At our second Annual Health Law Year in P/Review event, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine welcomed experts discussing major developments during 2013 and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

Agenda

8:30 – 9:00 AM: Registration/breakfast

9:00 – 9:05 AM: Introductory Remarks

• Greg Curfman, Executive Editor, New England Journal of Medicine

9:05 – 10:00 AM: Affordable Care Act

• Exchanges – Wendy Mariner, Professor of Law, Edward R. Utley Professor of Health Law, Bioethics & Human Rights, and Professor of Socio-Medical Sciences and Community Medicine at Boston University
• Medicaid Expansion – Abigail R. Moncrieff, Peter Paul Career Development Professor and Associate Professor of Law, Boston University
• Q&A

10:00 – 10:25 AM: Medical malpractice

• New developments – Michelle Mello, Professor of Law and Public Health, Harvard School of Public Health
• Q&A

10:25-10:40 – Break

10:40 AM – 12:00 PM: Food and Drug Administration

• Drug/device liability and state law – Peter Grossi, Lecturer on Law, Harvard Law School
• Breakthrough therapy – Aaron S. Kesselheim, Assistant Professor of Medicine, Harvard Medical School
• Stem cell regulation – Patrick L. Taylor, Assistant Clinical Professor of Pediatrics, Children’s Hospital
• Q&A

12:00 – 12:45 PM: Break for lunch

12:45 – 1:40 PM: Abortion/Contraception

• Abortion regulation strategy – I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie Flom Center, Harvard Law School
• Contraceptives coverage mandate litigation – Holly Fernandez Lynch, Executive Director of the Petrie-Flom Center, Harvard Law School
• Q&A

1:40 – 2:35 PM: Life science IP

• Recent cases and implications for industry – Claire Laporte, Partner, Foley Hoag LLP
• Disclosure of FDA approval information – W. Nicholson Price II, Academic Fellow, Petrie-Flom Center, Harvard Law School
• Q&A

2:35 – 2:50 PM: Break

2:50 – 3:45 PM: Public health policy

• Tobacco, obesity, vaccination, and more – Wendy E. Parmet, Associate Dean for Academic Affairs and George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University
• Organ donation and sale – I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie Flom Center, Harvard Law School
• Q&A

3:45 – 4:45 PM: Human subjects research

• Data transparency and compensation for injury – Mark Barnes, Partner, Ropes & Gray LLP
• SUPPORT study, Common Rule and Helsinki revisions – Greg Koski, Director of Clinical Research, Division of Cardiovascular Anesthesia, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare System
• Q&A

4:45 – 5:00 PM: Concluding remarks

• Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Slide Presentations

• Peter Grossi, “FDA’s Plan to Require Generic Companies to Modify Drug Labels Independently of Brand Name Labels“
• Holly Fernandez Lynch, “Contraceptive Coverage Mandate and Litigation“
• Claire Laporte, “Recent Cases and Implications for Industry“
• W. Nicholson Price II, “Clinical Trial Data Disclosure“
• Wendy E. Parmet, “Tobacco, Obesity, Vaccination, and More“
• Mark Barnes, “Data Sharing and Compensation for Clinical Trial Injuries in India“

Recording

This event is supported by the Oswald DeN. Cammann Fund.