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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Antihemophilic Factor (Recombinant) Formulated with Sucrose, Kogenate FS

VIA FACSIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED

January 23, 2006

Carol M. Moore
Vice President, Worldwide Regulatory Affairs
Bayer HealthCare LLC
800 Dwight Way
Berkeley, CA 94701-1986

Re: BLA STN #103332
      Kogenate FS [Antihemophilic Factor (Recombinant) Formulated with Sucrose]

Dear Ms. Moore:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed a number of promotional pieces for Kogenate FS [Antihemophilic Factor (Recombinant) Formulated with Sucrose] submitted under cover of Form FDA 2253: Free Trial Program Key Message & Q & A (09705Y), Free Trial Program Letter for Kogenate Users (06225Y), Free Trial Program Letter for Customers (096215Y), and Free Trial Program Letter for Healthcare Professionals (06205Y). These promotional materials are misleading because they fail to reveal material facts regarding the risks associated with the use of Kogenate FS and, therefore, misbrand Kogenate FS under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) and 321(n). The letters were also apparently disseminated without adequate directions for use, in violation of section 502(f) of the Act. By failing to include sufficient information on risks and adequate directions for use, you have encouraged the potentially unsafe use of Kogenate FS.

Background

According to the FDA-approved professional labeling (PI), Kogenate FS is a dried concentrate preparation of Antihemophilic Factor produced by Baby Hamster Kidney cells into which the human factor VIII gene has been introduced. The manufacturing of Kogenate FS incorporates a revised purification and formulation with sucrose that eliminates the addition of Albumin (Human). Kogenate FS is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor FVIII.

The PI also includes the following detailed risk information including contraindications, and adverse reactions:

Kogenate FS is contraindicated in individuals with a previous hypersensitivity to constituents of the preparations or known hypersensitivity to mouse or hamster proteins. The most common adverse events include: injection site reactions, dizziness, and rash.

Failure to Reveal Material Facts

The Free Trial Program document and the various letters provide indication for use and patient population information but fail to provide any risk information. This omission of risk information results in your product being misbranded within the meaning of section 502(a) of the Act. 21 U.S.C. 352(a). See also section 201(n) of the Act, 21 U.S.C. 321(n). The letters also fail to provide adequate directions for use, because they were apparently disseminated without a PI. Such an action renders your product misbranded within the meaning of section 502(f) of the Act, 21 U.S.C. 352(f). See 21 CFR 201.100(d)(1).

Conclusion and Requested Actions

Your Free Trial Program document and various letters misbrand Kogenate FS within the meaning of sections 502(a) of the Act because they fail to reveal material facts regarding the risks associated with the use of this product and are, therefore, misleading. 21 U.S.C. 352(a). In addition, the letters were disseminated without adequate directions for use and render your product misbranded within the meaning of section 502(f) of the Act, 21 U.S.C. 352(f).

OCBQ requests that Bayer HealthCare, LLC immediately cease the dissemination of violative promotional materials for Kogenate FS such as those described above. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for Kogenate FS such as those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. We remind you that only written communications are considered official responses. If you choose to revise your promotional materials, the Advertising and Promotional Labeling Branch 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.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Kogenate FS comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,

----- signature -----

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

Enclosures
A     Free Trial Program Key Message & Q & A
B     Free Trial Program Letter for Customers
C     Free Trial Program Letter for the Hemophilia Community
D     Free Trial Program Letter for Healthcare Professionals