What is an apt literary metaphor for the U.S. Food and Drug Administration?
The Queen of Hearts from Alice’s Adventures in Wonderland.
The FDA has been called many things: slow, capricious and opaque. But perhaps never before has a critic likened the agency to the villainess of the famous children’s novel. The Queen of Hearts is an all-powerful tyrant who changes the rules of the game as she sees fit.
At an educational event organized by trade group LifeScience Alley Thursday, regulatory expert Mark DuVal drew laughs as he co-opted characters from the popular classic and framed them within the world of the FDA.
Using the color-saturated trailer from Johnny Depp’s Alice in Wonderland, DuVal epitomized the innocent and naive Alice as a company seeking a 510(k), reviewers at the Center for Devices and Radiological Health as Tweedle Dee and Tweedle Dum and the U.S. Congress as the ephemeral Cheshire cat, fading in and out with a wide grin.
In the center of that world of was DuVal himself as the Mad Hatter who must navigate Alice through the topsy-turvy world of product review.
Judging by the tenor of the presentation, there will be no reprieve for the agency as CDRH director Jeffrey Shuren had desired, at least not in Minnesota.