“QUICK SUMMARY” OF THE
ALLERGENIC PRODUCTS ADVISORY COMMITTEE TELECONFERENCE
April 8, 2003 at 1:00 p.m. EDT
The Allergenic Products
Advisory Committee meeting was held by videoconference originating in NIH
29B/4NN15. There was a video screen and
speaker phone for public participation located on the first floor of this
building, in Conference Room A. Dr.
Samuel B. Lehrer presided as Chairman for this committee meeting.
Dr. Jay E. Slater, Chief of the Laboratory of
Immunobiochemistry, CBER/FDA, made several presentations to the advisory
committee. First he presented an
overview of the Laboratory, its staffing and lot release activities. Next he addressed operational issues
encountered in the replacement of cat and ragweed antisera. Two sheep being immunized to generate new
antisera were exposed to sheep that were subsequently diagnosed with scrapie (a
transmissible spongiform encephalopathy).
Since there have not been any cases of transmission of scrapie to humans,
the sera from the exposed sheep is almost certainly safe. However, to assure
the highest degree of safety possible, sera from these exposed sheep were
frozen, but will not be used unless CBER runs out of existing sera before new
sera are harvested.
In his next presentation, Dr. Slater explained CBER’s new Laboratory Quality Management Initiative. Under this initiative the Laboratory will come into compliance with International Organization for Standardization (ISO) standard 17025, entitled “General requirements for the competence of testing and calibration laboratories
“. This will require some revision of laboratory
protocols, improved documentation, and internal and third-party audits.
The Committee was then updated on the Laboratory’s
research on the endotoxin content in allergenic extracts. The laboratory found variable endotoxin
content in different sources of allergenic extracts. These initial studies are being expanded and will be confirmed by
a different methodology.
Finally, Dr.
Slater presented the laboratory’s progress in standardizing cockroach allergen
extracts. He reported that
commercially available cockroach allergen extracts vary widely in protein
content and potency. Proposed clinical
studies include skin testing to establish biological unitage and ideal dosing ranges
for cockroach allergen. OVRR/CBER and
the NIAID Inner City Asthma Consortium will collaborate to perform the
necessary clinical and scientific studies to standardize cockroach allergen
vaccines. This, in turn, will enhance the safety and efficacy of these
allergenic products, and will facilitate studies on the role of cockroach
allergy in the etiology of asthma in the inner city.
Throughout all of these
presentations the committee evaluated the current and proposed studies, made
comments and recommendations pertaining to the operational, research and
regulatory activities of the Laboratory.
Please see the transcripts for details of these discussions.
(revised
JES, 4/10/03)