FDA Issues Draft Guidance for Topical Drugs


The U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled, 'Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment.'

This draft guidance provides recommendations for the characterization, during product development, of local safety of topical drug products regarding the risk for contact dermatitis. These recommendations are specifically directed to the development of topical new drug products intended for cutaneous application.

According to a Federal Register notice on the availability of the guidance document, historically, the FDA requested sponsors of new topical drug products to characterize local safety with regard to cutaneous irritation, sensitization, phototoxicity and photoallergy (the latter two only for products that absorb ultraviolet radiation at relevant wavelengths) through the conduct of dedicated “dermal safety studies.” These studies were conducted in healthy volunteers by repeated application of the drug product under occlusion on the skin of the back or upper arm. The studies are considered provocative in that the test condition of occlusion is used to evoke the adverse reaction at a greater rate than might be observed under labeled conditions of use.

The Division of Dermatology and Dental Products (DDDP) became concerned that these provocative studies, conducted under augmented conditions, were not informative for drug development, did not provide information that was useful for labeling, and induced adverse reactions in study subjects that might result in permanent harm.

See related: Skin in the Game, Contact Dermatits and Cosmetics, Part I

The DDDP convened a scientific workshop in September 2018 during which outside experts provided input on the utility of these studies for development of new topical drugs. The consensus of the workshop was that the dedicated dermal safety studies, previously requested by FDA, were not needed to evaluate local cutaneous safety of topical new drug products.

DDDP intends to publish this draft guidance to inform sponsors of new topical drug products intended for cutaneous application of recommendations for evaluating local (cutaneous) safety of topical drug products with regard to contact dermatitis. These recommendations will be specifically directed to developing topical new drug products; the draft guidance will not address over-the-counter drugs under monograph, generic drugs or nondrug cosmetic products or ingredients.

For more information and to submit comments online, visit the FDA website.

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