Violative Advertising and Promotional Labeling Letter

Interferon beta-1a, Rebif (Serono Laboratories, Inc)

June 18, 2003

Mr. Thomas A. Lang
Serono Laboratories, Inc.
100 Longwater Circle
Norwell, MA 02061

Dear Mr. Lang:

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 material for your product, Rebif (Interferon beta-1a) that violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. We reviewed advertisements on your website, www.serono.com, as well as a professional print ad (02-19263), “The only one with the benefit of all 3,” and conclude that they lack fair balance and are misleading because important risk information is omitted and /or minimized.

Website (www.serono.com)

1. Certain advertisements on this website are misleading because they completely omit information regarding the risks associated with the use of Rebif. Copies of the referenced web pages are enclosed.
   1. The first web page under the header, “Our Products - Multiple Sclerosis,” includes text discussing the efficacy of Rebif but omits all information regarding the risks associated with the use of Rebif.

   2. On the subsequent “Rebif” page, the proprietary name Rebif 44 mcgx3 is prominently displayed on left side of the page. The accompanying text discusses the efficacy of Rebif but omits all information regarding the risks associated with the use of Rebif.

   3. On the same “Rebif” page, the proprietary name appears as Rebif 44mcgx3 in bold lettering with the established name beneath it in extremely small print. This page fails to present the established name in letters that are at least half as large as the letters comprising the proprietary name, 21CFR 202.1(b)(2), and fails to display the name of at least one specific dosage form, 21 CFR 202.1 (d)(2).

   You should immediately revise your website to ensure that important risk information is provided in comparable depth and detail to effectiveness information. You should also correct the presentation of your proprietary name, established name, and dosage form to comply with the regulations.

Professional Print Ad

2. This ad minimizes important risk information by failing to present information about the risks associated with the use of Rebif with the prominence and readability reasonably comparable to the presentation of the information relating to the effectiveness of the drug, taking into account all implementing factors, 21 CFR 202.1(e)(7)(viii). A copy of the ad is enclosed.

   The only risk information included in the four page print ad is presented in small type on the bottom of pages 2 and 3. By contrast, numerous effectiveness claims, are presented in much larger, bold, contrasting color type, for example:

   • “Proven effective in all 3 efficacy measures.”
   • “Significantly reduces MRI lesion activity and area.”
   • “Significantly reduces the frequency of relapses.”
   • “Significantly reduces the accumulation of disability.”

   The presentation of risk information in smaller type across pages 2 and 3 is not reasonably comparable, in either readability or prominence, to the ad’s presentation of Rebif’s effectiveness. You should immediately cease any further dissemination of all advertising and promotional materials that contain similar presentations. In addition, you should revise your materials to ensure proper prominence of approved safety data.

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 each requirement of the Act and applicable regulations.

Please submit a written response within ten (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 with the same or similar issues, and your methods for discontinuing and/or correcting these promotional materials, as applicable.

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. Maryann Gallagher, Consumer Safety Officer, at 301-827-3028.

Sincerely,

----- signature -----

Mary A. Malarkey
Director
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Enclosures

Last Updated: 6/20/2003

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