This considerable scientific, financial, and logistical effort remains, in my historical view of the development of allergology and immunology, the most namely remarkable instance where consumers, manufacturers, and regulators took jointly, and at the bench level, their fate in their own hands with the common purpose to improve service to the patients. It is somehow regrettable that these efforts, although provided with enthusiasm by the participants, were not fully crowned by success. The main intent of the allergen standardization project started jointly by the IAACI and IUIS in 1977 had been to establish identical criteria worldwide for evaluation of quality and potency of allergen extracts, including their regulation for use. For that purpose, a collection of internationally recognized Reference Standards had to be established as well.

We must unfortunately recognize that, 30 years later (!!!!!), this goal has still not been achieved. From my own perspective, the main cause for that failure is that the initial tacit agreement between the Food and Drug Administration (FDA) in the United States and various European national regulatory authorities to harmonize methods and regulations dissolved in thin air around the end of the 1980s. This was due to several related factors. The first dent in the wall was the observation that some of the allergen preparations selected as WHO International Standards were not perfect and showed some technical flaws. Instead of being positive about having a usable Reference Standard at all, some found it more rewarding to emphasize more or less minor defects.

From there on, it was a natural trend for some regulators, who by definition must be overcautious, to put in doubt the feasibility of the whole process. The state of legislation and regulation for allergenic products was also at the time still very heterogeneous throughout the world. For the USFDA, obliged by law to regulate allergens, it became somehow inconceivable to have to wait and depend on a slow international harmonization process. Accordingly, the FDA soon went ahead with its own methods, allergen standards, and regulations. The Europeans, on the other hand, endeavored to harmonize various national regulations into a single European directive under the sponsorship of the European Pharmacopoeia.

Therefore, although the whole effort AV-951 had undeniably a very positive effect in improving the quality and the manufacturing processes of allergen extracts put on the market, it did not achieve its original purpose: worldwide standardization. An additional factor became the demotivation of essential partners, the allergen manufacturers. At the start, the motivation of the allergen manufacturers for technical and financial support had been to foster worldwide rules for evaluation and registration of allergens, a potent means to improve efficiency and reduce costs.