• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Rho(D) Immune Globulin Intravenous (Human), WinRho SDF

May 30, 2003

Mr. Andrew Storey
Cangene Corporation
104 Chancellor Matheson Road
University of Manitoba
Winnipeg, Manitoba Canada R3T 5Y3

Dear Mr. Storey:

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, WinRho SDF (Rho(D) Immune Globulin Intravenous (Human)), that violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. APLB has reviewed a journal ad, (07063-80-GEN-190702, Tab A), and a handout, (7062-80-GEN-100702, Tab B) and finds them false and/or misleading. A copy of the referenced items are enclosed.

Safety

  1. Your journal ad and handout are false and/or misleading because they contain:

    1. a drug comparison that represents or suggests that WinRho SDF is safer than another drug, and
    2. a representation or suggestion that a drug is safer than has been demonstrated by substantial evidence or substantial clinical experience, 21 CFR § 202.1 (e)(6)(ii) and (iv), respectively.

    These items are further misleading because they use tables or graphs to distort or misrepresent the relationships, trends, differences, or changes among the variables or products studied so that the graph creates a misleading impression, 21 CFR § 202.1 (e)(7)(iv).

    The journal ad and handout include a table entitled, "Reduces the occurrence of side effects in the treatment of childhood acute ITP." This table presents a comparison between WinRho SDF and "High-dose IVIG" for three common adverse events: headache, fever and chills. The sample size was extremely small (n=3 vs. n=9, respectively) and is referenced as data on file. Such minimal data do not constitute substantial evidence or substantial clinical experience, and as a result, the table and claims are false and/or misleading.

    In sharp contrast to the small sample size promoted in the journal ad and handout, the approved package insert references a clinical trial for childhood acute ITP consisting of a multicenter, randomized, controlled trial of WinRho SDF compared to high dose and low dose Immune Globulin Intravenous (Human) and prednisone in 146 children. It is inappropriate and misleading to ignore these comparative data in your presentation of risks. You should immediately cease any further dissemination of all advertising and promotional materials that contain these claims and similar presentations.

     

  2. Your journal ad and handout are false and/or misleading 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., 21 CFR § 202.1 (e)(7)(viii).

     

    The journal ad and handout minimize important risk information by the presentation of bolded warnings from the approved package insert in extremely tiny print at the bottom of each page. The font size and contrast with the background color are not reasonably comparable with the presentation of effectiveness information and are very difficult to read. You should immediately cease any further dissemination of all advertising and promotional materials that contain similar presentations and revise them to ensure that all important risk information be presented in fair balance to effectiveness information.

Effectiveness

  1. Promotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience. 21 CFR § 202.1 (e)(6)(ii). Your journal ad and handout are misleading because they present comparative efficacy claims for WinRho SDF that are not supported by substantial evidence or substantial clinical experience.

    The journal ad and handout include a figure entitled, "WinRho SDF raises platelet levels fast (emphasis added) in acute childhood ITP (N=27)." This figure presents a comparison between WinRho SDF and "Pooled IVIG", in which the sample size was extremely small (n=14 vs. n=13, respectively). These data do not constitute substantial evidence or substantial clinical experience and, in fact, are clearly labeled as not statistically different. The referenced journal article concludes that, "in this retrospective analysis anti-D [WinRho SDF] was as effective as IVIg for the treatment of acute ITP in children." As a result, your claim that, "WinRho SDF raises platelet levels fast," is unsupported by the data.

    In sharp contrast to the small sample size promoted in the journal ad and handout, the approved package insert references a clinical trial for childhood acute ITP consisting of a multicenter, randomized, controlled trial of WinRho SDF compared to IGIV in 146 children. It is inappropriate to ignore these comparative data in your presentation of effectiveness. You should immediately cease any further dissemination of all advertising and promotional materials that contain these claims and similar presentations.

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.

You should respond in writing to us within ten (10) business days of the date of this letter. Your response should include your intent to comply with the above request, a list of all violative materials with the same or similar messages, and your method for discontinuing their use.

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 Mr. Byrd at 301-827-3028.

Center for Biologics Evaluation and Research
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

Sincerely,

----- signature -----

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

Enclosures