Released by FDA: 6/22/00.  Posted by FDA:  7/17/00

Mark Moyer 
Director Regulatory Affairs 
Sanofi-Synthelabo, Inc. 
9 Great Valley Parkway 
Malvern PA 19355

RE:    NDA
         Eloxatin (oxaliplatin) 
         MACMIS ID # 9076

Dear Mr. Moyer:

The Division of Drug Marketing, Advertising, and Communications (DDMAC), as part of its routine surveillance program, has received information that pre-approval promotional activities for Eloxatin (oxaliplatin) have been conducted by Sanofi-Synthelabo, Inc. (Sanofi) in violation of the Federal Food, Drug, and Cosmetic Act (the Act), and regulations promulgated thereunder.  Specifically, Sanofi disseminated promotional materials about Eloxatin, an investigational drug, that suggest that it is effective for treating different types of cancer.  Section 312.7 of title 21 of the Code of Federal Regulations (C.F.R.) specifically states that a “sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational drug is safe or effective for the purposes for which it is under investigation.”

At the May 1 9-23, 2000, meeting of the American Society of Clinical Oncology (“ASCO”) in New Orleans, LA, Sanofi had a booth in the commercial area where Sanofi representatives distributed material that promoted Eloxatin for use in the treatment of solid tumors.  For example, the slide kit entitled, “Oxaliplatin -- A Novel Compound Under Investigation for the Treatment of Solid Tumors” included conclusory statements such as:

“... oxaliplatin is active against several cisplatin-resistant cell lines, colon carcinoma, and other solid tumors that are not responsive to cisplatin.”

“[results from colon cell line studies] support the clinical indication of 5-FU plus oxaliplatin in the treatment of colon carcinoma.” 

“In vivo antitumor studies were conducted with oxaliplatin in combination with CPT-11, cyclophosphamide [], mitomycin-C, carboplatin and cisplatin [], and 5-EU.  All combinations had additive or better than additive activity when compared to each agent alone.”

Your presentation clearly suggests that Eloxatin is effective for the treatment of colon cancer and other solid tumors.

DDMAC requests that Sanofi immediately suspend all promotional activities and the dissemination of all promotional material for Eloxatin.  Please address your response to the undersigned at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, Rm 17-B-20, 5600 Fishers Lane, Rockville, Maryland 20857.  Within ten business days of receiving this correspondence, please provide written notice of your intention to comply with this request.  Your response should include a list of all materials that you have discontinued and the date of discontinuation.  DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID # 9076.

Sincerely,

Jean-Ah Choi, Pharm.D.
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising and Communications