Thursday, March 05, 2015

          Health Law Team Wins at Baltimore Competition

          Students utilized practical experience in the pharmaceutical industry and self-study of health law to make their winning case.
          Sample alt tag.
          3L Elizabeth Nicholson, 3L Wesley Hansen, and 2L Laura Hagen with their 3rd place plaque.

          3L Elizabeth Nicholson, 3L Wesley Hansen and 2L Laura Hagen recently returned from Baltimore, MD with honors in the 4th Annual University of Maryland Carey Health Law Regulatory and Compliance competition. 

          Although it was UC Hastings' first time in the competition, the team placed 3rd out of 14 teams, most of which had competitive Health Law teams. Professor Jaime King, who advised the team, said that the students were among the very few that self-studied FDA law instead of taking a formal class on the topic. "We are so proud of the effort that they put into this event and their wonderful success," she said.  

          The Competition required teams of 2-3 students to analyze a hypothetical fact pattern involving stakeholders and entities participating in several health care activities that require regulatory and compliance oversight. The fact pattern was given to teams the day of the competition, and students had approximately 1.5 hours to analyze the problem. The students then had 20 minutes to present findings and recommendations to government attorneys, who were serving as the government's counsel, and 20 minutes to present findings and recommendations to pharmaceutical company attorneys serving as company counsel. The judges were actual professionals working in their respective fields.

          The competition focused on several interactions between various health care stakeholders, including hospitals, physicians, drug and device manufacturers, and related third parties. Specifically, this year's problem challenged students to address several areas, including but not limited to:

          • FDA life-cycle management, including but not limited to pre-clinical research, clinical trials, FDA marketing applications
          • Bioethical research issues, Common Rule, and human research protection issues for drugs, medical devices, and/or biologics
          • FDA post-marketing requirements, including but not limited to labeling, advertising, promotion, manufacturing, and supply chain
          • Healthcare fraud & abuse issues, including the Anti-Kickback Statute and applicable safe harbors and exceptions, Stark Law, exclusion, and the False Claims Act and applicable whistleblower or qui tam provisions

          The students received positive and constructive feedback, particularly from those in the drug industry. "This may have been due to our proximity to Silicon Valley and our experiences working with biotech and pharmaceutical companies," said Nicholson.

          They were also able to network with those industry attorneys, as well as with health law students from the 13 other universities. In addition to their award plaque, each student was given a membership fee waiver to join the Health Law section of the ABA.

          The Health Law team received financial support from the UCSF/UC Hastings Consortium on Law, Science and Health Policy, UC Hastings Student Services, and ASUCH. Professors Marsha Cohen (UC Hastings) and Joel Hoffman (George Mason University) also offered FDA Law expertise and guidance. 

          The competition was hosted by the University of Maryland Francis King Carey School of Law, and sponsored by Arnold & Porter LLP, Ober | Kaler, EpsteinBeckerGreen, American Health Lawyers Association (AHLA), ABA Health Law Section, and the Food and Drug Law Institute (FDLI).

          Students interested in competing next year can e-mail 2L Laura Hagen at lhagen@uchastings.edu.

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