Lawyer, Physician, and Bioethicist Takes Over the Reins at FDA’s Orphan Drug Shop

By Kurt R. Karst –      

We have learned that FDA’s Office of Orphan Products Development (“OOPD”) has a new Acting Director.  Debra Lewis, O.D., M.B.A., who is OOPD Deputy Director, and who has been serving as Acting Director since the Departure of Dr. Timothy Coté earlier this year, announced earlier this week that Gayatri Rao, M.D., J.D. will become OOPD Acting Director starting the week of October 10th.  Dr. Rao graduated from the University of Medicine and Dentistry of New Jersey Medical School and earned both her law degree and bioethics masters degree from the University of Pennsylvania.  She comes to OOPD from FDA’s Office of Chief Counsel, thereby “bringing a unique medical and legal/regulatory background to move the OOPD rare disease mission forward,” Dr. Lewis wrote in an e-mail announcement.