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Dr. Michael Sinha Co-Authors Article Revisiting the Orphan Drug Act, Published in the New England Journal of Medicine.

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Professor Michael Sinha, JD, MD, MPH co-authored an article entitled “Four Decades of the Orphan Drug Act and Priorities for the Future,” published in this week’s issue of the prestigious New England Journal of Medicine. The article was written in conjunction with Professors Ariel Stern, PhD of the Hasso Plattner Institut and Arti Rai, JD of Duke Law.

The article examines the Orphan Drug Act, passed in 1983 in response to the growing awareness of rare diseases. The Act created incentives for manufacturers to develop orphan drugs, or therapies for diseases that affect fewer than 200,000 people in the United States. While the ODA has had much success, Dr. Sinha and his co-authors suggest that many manufacturers are using the legislation to line their pockets at the expense of consumers.

They write, “Today, manufacturers appear to use rare-disease indications to justify charging steep prices. The median annual cost of an orphan drug was $32,000 in 2019, with more than one third of orphan drugs costing more than $100,000 per year.”

The article will appear in the July 11, 2024 print issue of NEJM and is currently available online.

Profile photo of Dr. Michael SinhaDr. Sinha joined Saint Louis University School of Law’s Center for Health Law Studies faculty in 2022 with an extensive background in law and medicine. He held various research and teaching roles at Harvard Medical School, Northeastern University School of Law, and Loyola University Chicago School of Law. He holds an M.P.H. from Harvard T.H. Chan School of Public Health and an M.D. and J.D. from Southern Illinois University.

Learn more about Dr. Sinha's research

Learn more about the Center for Health Law Studies