Allergenic Extract Data Search Parameters Should Be Widened, Cmte. Says

FDA should expand its data search boundaries for the reclassification of allergenic extracts, its Allergenic Products Advisory Committee said.

FDA's Division of Bacterial, Parasitic and Allergenic Products will search medical publications and the agency's adverse event reporting system for safety and efficacy data on extracts labeled Category IIIA.

"You might have to reconsider and add a third search to some questions - that being Google," committee member Susan MacDonald (Johns Hopkins University) said. "I would say you have to cast a wider net."

The committee met April 7 to discuss FDA's strategy for reclassifying allergenic products designated as Category IIIA by the Panel on Review of Allergenic Extracts that met from 1974 to 1979.

[Editor's Note: To ¹ order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

Category IIIA products are those for which data are insufficient for classification but which are thought to have a favorable risk-benefit ratio and should remain on the market pending completion of testing.

When the panel finally issued its category recommendations in 1981, the agency had already decided that the products could not remain Category IIIA.

To remedy this situation, FDA convened a reclassification panel in 1982-1983 which recommended most Category IIIA allergenic products be reclassified as Category I for diagnostic purposes (² (Also see "CATEGORY IIIB ALLERGENIC EXTRACTS LICENSES BEING REVOKED BY FDA" - Pink Sheet, 28 Nov, 1994.), T&G-5).

Category I is defined as safe, effective and not misbranded. Category II is defined as unsafe, ineffective or misbranded.

Certain pollens, molds, avian/mammalian extracts and inhalants were recommended for reclassification as Category II, instead of Category I. The panel also recommended that species definition be required for reclassification into Category I.

For therapeutic uses, the panel recommended pollen extracts, mammalian/avian extracts and many mold and insect extracts be Category I.

Miscellaneous inhalants and all food extracts were recommended for reclassification into Category II.

FDA never implemented the original recommendations of the reclassification panel, but the agency is now committed to removing products from the Category IIIA class.

"It just was not a priority during that interim period," Division of Bacterial, Parasitic and Allergenic Products Laboratory of Immunobiochemistry Chief Jay Slater explained. "It was something that everyone was fully aware was happening and that needed to be done. The decision has now been made that it is a priority and we are going to do it."

The agency will analyze data from 1972 to the present on the roughly 1,200 allergenic extracts designated as Category IIIA to determine their proper classification. The committee will not reanalyze Category I or standardized products.

"If we have a product that we know...is effective both from old data and from continuing data and we have no evidence of safety problems...and we have cross-reactivity data linking that product to several other products, then my guess is we would probably err on the side of allowing those products to remain," he said.

However, "if 20 years after the panel requested that the data be produced there really are no data to support the efficacy of the product, then" there is a chance the product will be placed into Category II, Slater added.

The agency will devote a staff of 10 to the process. The reclassification could take between six and 10 months.

After completing the data review, FDA will issue a proposed rule on the reclassification of allergenic extracts which will include the full list of reclassifications of the Category IIIA products.

The rule will also contain provisions for the revocation of the licenses of those products reclassified as Category II for both therapy and diagnosis.

The agency plans to present the completed list to the committee "around the time or shortly before the proposed rule."