January 23, 2003
Mr. Leonard M. Baum, R.Ph.
Aventis Behring L.L.C.
1020 First Avenue
King of Prussia, PA 19406-1310
Dear Mr. Baum:
Through routine monitoring and surveillance, The Advertising and Promotional Labeling Branch (APLB) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has identified promotional materials for your product, Gammar-P I.V. (Immune Globulin Intravenous (Human)), that violate the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. APLB has reviewed professional print material and finds that it contains statements that are misleading. A copy of the referenced brochure is enclosed.
The following statements from the back cover of the brochure in Tab A represent comparative safety claims that mislead the reader to believe that pasteurized IGIV products are safer than non-pasteurized IGIV products.
You state that, "Pasteurization is more effective than solvent/detergent in reducing the risk of viral transmission" and "Pasteurization inactivates certain non-lipid enveloped viruses that can be resistant to the solvent/detergent method." It is not sufficient to declare pasteurization to be more effective simply because it may inactivate certain non-enveloped viruses. Solvent/detergent viral inactivation has its own unique advantages. For example, it is more effective than pasteurization in the inactivation of hepatitis C and related model viruses and it is more robust than heat treatment.
If you have data consisting of substantial evidence or substantial clinical experience to support your claims, please submit the data, within 10 days of the date of this letter, to CBER for review. In the absence of such data, you should immediately discontinue any further use of these phrases in all advertising and promotional materials.
- Your ad prominently displays the statement, "Pasteurized. For safety's sake." This statement misleadingly implies that if a product is not pasteurized, it is not safe. You should immediately cease any further dissemination of all advertising and promotional materials that contain these claims and similar presentations.
- The contraindications and the warning (definition of pasteurization), embedded in the paragraph of risk information on the back cover of the brochure, lack sufficient emphasis and thus minimizes this important risk information. You are requested to emphasize the contraindications and the warning. An acceptable way to do this would be to reduce the type size of the font for "Pasteurized" (top of back cover) to that of "Pasteurization of Gammar-P I.V.." and increase the type size of the definition of pasteurization (see asterisk near bottom of back cover) to ensure that all of these statements have reasonably comparable size and prominence.
In addition to the statements above, FDA is concerned about the following:
On the cover page of the enclosed brochure, there is a table that compares Gammar-P.I.V. and ZLB's IGIV. As it currently stands, the table appears to lack certain useful information. We recommend that this table be revised to:
- identify the population from which the half-life data in the comparison table are derived (i.e., were these PID patients or Normal Volunteers), and
- identify the types of viruses and log reduction for each step.
This letter is not intended to be an all-inclusive list of deficiencies associated with your promotion of the above product. It is your responsibility to ensure that all materials distributed within the United States are in conformance with the requirements of the Act and applicable regulations.
Please respond in writing within 10 days of the date of this letter. Your response should include a statement of your intent to comply with each of the above, a list of all promotional materials that were discontinued, if any, and the discontinuation date.
Your response should be directed to Mr. Glenn N. Byrd, Chief, APLB, at the address listed below. Should you have any questions or concerns involving this matter, please contact Ms. Kathryn D. Smith, Regulatory Review Officer at (301) 827- 3028.
Office of Compliance and Biologics Quality
Division of Case Management
Advertising and Promotional Labeling Branch, HFM-602
1401 Rockville Pike, 200S
Rockville, MD 20852-1448
----- signature -----
Mary A. Malarkey
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research