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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Antihemophilic Factor (Human), Alphanate

November 27, 2002

Ms. Amy Feliciano
Associate Director of Regulatory Affairs
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032

Dear Ms. Feliciano:

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, Alphanate (Antihemophilic Factor (Human)), that violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. APLB has reviewed a journal advertisement (ad) that has been published in at least two recent issues of HemAware and believes that this ad contains false claims about Alphanate. A copy of the referenced ad is enclosed.

False and Misleading

21 CFR 202.1(e)(6)(i) states that an advertisement is false.or otherwise misleading, if it contains a representation or suggestion, not approved or permitted for use in the labeling that a drug, ., is more effective, useful in a broader range of conditions or patients, than has been demonstrated by substantial evidence or substantial clinical experience.. CBER is unaware of any evidence or clinical experience that Alphanate is effective or useful in treating von Willebrand disease.

Your ad, published in the July/August and September/October 2002 issues of HemAware, presents, on a single page:

  • the name of your product, Alphanate;
  • a line of text that states, in its entirety: "Factor VIII/von Willebrand Factor;" and
  • a line of text that states, in its entirety: "A New Horizon. A New Direction."

However, Alphanate is "indicated for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency." The approved package insert further states that, "No clinical trials have as yet been conducted using Alphanate for treatment of von Willebrand's disease, therefore the product is not approved for this use."

Your ad specifically suggests an unapproved indication for use for your product by the inclusion and juxtaposition of the text "von Willebrand Factor" and "A New Horizon. A New Direction." There is no other reason for the reference, "von Willebrand Factor." 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 each requirement of the Act and applicable regulations.

You should respond 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 these promotional materials.

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. Glenn N. 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