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Legal Aspects Of SLIT

The FDA has not yet approved the use of SLIT. This does not mean that the use of SLIT is illegal, just that the FDA considers the oral administration of allergy vaccines to be an off-label use of the allergenic extracts. In order for SLIT to be approved in the US the FDA requires that the efficacy and safety information be based on research done in the US. While the physician can legally use a medication or vaccine beyond the label indications, the insurance companies describe this as “experimental use” and therefore they will usually not cover for services that use an off-label treatment.

The fact that there is an overwhelming amount of good quality scientific evidence attesting to the fact that SLIT is at least as effective as injections and for sure much safer9,10 is of no bearing for the American insurance system. No death has ever been reported after SLIT11 while there are many cases of mortality and other very serious complications after administration of injectable allergy vaccines. 12,13

Even the fact that SLIT administration is cheaper than injections appears to be of no significance for a medical system that usually tries to save money. In summary, most insurance carriers will not reimburse for SLIT administration. This situation is expected to change (hopefully in the near future) as our major academic Allergy Institutions have started to offer courses on SLIT at the yearly national meetings. A joint task force was formed by the American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy Asthma and Immunology (AAAAI), and a comprehensive report of the topic was published in 2006 14 so it is to be hoped that at some point the scientific evidence (that the FDA requires to be acquired in the US) will be collected and then the FDA will realize that SLIT is not only safe in Europe but on this side of the ocean too.

Allergy courses with a component on SLIT can at this time be taken at:

  1. AAOA (American Academy of Otolaryngic Allergy)
  2. AAAAI (American Academy on Asthma Allergy and Immunology)
  3. ACAAI (American College of Allergy, Asthma and Immunology)
  4. PAAS (Pan American Allergy Society)
  5. AAEM (American Academy of Environmental Medicine)
  6. Allergy Choices (Private entity)


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