Released by FDA: 1/28/00.  Posted by FDA:  7/24/00

Robert J.Mandetta 
Associate Director, Regulatory Affairs 
Knoll Pharmaceutical Company 
3000 Continental Drive-North 
Mount Olive, NJ 20728

RE:    Synthroid (levothyroxine sodium) Tablets 
          MACMIS ID# 8601

Dear Mr. Mandetta:

Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a note pad being distributed by Knoll representatives to physicians.  The pages of the note pad show a background of Synthroid tablets in each of the available potencies; a header of “The Measure of Excellence” and “Synthroid (Levothyroxine Sodium Tablets, USP)”; and a footer of “The Trusted Standard in Thyroid Hormone Replacement.”  DDMAC has reviewed the material and has determined that it is in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  Specifically, DDMAC objects to the piece for the following reasons:

1. The labeling of Synthroid contains a boxed warning relating to a serious risk associated with the use of the drug product.  Therefore, reminder advertisements for Synthroid are not permitted.  To satisfy the requirement for fair balance, each page would require a presentation of risk information with a prominence and readability reasonably comparable to the information relating to effectiveness.
   
   
2. The header and footer of each page suggests an unsupported superiority claim. Unsubstantiated superiority claims are not permitted.
   
   
3. Use of the term “standard” is misleading given the current status of levothyroxine sodium products.  Neither Synthroid nor any other levothyroxine sodium products have been approved or recognized as a standard in thyroid hormone replacement.  For further information about the status of these products, we refer you to 62 Fed. Reg. 43535-38 (August 14, 1997) (Prescription Drug Products; Levothyroxirie Sodium). 

To address this issue, Knoll should immediately discontinue the dissemination of this and all other promotional materials that contain the same or similar violations. Knoll should respond to this letter with a list of all similarly violative promotional materials and your proposed method foi discontinuing their use.  Your response should be received by this office no later than ten days from the receipt of this letter.  It should be directed to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.  DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #8601.

Sincerely,

Margaret M. Kober, RPh. 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising and Communications