This month, Slater et al. report the conclusions from the FDA’s internal review of literature supporting the efficacy of nonstandardized allergen extracts (J Allergy Clin Immunol 2012; 129:1014-1019). The FDA commenced this review in 2003, recognizing that 20 years had passed since the last advisory panel had made recommendations. Additionally, the group used additional resources, such as a greater publication base, in order to expand the search for reliable publications, and the review included consultation of the FDA Adverse Events Reporting System (AERS).
Slater et al. present the interesting historical context for their re-evaluation, beginning with the shift of regulatory responsibility for non-standardized allergenic extracts from the NIH to the FDA in 1972. They note that the FDA convened two separate advisory panels – the first from1974 through 1979 and the second from 1982 through1983 – to recommend classifications for non-standardized allergenic extracts.. The second panel was convened to amend certain previous classification recommendations, as required by a change in the regulations framing the classification process.
The authors discuss extensively the findings of the literature review as well as the review of the current nomenclature. The FDA’s internal committee presented the following results from their review of 1269 allergen extracts:
· 480 extracts used in the diagnosis and treatment of allergic disease were addressed in the literature;
· 207 extracts for diagnostic use only were addressed in the literature;
· 565 extracts had minimal or no supportive literature; and
· 17 extracts were associated with potential safety concerns.
The authors report that almost half of the allergen extracts have little or no data that support their use as a diagnostic and/or therapeutic agent. There is, however, no evidence of product-class safety-specific issues. The committee did identify seventeen extracts as having possible safety concerns.