Released by FDA: 3/26/01.  Posted by FDA:  3/28/01

Priya Jambhekar 
Director, Regulatory Affairs 
Baxter Pharmaceutical Products Inc. 
95 Spring Street 
New Providence, New Jersey 07974

RE:   NDA #19-368 
         Brevibloc (esmolol hydrochloride) Injection 
         MACMIS ID # 9860

Dear Ms. Jambhekar:

This letter concerns Baxter Pharmaceutical Products Inc.’s (BPP) dissemination of promotional materials for Brevibloc.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a calendar (748285) for Brevibloc as part of its routine monitoring and surveillance program.  From its review, DDMAC has concluded that this piece is in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations because it lacks fair balance.

Lack of Fair Balance

Promotional materials are lacking in lair balance if they fail to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other technique apt to achieve emphasis.

Your calendar lacks fair balance because it includes efficacy claims that are prominently presented with bullets, white space, and large headings.  In contrast, the majority of your risk information is presented in a small font size and block format, with minimal white space and without headings or other means of signaling the reader specifically to important warnings and contraindications.  In addition, you fail to disclose the warning that Brevibloc should not be used as the treatment for hypertension in patients in whom the increased blood pressure is primarily due to the vasoconstriction associated with hypothermia.

We refer you to our untitled letter dated October 1, 1999, in which we outlined similar objections to violative materials and your October 15, 1999, response to our untitled letter stating that you would discontinue violative materials and correct the misleading risk presentation in future promotional pieces.

Furthermore, your calendar includes the efficacy claim “In Clinical studies, about 60- 70% of patients treated with Brevibloc achieved a desired therapeutic effect.”  Presenting this efficacy claim as the first bullet introducing your risk information minimizes the importance of the contraindications, warnings, precautions, and adverse reactions associated with Brevibloc therapy that follow.

BPP should immediately cease dissemination of promotional materials or activities that contain these and similar claims or presentations concerning Brevibloc.  In addition, BPP should respond in writing no later than April 9, 2001, describing its plan to comply.  BPP should also include a list of materials being discontinued, as well as the date of discontinuation.

Your response should be directed to me 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.

We remind you that only written communications are considered official. In all future correspondence regarding this particular mailer please refer to MACMIS ID #9860 in addition to the NDA number.

Sincerely,

Andrew S.T. Haffer, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising, and Communications