Working in teams of two or three, the students had 90 minutes to analyze a hypothetical fact pattern which they were reading for the first time and then present findings and recommendations to a panel of practicing regulatory and compliance attorneys. 33 lawyers from FDA, HHS, and the nation’s most prominent health and life sciences law firms participated as judges.
This year’s competition focused on the FDA drug approval process and bioethical research issues. In previous years, the focus has been on healthcare fraud and abuse, hospitals, payers, the challenges associated with new clinically integrated care models and FDA-regulated clinical trials and associated compliance issues.
“We are extremely proud of our UM Carey law students’ victory this year,” said Professor Diane Hoffmann, longtime director of the school’s nationally ranked Law and Health Care Program. “But given the rigor of this competition, all the student teams demonstrated a winning mastery of incredibly complex legal and regulatory issues. The competition is a terrific opportunity for law students to gain hands-on experience and superb insights from seasoned professionals. We’re thrilled at the Competition’s growth. Teams are coming from as far away as the west coast to compete.”
After the competition, James Valentine ’14, an associate at Hyman, Phelps &McNamara and original organizer of the Competition, provided the gathered competitors and judges with a history of the Competition and an explanation of why he and Abraham Gitterman ’13, an associate in the FDA and Healthcare Practice Group at Arnold & Porter, worked with Hoffmann to create the event in 2012.
To conclude the award ceremony, Amy Comstock Rick, Executive Director of the Food and Drug Law Institute (FDLI) addressed the participants during the celebration luncheon sponsored by Baker Donelson. Ms. Rick spoke to the skill level of the law students in the competition and the value these young attorneys will bring to the critically important field of health care compliance. She described how her experience at FDLI and in prior positions at as the Chief Executive Officer of the Parkinson’s Action Network (PAN) and President of the Coalition for the Advancement of Medical Research helped her understand the critical role that attorneys can play in developing and shaping the structure of the health care system. Ms. Rick also announced the prizes that FDLI would present to the winners of the competition.
The competition was supported by law firms and other organizations, including Baker Donelson, Arnold & Porter, Hyman, Phelps, McNamara, Nelson Mullins, and the American Health Lawyers Association.