Released by FDA: 4/4/00.  Posted by FDA:  4/19/00

David Garbe 
Director, Scientific Information and Medical Compliance 
Allergan, Inc. 
2525 DuPont Drive IL-1L 
P0 Box 19534 
Irvine, CA 92623-9534

RE:   NDA  21-009 
        Alocril (nedocromil sodium ophthalmic solution), 2% 
        MACMIS # 8809

Dear Mr. Garbe:

This letter describes Allergan, Inc.’s (Allergan) violative promotional materials for Alocril submitted February 29, 2000, under cover of Form FDA 2253.  The submission included a Dear Doctor letter, two sales aids (AL9172 and AL9245), a fold-out brochure titled, “The Chain of Ocular Itch in Allergic Response Is About To Be Broken,” and a journal advertisement.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed these promotional materials and concluded that they are false or misleading under the Federal Food, Drug, and Cosmetic Act and its implementing regulations because they contain unsubstantiated claims and dc-emphasize risk information.  Our specific objections follow:

Misleading Classification

In the Dear Doctor letter, you claim that Alocril is a new class of mast cell stabilizer (emphasis added).  This claim is misleading because it is not supported by adequate evidence.  Alocril’s approved product labeling states that nedocromol sodium [Alocril] is a mast cell stabilizer.  Alocril’s description from the clinical pharmacology section of the approved product labeling is similar to other marketed products with mast cell stabilizing properties that alleviate itching due to allergic conjunctivitis.  Thus, to imply that Alocril is a new class of mast cell stabilizer without adequate evidence is misleading.

Unsubstantiated Comparison

In many of the promotional materials¹, you claim that in a comparative study of symptomatic relief in cat-sensitive individuals (n=20), Alocril provides symptomatic relief as fast as Patanol.  This claim is misleading because it is not supported by substantial evidence.  You have referenced an active controlled study in 20 patients using olepatadine hydrochloride 0.1 % and 2% nedocromil sodium to assess burning and itching.  This study is inadequately designed and powered to support your claim that Alocril and Patanol have similar speeds of effectiveness.

Fair Balance

The promotional materials lack fair balance because 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 the effectiveness of the drug. For example:

Brochure AL9245 - Although information is presented regarding the side effects seen with Alocril, this information is presented less prominently than your claims of efficacy. For example, the most detailed information is placed inconspicuously in paragraph format on the bottom of the last page of the brochure below the. company information and product logo.  However, the efficacy information is presented in easy-to-read short bulleted statements.

Advertisement - The risk information is presented in block, running text and is placed on the bottom of the page of the advertisement below the company information and product logo.

Dear Doctor Letter - The risk information is presented in block, running text and is placed on the bottom of the page below the Director of Marketing’s - signature block.

Requested Action

Because of these unsubstantiated claims and lack of fair balance, we request that you immediately cease the dissemination of these violative promotional materials and any other violative promotional materials that lack fair balance and/or make false or misleading claims regarding Alocril.  You should respond to me regarding this violation by April 18, 2000, providing a list of the promotional materials discontinued and the date Allergan ceased the dissemination of the promotional materials.

If you have any questions, please contact me by facsimile at (301) 594-6771, or write to me at the Division of Drug Marketing. Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857.  We remind you that only written. communications are considered official.

In all future correspondence regarding this matter, please refer to MACMIS # 8809 and NDA 2 1-009.

Sincerely,

Warren F. Rumble 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications

^1.  Brochures AL9245 and AL9172, Dear Doctor letter, and unnumbered advertisement