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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GenTrac, Inc 01-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville MD 20852-1448

November 1, 2005

CBER-06-001

VIA FACSIMILE AND CERTIFIED MAIL

RETURN RECEIPT REOUESTED

WARNING LETTER

Mr. Michael Barrett
GenTrac, Incorporated.
501 5th Street
Bristol, Tennessee 37620

Re: BLA STN # 102865
THROMBIN-JMI® [Thrombin, Topical, U.S.P. (Bovine Origin)]

Dear Mr. Barrett :

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) has reviewed a Thrombin Burn Surgery Video and a THROMBIN-JMI Note Pad (copies enclosed) for THROMBIN-JMI ® [Thrombin, Topical, U.S.P. (Bovine Origin)] submitted under cover of Form FDA 2253. The video fails to reveal material facts regarding the risks associated with the use of THROMBIN-JMI. The note pad constitutes impermissible reminder labeling. As a result, the materials violate section 502(a) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. 352(a) and encourage the potentially unsafe use of THROMBIN-JMI.

Background

According to the FDA-approved professional labeling (PI), THROMBIN-JMI is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. Thrombin-JMI is manufactured by GenTrac, Incorporated, Middleton, Wisconsin and distributed by Jones Pharma Incorporated, Bristol, VA. Jones Pharma Incorporated and GenTrac, Incorporated are wholly owned subsidiaries of King Pharmaceuticals, Inc. The PI states that, "THROMBIN-JMI is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible."

The PI also contains detailed risk information such as contraindications; warnings, including a black box warning; precautions; and adverse reactions. The black box warning concerns the association between bovine thrombin preparations and abnormalities in hemostasis, including severe bleeding or thrombosis, apparently related to "the information of antibodies against bovine thrombin and/or factor V."

Failure to Reveal Material Facts

The video includes the indication for THROMBIN-JMI but does not provide complete risk information. The video includes a written warning, from the PI, that THROMBIN-JMI must not be injected or otherwise allowed to enter large blood vessels because "[e]xtensive intravascular clotting and even death may result." However, the video does not include information from the black box warning, contraindications or adverse reaction 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 section 201(n) of the Act, 21 U.S.C. 321(n). Cf 21 C.F.R. 202.1(e)(3)(i).

Violative Reminder Labeling

The THROMBIN-JMI Note Pad constitutes reminder labeling for your product. However, according to 21 C.F.R. 201.100(f), reminder labeling, other than price information, is not permitted for a prescription drug product whose labeling contains a boxed warning relating to a serious hazard associated with the use of the drug product. As a result, the note pad misbrands your product within the meaning of section 502(f) of the Act. 21 U.S.C. 352(f).

Conclusion and Requested Actions

Your video misbrands THROMBIN-JMI within the meaning of section 502(a) of the Act because it fails to reveal material facts regarding the risks associated with the use of this product. In addition, the note pad misbrands THROMBIN-JMI within the meaning of section 502(f) of the Act. 21 U.S.C. 352(a), 352(f).

OCBQ requests that GenTrac, Incorporated immediately cease the dissemination of violative promotional materials for THROMBIN-JMI 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 THROMBIN-JMI such as those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we request, further, that your submission include a plan of action to disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative promotional material. (see . 21 CFR 200.5(c)(3)). Please direct your response to me at 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 and to CBER-06-001. We remind you that only written communications are considered official responses.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for THROMBIN-JMI comply with each applicable requirement of the Act and FDA's implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Sincerely,
/s/

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