We live and practice in Utah. We have a thriving ENT and Allergy clinic. Four years ago we started treating our chronic sinusitis patients with allergy immunotherapy in a new way. We expanded our mold panel to include several of the molds the FDA is proposing to make unavailable. These include grain and grass smut, and trichophyton and epidermophyton. We have not conducted any formal studies. However, in our population we treat many farmers and ranchers. I honestly feel it would be a disservice to their health, I'd even go as far as to say a harm to them, to take these things out of their serum. It would also be unfair to the future patients to not offer these antigens as it has improved the health of so many.
There is no doubt an allergy to these things. 75% of our patients are allergic to all of the above mentioned antigens. Allergy immunotherapy, for the correct patient, keeps them off of medication, out of surgery, and out of the doctors office. It has enabled some formerly disabled patients who have suffered from chronic sinusitis and allergies.
Please consider the hopefully overwhelming clinical evidence of these antigens. Their removal from the market would no doubt create a negative wake for the majority of our practice.
Jeffrey G Bennion - Comment
This is comment on Notice
Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts, etc.: Center for Biologics Evaluation and Research; Extension of Comment Period
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