Released by FDA: 11/28/00.  Posted by FDA:  12/6/00

Mary Alice Dankulich 
Associate Director 
Worldwide Regulatory Affairs 
Wyeth-Ayerst Research 
P.O. Box 8299 
Philadelphia, PA 19101-8299

Re:   NDA [confidential, deleted by FDA] 320-987 
        Protonix I.V. (pantoprazole sodium) for Injection 
        Protonix (pantoprazole sodium) Delayed-Release Tablets 
        MACMIS ID #9542

Dear Ms. Dankulich:

This letter concerns violative promotional activities by Wyeth-Ayerst Laboratories (WA) for its unapproved product, Protonix IV., and its approved product, Protonix Tablets.  As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has determined that WA promoted Protonix I.V. as safe or effective prior to the product’s approval and promoted Protonix Tablets for unapproved uses.  This promotion is in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations.  Specifically, we object to the following:

Pre-approval Promotion Panel

WA promoted Protonix I.V. prior to approval in the commercial exhibit area at the October American College of Gastroenterology (ACG) Annual Scientific Meeting in New York City.  In the commercial exhibit area, WA displayed a lighted panel with the name “PROTONIX IV. (pantoprazole sodium for injection)."  The panel included a picture of a stomach in the “O” of  “Protonix” with an I.V. bag background and a banner that stated “approval expected soon.”   This panel is violative because it makes a conclusion about the safety or efficacy of the product.

In addition, WA failed to reveal facts that are material in light of the representation made about Protonix I.V.  The product has not been approved by the FDA due to [confidential, deleted by FDA].

Other Violative Promotional Activities and Materials in the Commercial Exhibit Area

WA disseminated materials in the commercial exhibit area for Protonix I.V. prior to approval.  These materials included three company talk papers that compared Protonix I.V. with Protonix Tablets, discussed the use of Protonix I.V. for upper gastrointestinal (UGI) bleed, and discussed the use of Protonix I.V. and tablets in the treatment of Zollinger-Ellison Syndrome (ZES).  These materials made conclusions about the safety or efficacy of Protonix I.V. prior to approval and promoted unapproved uses for the tablet formulation.  Further, WA failed to reveal facts that are material in light of the representations made about Protonix I.V.  WA failed to provide information about [confidential, deleted by FDA].

Other Pre-Approval Promotion

WA is also promoting Protonix I.V. prior to approval by disseminating a reprint entitled “Pantoprazole: A new benzimidazole proton pump inhibitor for oral and administration.” This reprint makes conclusions about the safety or efficacy of Protonix I.V. for a wide-range of non-approved diseases such as eradication of Helicobacter pylori, gastric and duodenal ulcers, and ZES.  The reprint also promotes Protonix Tablets for unapproved uses.

Requested Action

DDMAC requests that WA immediately cease the violative promotion as explained in this letter.  WA should submit a written response to DDMAC, on or before December 12, 2000, describing its intent and plans to comply with our request.  In its response to DDMAC, WA should include a list of all promotional materials that were discontinued, and the discontinuation date.

WA should direct its response to Patricia Staub by facsimile at (301) 594-6759, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857. 

In all future correspondence regarding this matter, please refer to MACMIS #9542 and NDA [confidential, deleted by FDA] 20-987.

Sincerely,

 

Patricia Kuker Staub, RPh, JD. 
Regulatory Review Officer 
Division of Drug Marketing, 
 Advertising, arid Communications