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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Greer®30,000 AU/mL Standardized Mite Extract Brochure - Untitled Letter

 

April 12, 2012
 
VIA FACSIMILE AND USPS
 
Luba Skibo
Senior Director of Regulatory Affairs
Greer Laboratories, Inc.
639 Nuway Circle NE
PO Box 800
Lenoir, NC 28645
 
Re: BLA STN# 101844/5079
Standardized Mite Extract
       Greer®30, 000 AU/mL Standardized Mite Brochure (MPN 100911H433)
 
Dear Mrs. Skibo:
 
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's
(FDA) Center for Biologics Evaluation and Research (CBER) reviewed the “Greer®30,000 AU/mL Standardized Mite Extract” brochure (MPN 100911H433) that you submitted on December 22, 2011 under cover of Form FDA 2253.
 
The brochure is false and misleading because it omits risk information and appears to have been disseminated without adequate directions for use. Therefore, your promotional material is violative and misbrands the above-referenced product under Sections 502(f), 502(n), and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(f), §352(n), §321(n), and FDA implementing regulation, 21 CFR 201.100(d)(1).
 
Background
 
According to the FDA-approved professional labeling (PI), Standardized Mite Extract (Dermatophagoides farinae, Dermatophagoides pteronyssinus, and mixture concentrate) is indicated for the diagnosis of skin test reactivity to dust mite allergen and for treatment of mite-induced allergic asthma, rhinitis, and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity. 
The Boxed Warning of the PI states:
 
WARNING: ANAPHYLAXIS
 
  • Do not inject intravenously
  • Allergenic extracts may cause severe life-threatening systemic reactions, including the rare occurrence of anaphylaxis or death
  • Intended for use only by experts experienced in administering allergic extracts and trained to provide emergency treatment
  • Initial dose must be based on skin test
  • Observe patients in the office for at least 30 minutes following treatment.  Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction
  • Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction

The Warnings and Precautions section of the PI includes, but is not limited to, the following risks:

 
All concentrates of Standardized Mite Extracts can cause serious systemic reactions of varying degrees of severity, including anaphylactic shock and death. Because of the danger of serious reactions, caution is required in testing and treating high risk patients and those with medical conditions that reduce their ability to survive a serious systemic adverse event.
 
Patients should be kept under observation for a minimum of 30 minutes after receiving allergenic extracts so that any adverse reaction can be observed and properly handled.
 
The Adverse Reactions section includes, but is not limited to, the following:
 
Systemic reactions consist primarily of allergic symptoms, such as, generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death. 
 
Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy.

 

Omission of Risk Information
 
Your brochure is misleading because there is no risk information included along with the presentation about the indication (use) of Standardized Mite Extract:
 
GREER Standardized Mite (Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for:
 
-skin test diagnosis of mite allergy
 
-treatment of patients with mite-induced allergic asthma, rhinitis, and conjunctivitis.
 
For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae (D. farinae) or Dermatophagoides pteronyssinus (D. pteronyssinus) based on their clinical history, allergen exposure history, and skin test reactivity.
 
The omission of the risk information misleadingly suggests that there are no safety risks, when in fact such is not the case.
 
Moreover, the brochure, as submitted, appears to be disseminated without a PI. The failure to provide the PI along with the sales aid would render Standardized Mite Extract misbranded within the meaning of section 502(f) of the Act.  See 21 U.S.C. §352 (f); 21 C.F.R. 201.100(d)(1).
 
Conclusion and Requested Actions
 
For the reasons discussed above, your promotional material misbrands Standardized Mite Extract under Sections 502(f), 502(n), and 201(n) of the Act, 21 U.S.C. §352(f), §352(n), §321(n), and FDA implementing regulation, 21 CFR 201.100(d)(1).
 
We request that Greer Laboratories, Inc., immediately cease the dissemination of this violative promotional material for Standardized Mite Extract, as well as promotional materials with the same or similar claims and representations. Please submit a written response within ten (10) business days from the date of this letter.  In your response, state whether you intend to comply with this request, listing all violative promotional materials for Standardized Mite Extract, and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, Ph. D., Branch Chief at the Food and Drug Administration, 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 NDA number. We remind you that only written communications are considered official responses.
 
We also note that the referenced promotional material was submitted under the Biologics License Application (BLA) for Pollen-Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia and not under the appropriate BLA for Standardized Mite Extract. Please ensure that future promotional materials are submitted under the appropriate BLA. 
 
The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for Standardized Mite Extract comply with each applicable requirement of the Act and FDA implementing regulations.
 
 
Sincerely,
 
 
 /s/
 
Robert A. Sausville
Director
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research