The Dark Side of PREA . . . . But is There a Way to Churn the Cream Into Butter and Crawl Out? Catch Me If You Can! March 9, 2026 By Kurt R. Karst —

https://www.thefdalawblog.com/2026/03/the-dark-side-of-prea-but-is-there-a-way-to-churn-the-cream-into-butter-and-crawl-out-catch-me-if-you-can/?utm_source=rss&utm_medium=rss&utm_campaign=the-dark-side-of-prea-but-is-there-a-way-to-churn-the-cream-into-butter-and-crawl-out-catch-me-if-you-can Two little mice fell in a bucket of cream. The first mouse quickly gave up and drowned. The second mouse, wouldn’t quit. He struggled so hard that eventually he churned that cream into butter and crawled out. Gentlemen, as of this moment, I am that second mouse. —Frank Abagnale Sr. (played by the great Christopher Walken) “Two Little Mice” speech from the 2002 film “Catch Me If You Can” FDA’s pediatric assessment requirement—first promulgated as the Pediatric Rule in December 1998, and then transformed into the Pediatric Research Equity Act (“PREA”) in December 2003 (FDC Act § 505B) after the U.S. District Court for the District of Columbia, in October 2002, held in Ass’n of Am. Physicians & Surgeons, Inc. v. United States FDA, 226 F. Supp. 2d 204 (D.D.C. 2002), that the Pediatric Rule exceeded FDA’s authority and invalidated its application—has been a topic of interest for this blogger for decades. The then-Pediatric Rule and then-relatively new pediatric exclusivity incentive added to the statute at FDC Act § 505A by Section 111 of the 1997 FDA Modernization Act (later known as the Best Pharmaceuticals for Children Act, or “BPCA”) was the focus of my first law review article in 2000: Pediatric Testing of Prescription Drugs: The Food and Drug Administration’s Carrot and Stick for the Pharmaceutical Industry, 49 Am. U.L. Rev. 739 (2000).