FDA Considering Allergy Therapy Guidelines

The U.S. Food and Drug Administration recently assembled a panel to begin developing and encouraging improvement in immunotherapies for allergy sufferers.

The panel discussion involved independent advisers and experts in immunology and medicine in an effort to gain information so that the FDA can begin the framework for guidelines regarding treatments and clinical trials for immunotherapies.

FDA officials are looking for input towards safety guidelines for clinical trials and towards guides for therapies that arise from those trials. Safety issues were a large portion of the discussion, especially the safety of infants and young children who are a primary target group for emerging therapies in food allergy testing.

The broader idea of field trials meant to reduce the rates or severity of reactions were also discussed. Kathleen Hise of the FDA's Division of Vaccines and Related Product Applications mentioned these field trials and encouraging the targeting of biomarkers for this purpose. Some objected to this, citing the lack of definitive research in this field.

A key point of discussion was peanut allergies.

Six participants openly called for the FDA to get immunotherapy guidelines in place quickly, especially for peanut allergies - a key area of research that is often considered one of the most common and most severe of the allergies in the country.

Because there are no guidelines for a standardized testing and treatment program for food allergy therapies, the panel was told, there are no licensed immunotherapies for food allergies.

A key issue facing the development of pharmaceuticals, for example, is a lack of definition for metrics and measures in many areas of allergy study. The many variables that can affect adverse reactions at any given time are often not accounted for in double-blind studies, one researcher pointed out.

Source: Medpagetoday.com

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