Allergies affect tens of millions of people worldwide, and proper management is a day-in, day-out necessity. To most, if not all, of the sufferers, "allergy drops," as Sublingual Immunotherapy (SLIT) is known to them, would almost seem like an overnight therapy sensation. That said, there is an obvious question on the minds of many: Why wouldn't allergy drops be considered for approval by the FDA?
Allergy drops are a form of immunotherapy that involves placing small amounts of allergen extracts under the tongue. In particular, the process tries to reduce the response of the body to the specific allergen and mitigate an allergic reaction that may occur in the future. This kind of immunotherapy is painless, unlike traditional treatment, which makes use of allergy shots given through a needle and injected into the arms.
The FDA regulates the products that can be used to save lives or better protect society from disease or injury. Through clinical trials, testing is performed on any drug or treatment before it can be used in the USA. Such research studies aim to check treatment safety and effectiveness, along with possible harmful side effects under very specific and limited conditions. The complexity of regulation is one of the major reasons why allergy drops have yet to be approved by the FDA.
The FDA measures standardized dosage levels, which can be administered to any patient, while the dosage of the allergy drops actually varies according to the individual sensitivity of a patient, and thus never has a standard amount. For this reason, the FDA thinks of allergy drops as more of a therapy than a product.
Even with no FDA authorization, many studies have found that allergy drops effectively reduce allergic symptoms. Research has also gone on to establish that allergy drops have been effective in reducing the effects or symptoms of allergic rhinitis. In addition, previous studies had shown that the effects of SLIT, such as a decrease in allergic rhinitis symptom severity, lasted even after stopping the therapy.
At this time, allergy drops have not been approved by the FDA, but the FDA has left a pathway for approval of those therapies open. The FDA has offered several paths concerning the approval of personalized medicine, which include biomarkers and surrogate endpoints to assess the treatment's effectiveness. This could permit researchers to design clinical trials with more power to show the safety and effectiveness of allergy drops. Moreover, many of the ingredients in allergy drops are already approved by the FDA.
FDA approval is no substitute for well-informed healthcare provider instructions on how to take allergy drops. The benefit-risk ratio is something a provider should help a patient decide when assessing if allergy drops are an appropriate therapy for their specific allergies. A provider may also help monitor the toxicity of allergy drops and guide patients to ensure that they get proper extracts from reputable pharmacies.
