What is the current situation with FDA approval and Sublingual Immunotherapy?

Briefly, SLIT allergy drops treatment is an off-label use of primarily FDA-approved antigens. This means that FDA regulations and safety standards are in effect for these antigens, but the antigens were originally approved for a different purpose (in this case, allergen skin testing and for environmental allergens, allergy shots).

Off-label treatments and procedures are completely legal and are prominent in good quality healthcare. In fact, without a physician’s ability to use his or her expertise and knowledge in a particular area to troubleshoot an issue for a patient and use or do something “off-label” that might help, many patients would unnecessarily have worse outcomes since no FDA-approved treatment can be standardized, studied, and subsequently approved for each appropriate disease in each appropriate age group or scenario. It often goes unrecognized that many pediatric treatments are actually off-label use of FDA-approved medications, for example. And that sometimes, off-label treatments are even safer and/or more effective than available FDA-approved treatments, or are listed as the “standard of care.” There has been a lot of confusion injected around the terms “FDA-approval” and “off-label use” leading to extremely inappropriate and dangerous interference by insurance companies and business administrators who incorrectly classify off-label usage as unsafe or ineffective and then deny patients coverage of important beneficial treatments recommended by their physicians based on this unfounded claim. Therefore, it is crucial that you as a patient understand the true meanings of these terms in order to best assess your own health care decisions and treatment options and in order to make your health care decisions in collaboration with your trusted physician.

The route of using the sublingual area of the mouth for allergen immunotherapy has also been approved by the FDA. There are now a growing number of FDA-approved single environmental-allergen SLIT tablets available. While these work well for some patients, especially those with mild-moderate seasonal allergies to only that one type of major allergen, many people find these tablets to be too strong for them and can experience short-term side effects or even long-term adverse effects stemming from too much allergen exposure in the GI tract. Additionally, these tablets only treat one type of allergen at a time, are currently only available for a few major environmental allergens, are expensive, do not treat food allergens, and are not suitable for young children. This leaves everyone with multiple significant allergies, young children, and/or food allergies still without a fully “FDA-approved” sublingual immunotherapy option and well-served by off-label sublingual use of FDA-regulated antigens.