The Hill featured commentary from Jessica O’Connell on the U.S. Food and Drug Administration’s (FDA) approval of the first new sunscreen filter in more than 20 years, highlighting the regulatory challenges that historically slowed the review of new sunscreen ingredients.
According to Jessica, the FDA had previously maintained that it lacked the resources necessary to fully evaluate new sunscreen filters. For decades, the agency relied on the Time and Extent Application (TEA) pathway for approving over-the-counter drugs, including sunscreens.
"This ingredient in particular was the subject of a Time and Extent application that just kind of lingered for quite some time with FDA, and I think FDA kind of historically said we don't have the resources to really review these," said Jessica. "I think there were some questions around whether FDA thought the data that had been submitted was enough."
Jessica explained that the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 helped advance the review of new sunscreen filters by establishing a more structured regulatory framework and creating incentives for the FDA to devote resources to evaluating submissions.
"There was more incentive for FDA to dedicate resources to reviewing these submissions, because their user fees tied to it, and so it created the process that DSM used for this particular submission," Jessica explained.
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