2011-24598. Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of its report of scientific and medical literature and information concerning the use of non-standardized allergenic extracts in the diagnosis and treatment of allergic disease. The report is provided in a data file entitled “Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease.” FDA is making this report available to provide information and obtain comments from public and private stakeholders. FDA will also seek input on the report from the Allergenic Products Advisory Committee (APAC) at a meeting to be held on October 25, 2011. FDA has not made any regulatory decisions concerning the report or the products discussed in the scientific literature and information cited. FDA will review comments and other information it receives, as part of its continued oversight of regulated products.

DATES:

Submit either electronic or written comments on the report by November 25, 2011.

ADDRESSES:

Submit written requests for single copies of the report to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The data file may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the data file document.

Submit electronic comments on the report to http://www.regulations.gov. Submit written comments on the report to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Introduction

FDA is announcing the availability of its report of scientific and medical literature and information concerning the use of non-standardized allergenic extracts in the diagnosis and treatment of allergic disease. FDA is making this report available to provide information and obtain comment on the report from public and private stakeholders. FDA will also seek input on the report from APAC at a meeting to be held on October 25, 2011. A separate notice of the APAC meeting is published elsewhere in this issue of the Federal Register. This process will assist FDA in its continued oversight of regulated products.

II. Discussion

In 2004, FDA formed an internal committee to review available scientific and medical data on the safety and effectiveness of non-standardized allergenic extracts. FDA formed this committee to consider the previous evaluations performed by the external allergenics advisory review panels under 21 CFR 601.25 (Panel I or “Original Panel”) and under 21 CFR 601.26 (Panel II or “Reclassification Panel”). Reports of the Original and Reclassification Panels are available at http://www.fda.gov/​BiologicsBloodVaccines/​Allergenics/​ucm272115.htm. The internal committee designed a data file to use in its review and to archive supporting data. The data file includes a report of information for each product, including a discussion of each product reviewed, and a list of reviewed literature associated with each product. FDA's approach to creating this data file was presented to APAC on April 7, 2005, and discussed again at the APAC meeting on September 13, 2006.

After receiving favorable feedback from the APAC on FDA's proposed methodology, FDA proceeded to collect the following information in order to facilitate its assessment of safety and effectiveness of non-standardized allergenic products.

A. Literature Reviewed by the Allergenics Advisory Review Panels

This includes literature reviewed by the Original Panel as part of its final report in 1981 and literature reviewed by the Reclassification Panel as part of its final report in 1983.

B. Data Concerning the Effectiveness and Safety of Non-Standardized Allergenic Products That Have Become Available Since 1972

This includes published literature, available manufacturer data, and data from other external sources. FDA accumulated these data from the following sources:

1. Published Literature From 1972 to the Present

This literature was acquired by searching for articles using a PubMed and/or Institute for Scientific Information (ISI) search engine (English-language literature articles only).

2. Publicly Available Manufacturer Data

These data were obtained by reviewing information published in the literature.

3. Medwatch Data Collected for Years 1987 to 2010

These data were evaluated for safety related product trends.

4. Data From Other External Sources

These data were obtained by performing a broad Internet search (e.g., Google) to check for any additional safety or effectiveness data not captured in published articles found via PubMed or ISI.

FDA collected information from published scientific and medical literature and other data sources for each extract in order to identify those studies that used acceptable alternative testing methods. FDA also collected information from studies that:

• Provided identifiable, specific and valid nomenclature for the source materials used in the preparation of the allergenic extracts in the studies.
• Were performed using aqueous based extracts prepared from specifically identified source materials with correct nomenclature.
• Described identifiable, specific, and valid study methods.
• Provided objective and evaluable data.
• For skin test data in the studies:

Obtained positive skin tests in index cases by either skin prick or intradermal methods, demonstrated by:

○ Wheal or erythema;

○ Where appropriate, comparison to positive and negative control data in same study subjects.

• For studies with cross reactivity data, demonstrated cross reactivity by:

○ ELISA or RAST inhibition;

○ Western immunoblot; or

○ Other valid immunochemical data.

In reviewing evidence of efficacy, FDA did not consider to be adequate “random experience,” or reports that lacked sufficient scientific detail for proper evaluation (such as imprecise nomenclature). FDA also did not consider to be adequate “isolated case reports” unless corroborated by the following: (1) Other case reports from independent authors, (2) well-described allergen challenge data, or (3) valid cross-reactivity data.

FDA is providing its report of the collected literature and other data in a data file that is currently available in PDF format on FDA's Web site at http://www.fda.gov/​downloads/​BiologicsBloodVaccines/​Allergenics/​UCM271330.pdf. FDA welcomes comments on the scientific and medical literature and information presented in the data file.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the data file at http://www.fda.gov/​downloads/​BiologicsBloodVaccines/​Allergenics/​UCM271330.pdf or http://www.regulations.gov.

Dated: September 20, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.