Food and Drug Administration reclassification of allergens for diagnosis and treatment: now is the time to be heard

Abstract

Allergen-specific immunotherapy has been practiced for more than a century, [1] Noon L. Prophylactic inoculation against hay fever. Lancet. 1911; 1: 1572-1573 Abstract Scopus (1116) Google Scholar with the first allergen extracts being prepared in a noncommercial setting in laboratories associated with allergy treatment clinics. 2 Cooke R. The treatment of hay fever by active immunization. Laryngoscope. 1915; 25: 108-112 Crossref Google Scholar , 3 Cohen S.G. Frankland A.W. Dworetzky M. Noon and Freeman on prophylactic inoculation against hay fever. J Allergy Clin Immunol. 2003; 111: 1142-1150 Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar Subsequently, allergen extract manufacturers started to provide the allergen solutions needed to formulate immunotherapy extracts or vaccines. Initially, conditions and methods of preparation were variable, but as US agencies, such as the Food and Drug Administration (FDA), began examining these companies and manufacturers started to invest in better production and quality control technologies, the conditions of the preparation of allergen extracts have improved markedly. A more detailed discussion on how the manufacturing of the allergen extracts evolved and how this industrial process was supervised by the Hygienic Laboratory of Public Health and Marine Hospital Service and since 1972 by the FDA, can be found in a recent publication. [4] Slater J.E. Menzies S.L. Bridgewater J. et al. The US Food and Drug Administration review of the safety and effectiveness of nonstandardized allergen extracts. J Allergy Clin Immunol. 2012; (Epub ahead of print) PubMed Google Scholar