| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Rockville, MD 20857 |
May 03, 2013
VIA FACSIMILE AND UPS
SmartPractice Denmark AS
Attention: Kim M. Sullivan
U.S. Agent for SmartPractice Denmark AS
3400 East McDowell Road
Phoenix, AZ 85008
Re: BLA STN# 103738/5107
T.R.U.E. TEST® (Thin-Layer Rapid Use Epicutaneous Patch Test)
Dear Ms. Sullivan:
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 following promotional materials that SmartPractice Denmark AS (SmartPractice) submitted on January 17, 2013, under cover of Form FDA 2253, in response to our November 29, 2012, information request to receive promotional materials for T.R.U.E. TEST® (Thin-Layer Rapid Use Epicutaneous Patch Test) at the time of first use:
78199-A_SP Pre-AAD Supercard_lo-res.pdf
78200-A_SP Pre-AAAAI Supercard_lo-res.pdf
78202A-D_SP 4-Panel Pop-Up_Yellow Comp_lo-res.pdf
78202-E and F_TRUE TEST Pull-Up_Lime_lo-res.pdf
78208-B_US Contact Dermatitis Newsletter 3-WEB.pdf
78209-A_TRUE TEST Supercard_lo-res.pdf
78290_TRUE TEST Press Release.pdf
78314_TRUE TEST Manual 2012-Partial_lo-res.pdf
78534-B_TRUE TEST Global-ROW Slick_email.pdf
78550_ACDS TRUE TEST Feedback BRC.pdf
AL2772_78311_True Test Slick_email_5-25-12.pdf
AL2772_78311_True Test Slick_lo-res_5-25-12.pdf
_0 i.ii HOW TO USE THIS MANUAL.pdf
_0 i.iii TRUE TEST Reference Manual_Final_2012.pdf
_0 i.iv True Test Manual Cover-FNL_2012.pdf
_0.1 TITLE PAGES_FNL_2012.pdf
_0.2 TABLE OF CONTENTS_FNL_2012.pdf
_0.3 DISCLAIMER STORAGE_FNL_2012.pdf
_2.0 TT Quick Reference_FNL_2012.pdf
_3.0 Clinical Indications_FNL_2012.pdf
_4.0 TT application_FNL_2012.pdf
_5.0 Patient forms headerFNL_2012.pdf
_5.1 PATIENT HISTORY_FNL_2012.pdf
_5.2 Standard Data Collection Form.pdf
_6.0 Interpret Results_ALL_FNL_2012.pdf
_7.0 Allergen Components_All_FNL_2012.pdf
_9.0 Patient forms headerFNL_2012.pdf
_9.1 TT QandA_FNL_2012.pdf
_9.2_Patient Reading labels_FNL_2012.pdf
_9.3_Patient Negative Reaction_FNL_2012.pdf
_9.4_All Patient Information Sheets_FNL_2012.pdf
With the exception of your final reference manual (78314) and a sales aid (78199-A), your promotional materials are all false or misleading because they omit risk information. This misbrands T.R.U.E. TEST 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). In addition, all of the above referenced promotional materials appear to have been disseminated without adequate directions for use, in violation of section 502(f)(1) of the Act, 21 U.S.C. §352(f)(1). Finally, SmartPractice has failed to submit promotional materials to CBER at the time of initial dissemination, in violation of 21 CFR §601.12(f)(4).
According to the FDA-approved prescribing information (PI), T.R.U.E. TEST is an epicutaneous patch test indicated for use as an aid in the diagnosis of allergic contact dermatitis (ACD) in persons 18 years of age and older whose history suggests sensitivity to one or more of the 35 substances included on the T.R.U.E. TEST panels. The PI presents important risk information for T.R.U.E. TEST.
The CONTRAINDICATIONS section of the PI states:
Do not apply to skin of patients with a history of severe allergic reaction (systemic and/or local) to any of the allergen components or inactive substances of T.R.U.E. TEST.
Do not apply to skin that is injured or inflamed.
The WARNINGS AND PRECAUTIONS section of the PI includes information under the following headings:
5.1 Acute Allergic Reactions
5.3 Extreme Positive Reactions
5.4 Excited Skin Syndrome (Angry Back)
5.5 Tape Reactions
5.6 Irritant Contact Dermatitis
The ADVERSE REACTIONS section includes, but is not limited to the following:
The most common adverse reactions (occurring in greater than 1% of the study population), were burning, tape irritation, persistent reactions, erythema, and hyper/hypo pigmentation.
False or Misleading Promotional Materials/ Omission of Risk Information
Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made or with respect to consequences that may result from the use of the article to which the promotional materials relate under the conditions of use prescribed in the labeling or the advertising. (See sections 502(a) and 201(n) of the Act, 21 U.S.C. §352(a) and §321(n)) The promotional materials described above (with the exception of reference manual 78314 and sales aid 78199-A) fail to provide any information pertaining to the potential risks associated with the use of T.R.U.E. TEST, and hence are misleading.
Lack of Adequate Directions for Use
Your promotional materials, as submitted, appear to be disseminated without a PI. The failure to provide the PI along with the promotional materials would render T.R.U.E. TEST misbranded within the meaning of section 502(f)(1) of the Act. (21 U.S.C. §352 (f)(1))
Failure to Submit Promotional Materials at the Time of Dissemination
Failure to submit promotional materials to FDA at the time of initial dissemination of such materials is a violation of 21 CFR §601.12(f)(4). We have no record of submission of the referenced materials at the time of first use.
Conclusion and Requested Actions
For the reasons discussed above, your promotional materials misbrand T.R.U.E. TEST under Sections 502(a), 201(n), and 502(f)(1) of the Act, 21 U.S.C. §352(a), §321(n), §352(f)(1), and FDA implementing regulation, 21 CFR §601.12(f)(4).
We request that you immediately cease the dissemination of the violative promotional materials described above and other similar materials for T.R.U.E. TEST. Please submit a written response to this letter within ten (10) business days of receipt of this letter, stating whether you intend to comply with this request, listing all promotional materials in use for T.R.U.E. TEST that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Because the violations described above are serious, we further request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.
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 number. We remind you that only written communications are considered official responses. If you choose to revise your promotional materials, we are willing to assist you with your revised materials by commenting on 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 T.R.U.E. TEST comply with each applicable requirement of theAct 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.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research