The FDA recently released Draft Guidance that will have a huge impact on allergy practices – if it is not revised.
The Advocacy Council prepared comments and then collaboratively joined with the American College of Allergy, Asthma and Immunology, the American Academy of Otolaryngic Allergy, and Allergy and Asthma Network – as one voice – to submit them to the FDA. While these organizations agree with most of the proposed rule, the section related to the preparation of compounded drugs in an ISO Class 5 environment would seriously limit the ability of most allergists to continue to prepare allergenic extracts in their offices. Our letter specifically requests the FDA to amend the Draft Guidance so the requirements related to allergenic extract preparation in an ISO Class 5 environment do not apply to preparation of allergenic extract prepared in a physician's office.
Other points addressed include:
- Allergists have over 100 years of experience preparing allergenic extract in their offices without a single report of a sterility issue.
- The proposal would limit access of this effective care for the treatment of allergic diseases and would carry significant public health consequences.
- The proposed stringent standards (ISO Class 5 environment) would directly conflict with FDA's Draft Guidance on Mixing, Diluting or Repackaging standards, designed to ensure patients' access to allergenic extract treatment.
- Allergists currently comply with USP Chapter 797 guidelines.
- There is literature demonstrating the sterility of allergenic extracts prepared using aseptic technique.
- Immunotherapy is a proven treatment that is disease-modifying and offers the possibility of a cure to patients of allergic diseases.
- Studies prove allergen immunotherapy reduces health care costs.
- If adopted, this proposal will adversely affect the ability of allergists to bill for extract preparations.
You can help by writing to the FDA and state that you support our comments. This sample template (and submission instructions) is provided as a model for your letter, but please DO NOT copy and paste – paraphrase and use your own words. A single, well-supported comment may carry more weight than a thousand form letters.
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