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Psoriasis advocacy group, speaking at FDA hearing, urges FDA to approve topical steroids for over-the-counter use
(March 24, 2005) Psoriasis Cure Now, a nonprofit patient advocacy group, today urged a joint hearing of two Food and Drug Administration Advisory Committees to approve for over-the-counter use some topical steroids that currently require a prescription. Topical corticosteroids play a role in psoriasis treatment for the vast majority of the 6.5 million Americans with psoriasis, and these patients would benefit from the convenience and lower cost that OTC status would bring.
“We believe that some of the topical steroids that currently require a prescription could be safely and effectively used by patients in an over-the-counter setting,” said Michael Paranzino, president of Psoriasis Cure Now. “The typical psoriasis patient will face this incurable disease for 50 years or longer. Most of these patients are actively engaged in treating their skin symptoms and have the expertise to use topical products without a prescription.”
Topical steroids come in dozens of variations in drug type and strength. One common classification system lists seven steroid potencies from mild to ultra high, with each of the seven classes offering numerous choices. For about 15 years, the strongest steroid available without a prescription has been hydrocortisone 1%, a very mild formulation.
In its statement to the FDA, the group called for better labeling and other education efforts both for patients and physicians about topical steroids and their potential side effects, and recommended particularly close attention to topical steroid use by pediatric psoriasis patients.
“While we believe additional steroids should be available OTC, we urge the FDA to weight carefully how best to educate parents who face difficult choices about how, and how aggressively, to treat psoriasis in their children,” Paranzino added. “Topical steroids play a role in treating many children with psoriasis, but there are non-steroid alternatives that should also be considered.”
The group also urged the FDA Committees to use their influence with a different government agency, the National Institutes of Health, to urge NIH to increase psoriasis research funding. Psoriasis research funding has been stagnant for a full decade, as NIH funding has doubled.
The Psoriasis Cure Now statement to the FDA committees is available here.
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