What is an apt literary metaphor for the U.S. Food and Drug Administration?
The Queen of Hearts character 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 a tyrant who changes the rules of the game as she pleases and is all-powerful.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
At an educational event meant to enlighten the audience about the 510(k) process 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. (The event was organized by local trade group LifeScience Alley.)
Using the color-saturated trailer from Johnny Depp’s Alice in Wonderland, DuVal epitomized the innocent and naive Alice as the 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 course is 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 here in Minnesota.
