Released by FDA: 2/2/01.  Posted by FDA:  2/5/01

Mr. Robert Miranda 
Associate Director 
Drug Regulatory Affairs 
Novartis Pharmaceuticals Corporation 
59 Route 10 
East Hanover, NJ 07936

RE:    NDA: 20-726 
         Femara (letrozole) Tablets 
         MACMIS ID # 9583

Dear Mr. Miranda:

Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of a Press Release (January 10, 2001) and an advertisement in the journal Oncology (2000;14(11):1522) for Femara (letrozole) Tablets.  DDMAC finds this promotional material to be false, misleading, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated there under.  Specifically, the Novartis Pharmaceuticals Corporation (Novartis) promotional material broadens the drug’s approved indication, lacks fair balance, inadequately communicates the approved indication, and fails to provide information in brief summary as required for prescription drug advertisements.

Press Release (January 10, 2001)

An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading if it contains a representation or suggestion, not approved for use in the labeling, that a drug is better, more effective, useful in a broader range of conditions or patients than has been demonstrated by substantial evidence.  In the press release dated January 10, 2001, Novartis states “Supporting the filing was a Phase Ill randomized controlled trial of 324 postmenopausal women with large localized or locally advanced breast cancer tumors who were given Femara or tamoxifen as pre-operative treatment to reduce tumor size before breast-conserving surgery.  Clinical responses after four months of preoperative therapy were significantly better for Femara than for tamoxifen (55% versus 36%). ” Femara is not approved for “pre-operative treatment to reduce tumor size before breast-conserving surgery” and, therefore, this statement broadens the indication for Femara and promotes an unapproved new use. 

Journal Advertisement (Oncology 2000; 14(1 1):1 522)

Your journal advertisement lacks fair balance, inadequately communicates the approved indication, and fails to provide information in brief summary as required for prescription drug advertisements.  Specifically, the advertisement makes the claim “Soon there will be a significant change in the way you look at hormonal therapy” but fails to provide information regarding the risks associated with the use of Femara.  For example, the approved product labeling (APL) warns that Femara may cause fetal harm when administered to pregnant women.

Furthermore, this journal advertisement fails to provide the approved indication for use of Femara (i.e., the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  This required information was not communicated in any part of your journal advertisement.

Lastly, regulations require that advertisements for prescription drugs present a true statement of information in brief summary relating to side effects, contraindications and effectiveness. Your journal advertisement does not contain any of this required information.

Novartis should immediately cease distribution of these and other similar promotional materials for Femara that contain the same or similar claims or presentations.  Novartis should submit a written response to DDMAC on or before February 16, 2001, describing its intent and plans to comply with the above. In its letter to DDMAC, Novartis should include the date on which this and other similarly violative materials were discontinued.

Novartis should direct its response to me by facsimile at (301) 594-6771 or by written communication at the Division of Drug Marketing, Advertising and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.  In all future correspondence regarding this matter, please refer to MACMIS ID 9583 in addition to the NDA number.  DDMAC reminds Novartis that only written communications are considered official.

Sincerely,

Joseph A. Grillo, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
      Advertising and Communications