Released by FDA: 8/2/01.  Posted by FDA:  8/10/01

Anthony J. Corrado 
Program Director 
Drug Regulatory Affairs 
Roche Laboratories, Inc. 
340 Kingsland Street 
Nutley, New Jersey 07110-1199

Re:   NDA # 20-697
        Tasmar (tolcapone) Tablets 
        MACMIS # 10175

Dear Mr. Corrado;

This letter notifies Roche Laboratories, Inc. (Roche) of violative promotional materials for Tasmar (tolcapone) Tablets.   These materials are in violation of the Federal Food, Drug, and- Cosmetic Act and applicable regulations because they contain misleading claims and lack risk information.  The violative materials include physician starter packs, bottle holders and packers (ID #s 26106877-1197, 25708261-0897, 25910458-1197, and 25708282-0697).

Specifically, the Division of Drug Marketing, Advertising, and Communications (DDMAC) objects to the following:

Misleading Claims

"Introducing..."

Tasmar was launched m April 1998. This "introducing" claim is misleading because Tasmar is not a new drug and its introduction period is over.

"The first and only COMT inhibitor" 
"Completely new kind..."

Since, a new COMT inhibitor was approved in October 1999, Tasmar has not been the only COMT inhibitor.  Thus, it is misleading to refer to Tasmar as "the first and only..."   Similarly, Tasmar is not a "completely new kind of treatment for Parkinson's Disease."

Lack of Fair Balance

The cited Tasmar promotional materials have insufficient risk information to balance the claims about the drug.  Tasmar is a second line drug for Parkinson's Disease, and has a boxed warning about the risk of fatal, acute fulminant liver failure and the need for patient monitoring.  This important risk information is not presented in the materials.  In addition, the statement "as with all drugs, side effects may occur with Tasmar" is not adequate as fair balance and minimizes the risks associated with Tasmar.

Failure to File

Our records indicate that these promotional materials have not been submitted to DDMAC on FORM FDA 2253 as stipulated in 21 CFR §314.81 (b)(3)(1) that states that the sponsor shall submit all labeling and advertising at the time of initial dissemination.

Requested Actions

To address these objections, DDMAC requests that Roche:

1.  Immediately discontinue the use of these starter kit and sample materials, as well as any other promotional material and practices with the same or similar messages.

2.  Respond to this letter by August 16, 2001.  Your response should include a statement of your intent to comply with the above, a list of all promotional materials with the same or similar issues, and your methods for discontinuing these promotional materials.

3.  Review all disseminated promotional material and submit outstanding materials to DDMAC on Form FDA 2253, as required.

If you have any questions or comments, please contact Dr. Lisa Stockbridge 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 # 10175 in addition to the NDA number.

Sincerely,

 

Lisa L. Stockbridge, Ph.D. 
Regulatory Reviewer 
Division of Drug Marketing, 
    Advertising and Communications