Latex, Food Allergen Standardization To Occur In Parallel To Asthma Initiative

Standardization of cockroach and mold allergens would occur under the HHS Asthma Initiative without affecting standardization efforts for latex and food allergens, CBER Laboratory of Immunobiochemistry Chief Jay Slater, MD, told FDA's Allergenic Products Advisory Committee.

Under the Asthma Initiative, FDA's Laboratory of Immunobiochemistry would receive additional funding for the standardization of the asthma-related allergens for one and a half years, Slater said Feb. 10.

LIB proposed cockroach, Alternaria alternata and Aspergillus fumigatus as standardization targets during the next three to five years in response to HHS' March 1999 strategic plan.

Committee member Andrew Saxon, MD, UCLA School of Medicine, urged that other allergens included in the panel's 1999 recommendations - pine nut, peanut and latex - be "kept on the overall radar screen."

"I would be more favorably inclined to go along with the recommendation," based on the availability of extra funding that would not "take away from the standardization of other allergens," Committee member Samuel Lehrer, MD, Tulane University Medical Center, said.

Standardizing asthma and other allergens is "not exclusive," Slater replied. Both could be done simultaneously based on "a possibility of budget expansion." Money from the Asthma Initiative for the standardization of the asthma-related allergens should be available for the next year and a half and "thereafter will be built into the budget requests," Slater said.

"I was looking for allergens that were reasonably characterized," and for which the bronchial hyper-reactivity had been well studied, Slater said in explanation of LIB's selections for Asthma Initiative research funding.

"Cockroach is ubiquitous and clearly associated with asthma," especially inner-city asthma, Slater said. He indicated immunotherapy would be an appropriate way "to control the problem of immune response to cockroach as the possible etiology of asthma."

The cockroach allergen was perceived as a reasonable target. "This one might be an easy one to standardize," Allergenic Products Manufacturers Association President Peter Hauck said. Several companies had developed serum pools for the cockroach allergen as part of a previous initiative, he added.

Both industry and committee members expressed concern over the difficulty in standardizing mold. "As far as the fungi go, that might be biting off a bit more than you could chew," Huack said. "I would encourage you to come up with a back-up plan."

The standardization of the fungi allergens might not benefit from "the same approaches that worked so well with grass pollen allergens" because of the variability of fungi, Lehrer said. He recommended limited objectives for the fungi, in case "it turns out this is a much more difficult task than anticipated [and] that it requires greater resources, which would be better spent in other ways."

Referring to fungi, Lehrer raised the question whether "we should just allow extracts to be perhaps of less quality - at least some of them - compared to others."

Committee chair Dennis Ownby, MD, Medical College of Georgia, suggested "you pick one of the molds...and use dog as your third one in terms of asthma." Slater agreed "that there is some rationale for standardizing the dog extract."

Lehrer cautioned that in the future, standardization of allergens may not be able to depend on traditional studies. "If we are relying on information that has been funded by traditional sources that information is not going to be there." He said, "if you want to kiss a grant goodbye, put in a study of allergenic extract."

The committee also recommended the approval of a new algorithm for the standardization of allergens.

The algorithm was designed "to enshrine what is essential about standardization and not let go of it, and yet be flexible enough to deal with a whole variety of standardization issues that may well come up as we look at a new generation of products to standardize," Slater said.

Hauck requested industry play a greater role in the algorithm. Slater responded that the Allergenic Products Manufacturers Association was involved throughout the process.