: 9019

Dear Ms. Smith:

This letter concerns a piece of professional promotional labeling (i.e., visual aid AC1184) for Accolate (zafirkulast) Tablets disseminated by AstraZeneca Pharmaceuticals’ (AstraZeneca).  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this item and concluded that AstraZeneca is disseminating promotional labeling that lacks fair balance and is misleading.  This promotional labeling violates the Federal Food, Drug, and Cosmetic Act and implementing regulations and should be discontinued immediately.

This 16-page visual aid promotes Accolate for children ages 7 to 11 years and to older children and adults.  The piece includes several whole-page presentations promoting the safety of Accolate in adults (e.g., page 12 “The safety of Accolate in clinical studies”, page 13 “The real-world safety of Accolate”).  In each of these promotional safety discussions and in other presentations promoting the efficacy of Accolate, none of the accompanying fair balance disclosures includes PRECAUTION/ADVERSE EVENT information from the approved product labeling about Eosinophilic Conditions reported post-marketing.  For such extended safety-related claims or other risk discussions, the systemic eosinophilia disclosure is important information to provide health professionals for a complete presentation of potential risks associated with use of this drug. Therefore, this visual aid is misleading because it lacks fair balance disclosure about systemic eosinophilia.

AstraZeneca should immediately cease its dissemination and use of all professional promotional materials containing such presentations for Accolate that lack the systemic eosinophilia risk disclosure.  We should receive your written response no later than June 12, 2000, and it should list all similarly violative materials, with a description of your method of discontinuation. 

Your response should be directed to the undersigned at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, Rm 17-B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind AstraZeneca that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID# 9019 in addition to the NDA number.

Sincerely,

Joan Hankin, JD 
Regulatory Review Officer 
Division of Drug Marketing, 
  Advertising, and Communications