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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Antihemophilic Factor (Recombinant), ReFacto

February 2, 2004

VIA FASCIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Nanette Holston
Director, Global Brand Management
Wyeth Pharmaceuticals Inc.
E-Doc
500 Arcola Rd.
Collegeville, PA 19426

Re: BLA STN #103779
    ReFacto, Antihemophilic Factor (Recombinant)

Dear Ms. Holston:

The Advertising and Promotional Labeling Branch (APLB) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed information (Material ID Code # 105697-01) on ReFacto, Antihemophilic Factor (Recombinant) (copy enclosed) that you submitted to us on Form FDA-2253 (for submitting advertising or promotional labeling). This information is false or misleading under section 502(n) or 502(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 352(n) or § 352(a)) because it contains an unsubstantiated safety claim.

Background

ReFacto is a purified protein produced by recombinant DNA technology for use in therapy of factor VIII deficiency. It is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). ReFacto is also indicated for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. It does not contain von Willebrand factor and therefore is not indicated in von Willebrand's disease.

Unsubstantiated Safety Claim

The cited material for ReFacto is false or misleading because it contains a safety and superiority claim that, to our knowledge, has not been demonstrated by substantial evidence or substantial clinical experience. Cf. 21 C.F.R. §202.1(e)(6)(i); 21 C.F.R. § 201.6(a).

Specifically, the referenced information contains text that includes a title: "Unsurpassed viral safety," followed by, "Albumin-free final formulation for unsurpassed viral safety." FDA is unaware of any data supporting the claim that your product has better viral safety than any other antihemophilic factor.

Conclusion and Requested Actions

The cited material misbrands ReFacto within the meaning of section 502(n) or 502(a) of the Act (21 U.S.C. § 352(n) or § 352(a)) because it represents that ReFacto is safer than has been demonstrated by substantial evidence or substantial clinical experience and is, therefore, false or misleading.

APLB requests that Wyeth Pharmaceuticals immediately cease disseminating promotional materials for ReFacto that contain claims the same as, or similar to, those described above. Please submit a written response to this letter within 10 business days of the date of this letter, describing your intent to comply with this request, listing all promotional materials for ReFacto that contain claims the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.

If you have data constituting substantial evidence or substantial clinical experience to support your claims, please submit those data to CBER for review.

Please direct your response to Mr. Glenn N. Byrd, Chief, APLB, at the following address:

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
Rockville, MD 20852-1448.

In all future correspondence regarding this matter, please refer to the BLA number. We remind you that only written communications are considered official. Should you have any questions or concerns involving this matter, please contact CDR Nancy Chamberlin, Director Regulatory Review Officer at 301-827-3028.

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 comply with each applicable requirement of the Act and FDA regulations. If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.

Sincerely,

----- signature -----

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

Enclosure