FDA takes a fresh look at non-standardized allergenic extracts
Published Online: February 20, 2012
Non-standardized allergen extracts have been used for over a century. Initially, these products were regulated by the National Institutes of Health (NIH), and were not required to have an individualized showing of effectiveness. In 1972, jurisdiction was transferred to FDA, which established external review panels to make recommendations regarding safety and effectiveness. Two panels deliberated between 1974 and 1983. As a result of their deliberations, some products were removed from the US market, but hundreds of allergen extracts for which supportive data were considered lacking (so-called Category IIIA products) remained available on the US market.
In 2003, FDA revisited the effectiveness and safety review that it had begun in 1972. In the interim period, 19 products had been “standardized” and no longer needed to be considered. FDA reviewed the available literature on the remaining 1269 non-standardized products and, considering the scientific data (including clinical trials, case reports, and cross reactivity) established provisional threshold levels of effectiveness. FDA also considered potential safety issues from available scientific and lay literature, as well as from reporting to the FDA’s Adverse Event Reporting System (AERS) from 1987 to 2010.
In a recent issue of The Journal of Allergy and Clinical Immunology (JACI), Slater and co-authors report FDA’s findings. Among 1,269 allergen extracts reviewed, there were 480 for which use in the diagnosis and treatment of allergic disease were addressed in the literature; 207 for which only diagnostic use was addressed; 565 for which minimal or no supportive literature was identified; and 17 for which potential safety concerns were found. In AERS, there were 178 adverse event reports, including 13 deaths, associated with allergen extract use over 23 years. No single group of extracts predominated.
When used according to professional guidelines, nearly all non-standardized allergen extracts for diagnosis and therapy appear to be safe. FDA is considering appropriate regulatory action regarding those 565 products for which minimal or no supportive data were found, and for the 17 products with potential safety issues. Public comment on FDA’s review and potential actions is welcomed through April 25, 2012.
The Journal of Allergy and Clinical Immunology (JACI) is the official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.