On Tuesday March 4th, the DePaul Health Law Institute hosted its 2014 Symposium:
The Changing Landscape of Pharmaceutical Law & Business. Over the course of the day speakers from business, legal and ethics backgrounds discussed the past, present and future of pharmaceutical development. Brian Sodikoff, a partner at Katten Muchin Rosenman, LLP, moderated the event that hosted almost 100 attendees throughout the day, with numerous participants joining in via our live stream. Attendees were primarily attorneys receiving CLE credit, DePaul faculty, and students from various law schools in the area, including DePaul and John Marshall.
The first of four panels discussed pharmaceutical regulation and business development over the past twenty years. Brian Annulis, a partner at Meade Roach & Annulis, LLP, was the first to speak and he discussed compliance issues related to the False Claims Act and those related to pharmaceutical "big data" under Anti-Kickback regulations and HIPAA/HITECH. The second speaker was Professor Marty Martin from DePaul's Driehaus School of Business. Professor Martin discussed the traditional business model for pharmaceutical development and how it is likely to change in the future.
The second panel discussed the current state of regulation and included talks from Seth Axelrad, Corporate Counsel for Baxter International, Inc. and Alex Rozenbaum, Product Development Manager at Walgreens. Mr. Axelrad discussed issues relating to generic drug production and its potential to mitigate drug shortages in the future, as well as various regulatory issues that may potentially arise. Mr. Rozenbaum discussed Walgreen's Prescription Saving's Club, a program designed to help uninsured and underinsured save on prescription drugs, as well as other programs at Walgreens designed to lower healthcare costs and improve access to care.
The third panel included three speakers discussing the future of pharmaceutical development and regulation. Christopher Singer from McAndrews Held & Mallow spoke first and he discussed the impact of recent patent decisions on personalized medicine and the potential for drug treatment programs specifically built for each patient. The second speaker was Philip Brewster from Brewster Law Firm. Mr. Brewster discussed the recent "Caronia Decision" and the future of off-label marketing. The final speaker on this panel was Nancy Shalowitz,Senior Counsel at Lundbeck LLC, who discussed potential political issues related to pharmaceutical research and development especially with regards to the 2016 elections.
The final presentation was an ethics discussion by Bette-Jane Crigger, Director of Ethics Policy & Secretary of Council on Ethics & Judicial Affairs at the American Medical Association. Her talk entitled "Thinking about Ethics, Physicians & Industry" discussed various ethics opinions by the AMA and the impact of the AMA's ethics code on pharmaceutical development.
Overall, the Health Law Institute's 2014 symposium was a massive success and every speaker's presentation perfectly complimented those that came before and after it. We at the Health Law Institute thank everyone that was involved in making this a great day and we look forward to next year's symposium!
If you missed this year’s Annual Health Law Symposium, check out the recordings at the links below: